Myrror: VEGF Trap-Eye in Choroidal Neovascularization Secondary to Pathologic Myopia (mCNV)

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01249664
• Collaborator: Regeneron Pharmaceuticals (Industry)
• Enrollment: 122
• Locations: 20
• Arms: 2
• Duration (Months): 32
• Patients Per Site: 6.1
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

VEGF Trap-Eye will be tested for safety and efficacy in patients with vision loss due to choroidal neovascularization secondary to pathologic myopia. This will be a placebo-controlled trial. 3 out of 4 patients will receive an injection of VEGF Trap-Eye into the affected eye (and repeated injections if required), and 1 out of 4 patients will receive a sham injection requiring no needle stick, but making the patient unaware of whether or not he received active treatment.

Outcome of the two treatment groups will be compared after 24 weeks. From week 24, sham patients may receive active treatment.

Total duration of the study will be 48 weeks.

Condition or Disease	Intervention/Treatment	Phase
Myopia, Pathological	Biological: VEGF Trap-Eye (BAY86-5321); Procedure: No Drug	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 122 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase-3, Multi-center, Randomized, Double-masked, Sham-controlled Study of the Efficacy, Safety, and Tolerability of Intravitreal VEGF Trap-Eye in Subjects With Choroidal Neovascularization Secondary to Pathologic Myopia
• Study Start Date: Dec 1, 2010
• Actual Primary Completion Date: Feb 1, 2013
• Actual Study Completion Date: Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Biological: VEGF Trap-Eye (BAY86-5321); 1 intravitreal injection of the experimental drug, followed by monthly re-injections if needed
Sham Comparator: Arm 2	Procedure: No Drug; Sham procedure NOT involving injection of any substance; patient´s eye is anesthetized and a syringe without needle gently pressed on the cornea

Outcome Measures

Primary Outcome Measures

1. Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) From Baseline to Week 24 - Last Observation Carried Forward (LOCF) [Baseline, Week 24]

   Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning.

Secondary Outcome Measures

1. Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS at Week 24 Using the LOCF Approach [Baseline, Week 24]

   Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.

2. Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS From Baseline to Week 24 - Observed Cases [Baseline, Week 24]

   Data as observed at visit, no carrying forward from latest observation if missing data at later time points. Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning.

3. Percentage of Participants Who Gained at Least 10 Letters in BCVA at Week 24 - LOCF [Baseline, Week 24]

   Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.

4. Percentage of Participants Who Gained at Least 5 Letters in BCVA at Week 24 - LOCF [Baseline, Week 24]

   Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.

5. Percentage of Participants Who Gained at Least 15 Letters in BCVA at Week 48 - LOCF [Baseline, Week 48]

   Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.

6. Percentage of Participants Who Gained at Least 10 Letters in BCVA at Week 48 - LOCF [Baseline, Week 48]

   Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.

7. Percentage of Participants Who Gained at Least 5 Letters in BCVA at Week 48 - LOCF [Baseline, Week 48]

   Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.

8. Percentage of Participants Who Lost at Least 15 Letters in BCVA at Week 24 - LOCF [Baseline, Week 24]

   Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.

9. Percentage of Participants Who Lost at Least 10 Letters in BCVA at Week 24 - LOCF [Baseline, Week 24]

   Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.

10. Percentage of Participants Who Lost at Least 5 Letters in BCVA at Week 24 - LOCF [Baseline, Week 24]

    Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.

11. Percentage of Participants Who Lost at Least 15 Letters in BCVA at Week 48 - LOCF [Baseline, Week 48]

    Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.

12. Percentage of Participants Who Lost at Least 10 Letters in BCVA at Week 48 - LOCF [Baseline, Week 48]

    Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.

13. Percentage of Participants Who Lost at Least 5 Letters in BCVA at Week 48 - LOCF [Baseline, Week 48]

    Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.

14. Mean Change in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) From Baseline to Week 24 - LOCF [Baseline, Week 24]

    A negative number indicates improvement (reduced thickness).

15. Mean Change in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) From Baseline to Week 48 - LOCF [Baseline, Week 48]

    A negative number indicates improvement (reduced thickness).

16. Mean Change in Choroidal Neovascularization (CNV) Lesion Size as Assessed by Fluorescein Angiography (FA) From Baseline to Week 24 - LOCF [Baseline, Week 24]

    CNV area values measured in square millimeters, each disc area is equivalent to 2.54 mm^2 on the retina; lower values represent better outcomes

17. Mean Change in Choroidal Neovascularization (CNV) Lesion Size as Assessed by Fluorescein Angiography (FA) From Baseline to Week 48 - LOCF [Baseline, Week 48]

    CNV area values measured in square millimeters, each disc area is equivalent to 2.54 mm^2 on the retina; lower values represent better outcomes

18. Mean Change in European Five-dimensional Health Scale (EQ-5D) Score From Baseline to Week 24 - LOCF [Baseline, Week 24]

    EQ-5D is a quality of life questionnaire based on a scale from -0.594 (worst) to 1.00 (best).

19. Mean Change in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score From Baseline to Week 24 - LOCF [Baseline, Week 24]

    The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight.

20. Percentage of Participants Who Were Withdrawn From Study Drug During the First 24 Weeks [Baseline, Week 24]

21. Mean Change in Area of Leakage From Baseline at Week 24 - LOCF [Baseline, Week 24]

    A negative change from baseline indicates improvement, ie, less leakage.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Able to read (or, if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent form or a family member) and understand the informed consent form and willing to sign the informed consent form

• Signed informed consent form. In Japan only, the informed consent form for a subject under the age of 20 years will require the co-signature of the subject's legally authorized representative.

• Men and women ≥ 18 years of age

• Myopia of greater than or equal to -6 D OR axial length of greater than or equal to 26.5 mm

• Active subfoveal or juxtafoveal (within 1 to 199 μm of the center of the fovea) CNV secondary to pathologic myopia as defined by leakage on FA

• Best-corrected visual acuity of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye at 4 meters

• Decrease in vision in the study eye is determined by the investigator, using his/her medical judgment, to be primarily the result of the current active mCNV

• Willing, committed, and able to return for all clinic visits and complete all study-related procedures

Exclusion Criteria:

• Only one functional eye

• Ocular media of insufficient quality to obtain fundus and OCT images in the study eye

• Greatest linear dimension (GLD) of the lesion in the study eye is greater than 12 disc areas

• Recurrent mCNV in the study eye

• Aphakia in the study eye

• History or presence of CNV with an origin other than pathologic myopia in the study eye

• Ocular inflammation or external ocular inflammation in the study eye

• Concurrent disease in the study eye that would compromise BCVA or require medical or surgical intervention during the study period

• Any ocular disorder in the study eye that, in the opinion of the investigator, may confound interpretation of the study results

• Significant scarring or atrophy in the fovea that indicates substantial irreversible vision loss in the study eye

• History of idiopathic or autoimmune-associated uveitis in either eye

• Evidence at examination of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye or current treatment for serious systemic infection

• Vitreomacular traction or traction retinal detachment, epiretinal membrane in either eye

• Any iris neovascularization and/or vitreous hemorrhage in either eye

• Uncontrolled glaucoma, or previous filtration surgery in either eye

• Prior and concomitant treatments

• In the study eye:

• Any prior or concomitant treatment with another investigational agent for mCNV

• Any previous panretinal photocoagulation or subfoveal thermal laser therapy

• Any prior treatment with photodynamic therapy

• Cataract surgery within 3 months prior to Day 1

• Yttrium-aluminum-garnet laser capsulotomy within 2 months prior to Day 1

• Any other intraocular surgery within 3 months prior to Day 1

• History of vitreoretinal surgery and/or scleral buckle surgery

• Any prior treatment with anti-VEGF agents

• Previous use of intraocular or periocular corticosteroids in either eye within 3 months prior to Day 1

• Previous assignment to treatment during this study

• Uncontrolled hypertension

• History of cerebrovascular disease or myocardial infarction within 6 months prior to Baseline/Day 1

• History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, may affect interpretation of the results of the study, or renders the subject at high risk from treatment complications

• Women of childbearing potential without contraception, women who intend to breastfeed during the study. All subjects (both men and women) of childbearing potential who are unwilling to use adequate birth control measures during the course of the study.

• Renal failure requiring dialysis or renal transplant

• Participation in an investigational study within 30 days prior to Screening/Visit 1 that involved treatment with any drug (excluding vitamins and minerals) or device

• Known serious allergy to the fluorescein sodium for injection in angiography or Verteporfin

• Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Kowloon		Hong Kong
2		Nagoya	Aichi	Japan	466-8560
3		Nagoya	Aichi	Japan	467-8602
4		Urayasu	Chiba	Japan	279-0021
5		Matsuyama	Ehime	Japan	790-8524
6		Sendai	Miyagi	Japan	984-8560
7		Suita	Osaka	Japan	565-0871
8		Otsu	Shiga	Japan	520-2192
9		Bunkyo-ku	Tokyo	Japan	113-8519
10		Chiyoda-ku	Tokyo	Japan	101-8309
11		Shinjuku-ku	Tokyo	Japan	160-8582
12		Fukuoka		Japan	812-8582
13		Fukushima		Japan	960-1295
14		Kyoto		Japan	606-8507
15		Osaka		Japan	545-8586
16		Osaka		Japan	558-8558
17		Seoul		Korea, Republic of	137 701
18		Singapore		Singapore	168751
19		Taipei		Taiwan	11217
20		Taoyuan		Taiwan	333

Sponsors and Collaborators

• Bayer
• Regeneron Pharmaceuticals

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01249664
• Other Study ID Numbers: 15170
• First Posted: Nov 30, 2010
• Last Update Posted: May 5, 2014
• Last Verified: Apr 1, 2014

• Keywords provided by , ,: sham-controlled; pathologic myopia; mCNV; choroidal neovascularization; intravitreal injection; vision loss; macular damage
• Additional relevant MeSH terms: Myopia; Choroidal Neovascularization; Myopia, Degenerative; Neovascularization, Pathologic; Aflibercept

Study Results

Participant Flow

Recruitment Details	The study was conducted at 20 study centers in 5 countries. Recruitment period: 17 Dec 2010 - 28 Feb 2013.
Pre-assignment Detail	A total of 173 participants were screened.

Arm/Group Title	Aflibercept Injection First, Then Aflibercept or Sham	Sham Treatment First, Then Aflibercept Injection or Sham
Arm/Group Description	Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Period Title: Overall Study
STARTED	91	31
Participants Received Treatment	91	31
Fulfilled Requirements of FAS Population	90	31
Completed 24 Weeks Treatment	83	25
Completed 48 Weeks Treatment	78	24
COMPLETED	85	31
NOT COMPLETED	6	0

Baseline Characteristics

Arm/Group Title	Aflibercept Injection First, Then Aflibercept or Sham	Sham Treatment First, Then Aflibercept Injection or Sham	Total
Arm/Group Description	Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Total of all reporting groups
Overall Participants	90	31	121
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	58.5 (13.7)	57.5 (12.1)	58.2 (13.3)
Sex: Female, Male (Count of Participants)
Female	65 72.2%	27 87.1%	92 76%
Male	25 27.8%	4 12.9%	29 24%
Baseline Best Corrected Visual Acuity (BCVA) letter scores (Letters correctly read) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Letters correctly read]	56.4 (9.8)	56.6 (8.9)	56.5 (9.5)
Baseline Central Retinal Thickness by Optical Coherence Tomography (OCT) (µm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [µm]	349.7 (91.3)	354.2 (107.2)	350.9 (95.2)
Baseline intraocular pressure (mm Hg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm Hg]	15.2 (2.7)	15.8 (2.8)	15.4 (2.7)
Number of participants by category of time since mCNV diagnosis (Number) [Number]
>= 2 months	17 18.9%	7 22.6%	24 19.8%
< 2 months	73 81.1%	24 77.4%	97 80.2%
Baseline National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) total score (scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [scores on a scale]	70.47 (13.48)	72.73 (15.29)	71.04 (13.94)
European questionnaire 5 dimensions (EQ-5D) total score (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	0.88 (0.18)	0.88 (0.15)	0.88 (0.18)
Race (Number) [Number]
Asian	90 100%	31 100%	121 100%
White	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Baseline Choroidal neovascularization (CNV) size (disc area) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [disc area]	0.4086 (0.5028)	0.3334 (0.3413)	0.3894 (0.4666)
Baseline area of leakage (disc area) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [disc area]	0.7005 (0.6830)	0.6867 (0.5563)	0.6970 (0.6507)
Duration of disease (days) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [days]	145.6 (437.4)	177.1 (512.0)	153.7 (455.6)
Baseline axial length (millimeter (mm)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [millimeter (mm)]	28.791 (1.524)	28.610 (1.696)	28.745 (1.564)

Outcome Measures

1. Primary Outcome

Title	Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) From Baseline to Week 24 - Last Observation Carried Forward (LOCF)
Description	Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aflibercept Injection First, Then Aflibercept or Sham	Sham Treatment First, Then Aflibercept Injection or Sham
Arm/Group Description	Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Measure Participants	90	31
Mean (Standard Deviation) [Letters correctly read]	12.1 (8.3)	-2.0 (9.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aflibercept Injection First, Then Aflibercept or Sham, Sham Treatment First, Then Aflibercept Injection or Sham
	Comments	Null hypothesis was equality in change from baseline to Week 24 in BCVA total letter score between Eylea and Sham.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	No adjustment on P value, this is for the primary efficacy analysis.
	Method	ANCOVA
	Comments	ANCOVA model, including treatment groups and country (country designations) as fixed effects and baseline BCVA as a covariate.
Method of Estimation	Estimation Parameter	Difference in least square means
	Estimated Value	14.1
	Confidence Interval	(2-Sided) 95%; 10.8 to 17.4
	Parameter Dispersion	Type: Value:
	Estimation Comments	The difference is calculated as Eylea minus Sham. A positive value indicates Eylea showed a higher change in BCVA total score until week 24 compared to Sham.

2. Secondary Outcome

Title	Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS at Week 24 Using the LOCF Approach
Description	Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aflibercept Injection First, Then Aflibercept or Sham	Sham Treatment First, Then Aflibercept Injection or Sham
Arm/Group Description	Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Measure Participants	90	31
Number [Percentage of participants]	38.9 43.2%	9.7 31.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aflibercept Injection First, Then Aflibercept or Sham, Sham Treatment First, Then Aflibercept Injection or Sham
	Comments	Null hypothesis of difference of Eylea minus Sham of 0 was tested.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments	No adjustment on P value, since this test was only conducted formally under the primary efficacy evaluation was significant.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	CMH adjusted difference
	Estimated Value	29.2
	Confidence Interval	(2-Sided) 95%; 14.4 to 44.0
	Parameter Dispersion	Type: Value:
	Estimation Comments	A two-sided Cochran-Mantel-Haenszel method at level 5% weight-adjusted by country (country designations) was used to conduct the superiority test.

3. Secondary Outcome

Title	Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS From Baseline to Week 24 - Observed Cases
Description	Data as observed at visit, no carrying forward from latest observation if missing data at later time points. Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aflibercept Injection First, Then Aflibercept or Sham	Sham Treatment First, Then Aflibercept Injection or Sham
Arm/Group Description	Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Measure Participants	84	25
Mean (Standard Deviation) [Letters correctly read]	12.0 (8.4)	-0.8 (9.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aflibercept Injection First, Then Aflibercept or Sham, Sham Treatment First, Then Aflibercept Injection or Sham
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference in least square means
	Estimated Value	13.1
	Confidence Interval	(2-Sided) 95%; 9.4 to 16.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Percentage of Participants Who Gained at Least 10 Letters in BCVA at Week 24 - LOCF
Description	Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aflibercept Injection First, Then Aflibercept or Sham	Sham Treatment First, Then Aflibercept Injection or Sham
Arm/Group Description	Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Measure Participants	90	31
Number [Percentage of participants]	63.3 70.3%	12.9 41.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aflibercept Injection First, Then Aflibercept or Sham, Sham Treatment First, Then Aflibercept Injection or Sham
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	CMH adjusted difference
	Estimated Value	50.5
	Confidence Interval	(2-Sided) 95%; 35.0 to 66.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Percentage of Participants Who Gained at Least 5 Letters in BCVA at Week 24 - LOCF
Description	Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aflibercept Injection First, Then Aflibercept or Sham	Sham Treatment First, Then Aflibercept Injection or Sham
Arm/Group Description	Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Measure Participants	90	31
Number [Percentage of participants]	83.3 92.6%	19.4 62.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aflibercept Injection First, Then Aflibercept or Sham, Sham Treatment First, Then Aflibercept Injection or Sham
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	CMH adjusted difference
	Estimated Value	64.0
	Confidence Interval	(2-Sided) 95%; 47.8 to 80.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Percentage of Participants Who Gained at Least 15 Letters in BCVA at Week 48 - LOCF
Description	Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.
Time Frame	Baseline, Week 48

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aflibercept Injection First, Then Aflibercept or Sham	Sham Treatment First, Then Aflibercept Injection or Sham
Arm/Group Description	Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Measure Participants	90	31
Number [Percentage of participants]	50.0 55.6%	29.0 93.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aflibercept Injection First, Then Aflibercept or Sham, Sham Treatment First, Then Aflibercept Injection or Sham
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0308
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	CMH adjusted difference
	Estimated Value	21.0
	Confidence Interval	(2-Sided) 95%; 1.9 to 40.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Percentage of Participants Who Gained at Least 10 Letters in BCVA at Week 48 - LOCF
Description	Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.
Time Frame	Baseline, Week 48

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aflibercept Injection First, Then Aflibercept or Sham	Sham Treatment First, Then Aflibercept Injection or Sham
Arm/Group Description	Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Measure Participants	90	31
Number [Percentage of participants]	68.9 76.6%	41.9 135.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aflibercept Injection First, Then Aflibercept or Sham, Sham Treatment First, Then Aflibercept Injection or Sham
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0075
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	CMH adjusted difference
	Estimated Value	27.0
	Confidence Interval	(2-Sided) 95%; 7.2 to 46.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Percentage of Participants Who Gained at Least 5 Letters in BCVA at Week 48 - LOCF
Description	Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.
Time Frame	Baseline, Week 48

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aflibercept Injection First, Then Aflibercept or Sham	Sham Treatment First, Then Aflibercept Injection or Sham
Arm/Group Description	Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Measure Participants	90	31
Number [Percentage of participants]	87.8 97.6%	45.2 145.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aflibercept Injection First, Then Aflibercept or Sham, Sham Treatment First, Then Aflibercept Injection or Sham
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	CMH adjusted difference
	Estimated Value	42.7
	Confidence Interval	(2-Sided) 95%; 23.7 to 61.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Percentage of Participants Who Lost at Least 15 Letters in BCVA at Week 24 - LOCF
Description	Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aflibercept Injection First, Then Aflibercept or Sham	Sham Treatment First, Then Aflibercept Injection or Sham
Arm/Group Description	Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Measure Participants	90	31
Number [Percentage of participants]	0 0%	6.5 21%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aflibercept Injection First, Then Aflibercept or Sham, Sham Treatment First, Then Aflibercept Injection or Sham
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1478
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	CMH adjusted difference
	Estimated Value	-6.5
	Confidence Interval	(2-Sided) 95%; -15.2 to 2.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Secondary Outcome

Title	Percentage of Participants Who Lost at Least 10 Letters in BCVA at Week 24 - LOCF
Description	Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aflibercept Injection First, Then Aflibercept or Sham	Sham Treatment First, Then Aflibercept Injection or Sham
Arm/Group Description	Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Measure Participants	90	31
Number [Percentage of participants]	0 0%	25.8 83.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aflibercept Injection First, Then Aflibercept or Sham, Sham Treatment First, Then Aflibercept Injection or Sham
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0006
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	CMH adjusted difference
	Estimated Value	-25.8
	Confidence Interval	(2-Sided) 95%; -40.6 to -11.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Secondary Outcome

Title	Percentage of Participants Who Lost at Least 5 Letters in BCVA at Week 24 - LOCF
Description	Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aflibercept Injection First, Then Aflibercept or Sham	Sham Treatment First, Then Aflibercept Injection or Sham
Arm/Group Description	Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Measure Participants	90	31
Number [Percentage of participants]	3.3 3.7%	35.5 114.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aflibercept Injection First, Then Aflibercept or Sham, Sham Treatment First, Then Aflibercept Injection or Sham
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	CMH adjusted difference
	Estimated Value	-32.2
	Confidence Interval	(2-Sided) 95%; -48.1 to -16.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

12. Secondary Outcome

Title	Percentage of Participants Who Lost at Least 15 Letters in BCVA at Week 48 - LOCF
Description	Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.
Time Frame	Baseline, Week 48

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aflibercept Injection First, Then Aflibercept or Sham	Sham Treatment First, Then Aflibercept Injection or Sham
Arm/Group Description	Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Measure Participants	90	31
Number [Percentage of participants]	1.1 1.2%	6.5 21%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aflibercept Injection First, Then Aflibercept or Sham, Sham Treatment First, Then Aflibercept Injection or Sham
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2446
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	CMH adjusted difference
	Estimated Value	-5.3
	Confidence Interval	(2-Sided) 95%; -14.4 to 3.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

13. Secondary Outcome

Title	Percentage of Participants Who Lost at Least 10 Letters in BCVA at Week 48 - LOCF
Description	Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.
Time Frame	Baseline, Week 48

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aflibercept Injection First, Then Aflibercept or Sham	Sham Treatment First, Then Aflibercept Injection or Sham
Arm/Group Description	Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Measure Participants	90	31
Number [Percentage of participants]	1.1 1.2%	22.6 72.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aflibercept Injection First, Then Aflibercept or Sham, Sham Treatment First, Then Aflibercept Injection or Sham
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0035
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	CMH adjusted difference
	Estimated Value	-21.5
	Confidence Interval	(2-Sided) 95%; -35.9 to -7.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

14. Secondary Outcome

Title	Percentage of Participants Who Lost at Least 5 Letters in BCVA at Week 48 - LOCF
Description	Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 35 letters (ETDRS equivalent of 20/40 to 20/200) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.
Time Frame	Baseline, Week 48

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aflibercept Injection First, Then Aflibercept or Sham	Sham Treatment First, Then Aflibercept Injection or Sham
Arm/Group Description	Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Measure Participants	90	31
Number [Percentage of participants]	3.3 3.7%	29.0 93.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aflibercept Injection First, Then Aflibercept or Sham, Sham Treatment First, Then Aflibercept Injection or Sham
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0012
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	CMH adjusted difference
	Estimated Value	-25.7
	Confidence Interval	(2-Sided) 95%; -41.3 to -10.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

15. Secondary Outcome

Title	Mean Change in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) From Baseline to Week 24 - LOCF
Description	A negative number indicates improvement (reduced thickness).
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aflibercept Injection First, Then Aflibercept or Sham	Sham Treatment First, Then Aflibercept Injection or Sham
Arm/Group Description	Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Measure Participants	90	31
Mean (Standard Deviation) [microns]	-79.1 (83.7)	-4.2 (127.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aflibercept Injection First, Then Aflibercept or Sham, Sham Treatment First, Then Aflibercept Injection or Sham
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference in least square means
	Estimated Value	-77.9
	Confidence Interval	(2-Sided) 95%; -108.9 to -46.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

16. Secondary Outcome

Title	Mean Change in Central Retinal Thickness (CRT) as Assessed by Optical Coherence Tomography (OCT) From Baseline to Week 48 - LOCF
Description	A negative number indicates improvement (reduced thickness).
Time Frame	Baseline, Week 48

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aflibercept Injection First, Then Aflibercept or Sham	Sham Treatment First, Then Aflibercept Injection or Sham
Arm/Group Description	Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Measure Participants	90	31
Mean (Standard Deviation) [microns]	-83.1 (85.5)	-56.7 (119.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aflibercept Injection First, Then Aflibercept or Sham, Sham Treatment First, Then Aflibercept Injection or Sham
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0650
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference in least square means
	Estimated Value	-29.3
	Confidence Interval	(2-Sided) 95%; -60.4 to 1.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

17. Secondary Outcome

Title	Mean Change in Choroidal Neovascularization (CNV) Lesion Size as Assessed by Fluorescein Angiography (FA) From Baseline to Week 24 - LOCF
Description	CNV area values measured in square millimeters, each disc area is equivalent to 2.54 mm^2 on the retina; lower values represent better outcomes
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aflibercept Injection First, Then Aflibercept or Sham	Sham Treatment First, Then Aflibercept Injection or Sham
Arm/Group Description	Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Measure Participants	90	31
Mean (Standard Deviation) [Disc areas]	-0.2233 (0.3195)	0.3007 (0.4383)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aflibercept Injection First, Then Aflibercept or Sham, Sham Treatment First, Then Aflibercept Injection or Sham
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference in least square means
	Estimated Value	-0.4808
	Confidence Interval	(2-Sided) 95%; -0.5990 to -0.3626
	Parameter Dispersion	Type: Value:
	Estimation Comments

18. Secondary Outcome

Title	Mean Change in Choroidal Neovascularization (CNV) Lesion Size as Assessed by Fluorescein Angiography (FA) From Baseline to Week 48 - LOCF
Description	CNV area values measured in square millimeters, each disc area is equivalent to 2.54 mm^2 on the retina; lower values represent better outcomes
Time Frame	Baseline, Week 48

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aflibercept Injection First, Then Aflibercept or Sham	Sham Treatment First, Then Aflibercept Injection or Sham
Arm/Group Description	Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Measure Participants	90	31
Mean (Standard Deviation) [Disc areas]	-0.1995 (0.4281)	-0.0111 (0.4031)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aflibercept Injection First, Then Aflibercept or Sham, Sham Treatment First, Then Aflibercept Injection or Sham
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0256
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference in least square means
	Estimated Value	-0.1346
	Confidence Interval	(2-Sided) 95%; -0.2525 to -0.0167
	Parameter Dispersion	Type: Value:
	Estimation Comments

19. Secondary Outcome

Title	Mean Change in European Five-dimensional Health Scale (EQ-5D) Score From Baseline to Week 24 - LOCF
Description	EQ-5D is a quality of life questionnaire based on a scale from -0.594 (worst) to 1.00 (best).
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aflibercept Injection First, Then Aflibercept or Sham	Sham Treatment First, Then Aflibercept Injection or Sham
Arm/Group Description	Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Measure Participants	90	31
Mean (Standard Deviation) [Scores on a scale]	0.0187 (0.1749)	0.0341 (0.1723)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aflibercept Injection First, Then Aflibercept or Sham, Sham Treatment First, Then Aflibercept Injection or Sham
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8690
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference in least square means
	Estimated Value	-0.0045
	Confidence Interval	(2-Sided) 95%; -0.0579 to 0.0490
	Parameter Dispersion	Type: Value:
	Estimation Comments

20. Secondary Outcome

Title	Mean Change in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score From Baseline to Week 24 - LOCF
Description	The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aflibercept Injection First, Then Aflibercept or Sham	Sham Treatment First, Then Aflibercept Injection or Sham
Arm/Group Description	Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Measure Participants	90	31
Mean (Standard Deviation) [Scores on a scale]	3.14 (10.21)	-2.58 (10.07)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aflibercept Injection First, Then Aflibercept or Sham, Sham Treatment First, Then Aflibercept Injection or Sham
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0104
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference of least square means
	Estimated Value	5.21
	Confidence Interval	(2-Sided) 95%; 1.25 to 9.18
	Parameter Dispersion	Type: Value:
	Estimation Comments

21. Secondary Outcome

Title	Percentage of Participants Who Were Withdrawn From Study Drug During the First 24 Weeks
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aflibercept Injection First, Then Aflibercept or Sham	Sham Treatment First, Then Aflibercept Injection or Sham
Arm/Group Description	Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Measure Participants	90	31
Number [Percentage of participants]	6.7 7.4%	19.4 62.6%

22. Secondary Outcome

Title	Mean Change in Area of Leakage From Baseline at Week 24 - LOCF
Description	A negative change from baseline indicates improvement, ie, less leakage.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aflibercept Injection First, Then Aflibercept or Sham	Sham Treatment First, Then Aflibercept Injection or Sham
Arm/Group Description	Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.	Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
Measure Participants	90	31
Mean (Standard Deviation) [Disc areas]	-0.4743 (0.4839)	0.2094 (0.5088)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aflibercept Injection First, Then Aflibercept or Sham, Sham Treatment First, Then Aflibercept Injection or Sham
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Difference in least square means
	Estimated Value	-0.6648
	Confidence Interval	(2-Sided) 95%; -0.8056 to -0.5239
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	From the first study drug injection until 30 days after the last study drug injection at the latest up to week 48.
Arm/Group Title	Aflibercept Injection (Until Week 20)		Sham Treatment (Until Week 20)		Aflibercept Injection (Until Week 44)		Sham Treatment Then Aflibercept Injection (Until Week 44)
Arm/Group Description	Participants received a 2 mg single dose of IAI at baseline (Week 20). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 20 only if the CNV persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met, participant received a sham injection. Participants were observed until week 24. Participants in the safety population were at risk.		Participants received a sham injection every 4 weeks from week 0 through week 20. Participants were observed until week 24. Participants in the safety population were at risk.		Participants who continued the study drug until week 20 were monitored every 4 weeks and received a single 2 mg dose IAI at these visits from week 24 through week 44 only if the CNV persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met, participant received a sham injection. Participants were observed from week 24 until week 48. Participants in the safety population were at risk.		Participants who continued the sham treatment until week 20 were monitored every 4 weeks and received a single 2 mg dose IAI at these visits from week 24 through week 44 only if the CNV persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment were not met, participant received a sham injection. Participants were observed from Week 24 until Week 48. Participants in the safety population were at risk.
All Cause Mortality
	Aflibercept Injection (Until Week 20)		Sham Treatment (Until Week 20)		Aflibercept Injection (Until Week 44)		Sham Treatment Then Aflibercept Injection (Until Week 44)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Aflibercept Injection (Until Week 20)		Sham Treatment (Until Week 20)		Aflibercept Injection (Until Week 44)		Sham Treatment Then Aflibercept Injection (Until Week 44)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/91 (3.3%)		0/31 (0%)		4/91 (4.4%)		0/31 (0%)
Blood and lymphatic system disorders
Idiopathic thrombocytopenic purpura	1/91 (1.1%)		0/31 (0%)		0/91 (0%)		0/31 (0%)
Eye disorders
Choroidal neovascularisation	0/91 (0%)		0/31 (0%)		1/91 (1.1%)		0/31 (0%)
Macular hole	0/91 (0%)		0/31 (0%)		2/91 (2.2%)		0/31 (0%)
Infections and infestations
Pneumonia moraxella	0/91 (0%)		0/31 (0%)		1/91 (1.1%)		0/31 (0%)
Nervous system disorders
Cerebral haemorrhage	1/91 (1.1%)		0/31 (0%)		0/91 (0%)		0/31 (0%)
Psychiatric disorders
Depression	1/91 (1.1%)		0/31 (0%)		0/91 (0%)		0/31 (0%)
Other (Not Including Serious) Adverse Events
	Aflibercept Injection (Until Week 20)		Sham Treatment (Until Week 20)		Aflibercept Injection (Until Week 44)		Sham Treatment Then Aflibercept Injection (Until Week 44)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	30/91 (33%)		8/31 (25.8%)		18/91 (19.8%)		8/31 (25.8%)
Eye disorders
Conjunctival haemorrhage	7/91 (7.7%)		1/31 (3.2%)		7/91 (7.7%)		1/31 (3.2%)
Dry eye	6/91 (6.6%)		1/31 (3.2%)		1/91 (1.1%)		1/31 (3.2%)
Eye pain	6/91 (6.6%)		1/31 (3.2%)		2/91 (2.2%)		1/31 (3.2%)
Posterior capsule opacification	0/91 (0%)		0/31 (0%)		0/91 (0%)		3/31 (9.7%)
Punctate keratitis	4/91 (4.4%)		3/31 (9.7%)		5/91 (5.5%)		3/31 (9.7%)
Gastrointestinal disorders
Nausea	5/91 (5.5%)		0/31 (0%)		3/91 (3.3%)		0/31 (0%)
Infections and infestations
Herpes zoster	0/91 (0%)		2/31 (6.5%)		0/91 (0%)		0/31 (0%)
Nasopharyngitis	9/91 (9.9%)		2/31 (6.5%)		9/91 (9.9%)		2/31 (6.5%)
Nervous system disorders
Headache	6/91 (6.6%)		1/31 (3.2%)		0/91 (0%)		0/31 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.