MACULA: Observational Study Of The Long-Term Effect Of Macugen In Patients With Wet Age-Related Macular Degeneration

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01245387
• Collaborator: (none)
• Enrollment: 1,001
• Duration (Months): 40

Study Details

Study Description

Brief Summary

Long-term observational study to assess the safety, efficacy and quality of life of patients with neovascular age-related macular degeneration (AMD) under Macugen treatment.

Condition or Disease	Intervention/Treatment	Phase
Macular Degeneration; Age-related Macular Degeneration; Neovascular Macular Degeneration	Drug: Pegaptanib

Detailed Description

Ophthalmologists who are experienced in doing intravitreal injections in Germany

Study Design

• Study Type: Observational
• Actual Enrollment: 1001 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Long-Term Non-Interventional Study (AB Study) To Investigate The Efficacy And Safety Of Macugen® In Patients With Neovascular Age-Related Macular Degeneration Under Conditions Of Routine Clinical Practice
• Study Start Date: Aug 1, 2006
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm

Intervention/Treatment

Macugen

Drug: Pegaptanib; Dosage recommendations for MACUGEN took place on the basis of the approved Summary of Product Characteristics (SmPC) and were adjusted solely according to medical practice. MACUGEN® is available as pre-filled syringe containing 0.3 mg MACUGEN® in 90 µL injection solution for intravitreal injection. Macugen injections were documented to reflect the routine clinical practice. Follow-up visits were only carried out and documented if they took place as part of the standard medical treatment for the respective case and were necessary for medical and/or therapeutic reasons.

Outcome Measures

Primary Outcome Measures

1. Visual Acuity (VA) [Baseline, every 6 weeks up to Month 24 or early termination]

   VA measured at each follow-up visit as the number of lines read on a standard eye chart (Snellen or Early Treatment Diabetic Retinopathy Study [EDTRS]) using a 5 meter distance, 1 meter distance, or verifying if participant was able to count fingers, perceive hand motion, or light. Follow-up visits occurred only if considered part of standard medical treatment. The timeframe was as follows: Visit 1: before first injection; Visit 2: first injection; Visit 3: 6 weeks after first injection (second injection).

2. Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25): Overall Composite Score [Baseline, every 6 months up to Month 24 or early termination]

   Participant-reported vision-related functioning and quality of life measured using the 25 item NEI-VFQ-25. Converted scale 0-100 where higher score represented better functioning: General Health: item 1; General Vision: item 2; Ocular Pain: 4,19; Near Vision: 5,6,7; Distance Vision: 8,9,14; Social Functioning: 11,13; Mental Health Activities: 3,21,22,25; Role Difficulties: 17,18; Dependency: 20,23,24; Driving: 15c,16, 16a; Color Vision: 12; Peripheral Vision: 10.

3. Number of Participants With Investigator Assessments of Efficacy [Month 24 or early termination]

   Investigator's categorical assessment of the efficacy of Macugen (pegaptanib) treatment at the final visit or termination of therapy; Categories included Very Good, Good, Moderate, and Poor.

4. Lesion Size (Number of Optic Disc Areas) [Baseline, every 6 weeks up to Month 24 or early termination]

   Lesion size measured by Investigator after each injection as part of standard of care (SOC), using standard clinical methods practiced (fluorescein or indocyanine green angiography); Reported as the number of optic-disk areas, each of which were 2.54 millimeters squared (mm^2). Lesion size included choroidal neovascularization, exudation area, and hemorrhage, if present. The timeframe was as follows: Visit 1: before first injection; Visit 3: 6 weeks after first injection (second injection).

5. Number of Participants With a Change in Activity of Neovascular Membrane at Week 6 [Week 6]

   Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 3, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.

6. Number of Participants With a Change in Activity of Neovascular Membrane at Week 12 [Week 12]

   Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 4, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.

7. Number of Participants With a Change in Activity of Neovascular Membrane at Week 18 [Week 18]

   Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 5, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.

8. Number of Participants With a Change in Activity of Neovascular Membrane at Week 24 [Week 24]

   Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 6, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.

9. Number of Participants With a Change in Activity of Neovascular Membrane at Week 30 [Week 30]

   Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 7, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.

10. Number of Participants With a Change in Activity of Neovascular Membrane at Week 36 [Week 36]

    Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 8, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.

11. Number of Participants With a Change in Activity of Neovascular Membrane at Week 42 [Week 42]

    Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 9, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.

12. Number of Participants With a Change in Activity of Neovascular Membrane at Week 48 [Week 48]

    Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 10, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.

13. Number of Participants With a Change in Activity of Neovascular Membrane at Week 54 [Week 54]

    Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 11, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.

14. Number of Participants With a Change in Activity of Neovascular Membrane at Week 60 [Week 60]

    Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 12, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.

15. Number of Participants With a Change in Activity of Neovascular Membrane at Week 66 [Week 66]

    Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 13, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.

16. Number of Participants With a Change in Activity of Neovascular Membrane at Week 72 [Week 72]

    Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 14, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.

17. Number of Participants With a Change in Activity of Neovascular Membrane at Last Visit [Month 24 or early termination]

    Neovascular membrane activity (measured by leakage) assessed by Investigator at the Last Visit, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity. Last Visit: last available postbaseline value.

18. Number of Participants With Pigment Epithelial Detachment (PED) at Baseline [Baseline]

    PED assessed by Investigator at baseline as part of SOC for participants with age-related macular degeneration; Standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.

19. Number of Participants With PED at Week 6 [Week 6]

    PED assessed by Investigator at Visit 3, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.

20. Number of Participants With PED at Week 12 [Week 12]

    PED assessed by Investigator at Visit 4, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.

21. Number of Participants With PED at Week 18 [Week 18]

    PED assessed by Investigator at Visit 5, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.

22. Number of Participants With PED at Week 24 [Week 24]

    PED assessed by Investigator at Visit 6, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.

23. Number of Participants With PED at Week 30 [Week 30]

    PED assessed by Investigator at Visit 7, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.

24. Number of Participants With PED at Week 36 [Week 36]

    PED assessed by Investigator at Visit 8, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.

25. Number of Participants With PED at Week 42 [Week 42]

    PED assessed by Investigator at Visit 9, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.

26. Number of Participants With PED at Week 48 [Week 48]

    PED assessed by Investigator at Visit 10, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.

27. Number of Participants With PED at Week 54 [Week 54]

    PED assessed by Investigator Visit 11, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.

28. Number of Participants With PED at Last Visit [Month 24 or early termination]

    PED assessed by Investigator at Last Visit, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent. Last Visit: last available postbaseline value.

29. Central Retinal Thickness [Baseline, every 6 weeks up to Month 24 or early termination]

    Central retinal thickness assessed by Investigator every 6 weeks, as part of SOC, using standard clinical methods practiced (optical coherence tomography) and reported as mean central retinal thickness. The timeframe was as follows: Visit 1: before first injection; Visit 3: 6 weeks after first injection (second injection).

30. Number of Participants With Angiographic Subtype Reported at Baseline [Baseline]

    Angiographic subtype assessed by Investigator at Baseline, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).

31. Number of Participants With Angiographic Subtype Reported at Week 6 [Week 6]

    Angiographic subtype assessed by Investigator at Visit 3, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).

32. Number of Participants With Angiographic Subtype Reported at Week 12 [Week 12]

    Angiographic subtype assessed by Investigator at Visit 4, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).

33. Number of Participants With Angiographic Subtype Reported at Week 18 [Week 18]

    Angiographic subtype assessed by Investigator at Visit 5, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).

34. Number of Participants With Angiographic Subtype Reported at Week 24 [Week 24]

    Angiographic subtype assessed by Investigator at Visit 6, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).

35. Number of Participants With Angiographic Subtype Reported at Week 30 [Week 30]

    Angiographic subtype assessed by Investigator at Visit 7, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent (%) classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).

36. Number of Participants With Angiographic Subtype Reported at Week 36 [Week 36]

    Angiographic subtype assessed by Investigator at Visit 8, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).

37. Number of Participants With Angiographic Subtype Reported at Week 42 [Week 42]

    Angiographic subtype assessed by Investigator at Visit 9, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).

38. Number of Participants With Angiographic Subtype Reported at Week 48 [Week 48]

    Angiographic subtype assessed by Investigator at Visit 10, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).

39. Number of Participants With Angiographic Subtype Reported at Week 54 [Week 54]

    Angiographic subtype assessed by Investigator at Visit 11, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).

40. Number of Participants With Angiographic Subtype Reported at Last Visit [Month 24 or early termination]

    Angiographic subtype assessed by Investigator at the Last Visit, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic). Last Visit: last available postbaseline value.

Other Outcome Measures

1. Time to First Adverse Event (AE) [Baseline up to Month 24 or early termination]

   Time to first AE during the study evaluated by Kaplan-Meier Product-limit methods. AE:any untoward medical occurrence in a participant administered a product or medical device in the context of study; the event need not necessarily have a causal relationship with the treatment or usage.

2. Number of Participants With Complications Associated With Injection [Baseline up to Month 24 or early termination]

   Complications associated with injection during the study with onset at or after date of first injection was recorded by the Investigator.

3. Treatment Tolerability [Month 24 or early termination]

   Investigator's overall evaluation of tolerability; Categories included: Very Good, Good, Moderate, and Poor.

4. Intraocular Pressure (IOP) [Baseline, every 6 weeks up to Month 24 or early termination]

   IOP measured at each visit using either applanation tonometry or non-contact before intraviterial injection, reported as pre-dose pressure of treated eye in millimeters of mercury (mmHg). The timeframe was as follows: Visit 1: IOP before any injection; Visit 2: IOP before first injection; Visit 3: IOP before second injection.

5. Change in IOP Between Predose and Postdose Assessment [Baseline, every 6 weeks up to Month 24 or early termination]

   IOP measured at each visit using either applanation tonometry or non-contact before and after intraviterial injection. Change in IOP equals postdose IOP minus predose IOP.

6. IOP Mean Difference (Within a Participant) [Baseline, every 6 weeks up to Month 24 or early termination]

   Average predose minus postdose mean difference in IOP within a participant

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• patients with neovascular age-related macular degeneration

Exclusion Criteria:

• none

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01245387
• Other Study ID Numbers: A5751021
• First Posted: Nov 22, 2010
• Last Update Posted: Jan 13, 2011
• Last Verified: Jan 1, 2011

• Keywords provided by , ,: prospective; observational; Phase 4; non-interventional; open-label
• Additional relevant MeSH terms: Macular Degeneration

Study Results

Participant Flow

Pre-assignment Detail	This observational study did not define endpoints as primary or secondary. All endpoints arbitrarily assigned as primary for reporting results.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Period Title: Overall Study
STARTED	1001
COMPLETED	188
NOT COMPLETED	813

Baseline Characteristics

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Overall Participants	1001
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	77.4 (7.8)
Sex/Gender, Customized (participants) [Number]
Female	666 66.5%
Male	330 33%
Unspecified	5 0.5%

Outcome Measures

1. Primary Outcome

Title	Visual Acuity (VA)
Description	VA measured at each follow-up visit as the number of lines read on a standard eye chart (Snellen or Early Treatment Diabetic Retinopathy Study [EDTRS]) using a 5 meter distance, 1 meter distance, or verifying if participant was able to count fingers, perceive hand motion, or light. Follow-up visits occurred only if considered part of standard medical treatment. The timeframe was as follows: Visit 1: before first injection; Visit 2: first injection; Visit 3: 6 weeks after first injection (second injection).
Time Frame	Baseline, every 6 weeks up to Month 24 or early termination

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS):participants who received at least 1 Macugen (pegaptanib) injection and had at least 1 VA measurement postbaseline. Participants with light perception or no light perception any time during study were excluded from FAS; N=participants with evaluable data; Last Visit: last available postbaseline value.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	812
Visit 1, Baseline (N=812)	8.51 (5.03)
Visit 2, Week 0, first injection (N=812)	8.72 (5.19)
Visit 3, Week 6 (N=785)	8.67 (4.90)
Visit 4, Week 12 (N=684)	8.93 (4.97)
Visit 5, Week 18 (N=537)	9.06 (4.81)
Visit 6, Week 24 (N=253)	8.83 (5.32)
Visit 7, Week 30 (N=203)	8.60 (4.69)
Visit 8, Week 36 (N=133)	8.07 (3.81)
Visit 9, Week 42 (N=86)	8.35 (3.42)
Visit 10, Week 48 (N=54)	8.33 (3.44)
Visit 11, Week 54 (N=11)	8.86 (3.30)
Visit 12, Week 60 (N=6)	9.34 (3.33)
Visit 13, Week 66 (N=4)	8.49 (3.01)
Visit 14, Week 72 (N=2)	7.61 (3.37)
Last Visit (N=786)	9.26 (5.24)

2. Primary Outcome

Title	Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25): Overall Composite Score
Description	Participant-reported vision-related functioning and quality of life measured using the 25 item NEI-VFQ-25. Converted scale 0-100 where higher score represented better functioning: General Health: item 1; General Vision: item 2; Ocular Pain: 4,19; Near Vision: 5,6,7; Distance Vision: 8,9,14; Social Functioning: 11,13; Mental Health Activities: 3,21,22,25; Role Difficulties: 17,18; Dependency: 20,23,24; Driving: 15c,16, 16a; Color Vision: 12; Peripheral Vision: 10.
Time Frame	Baseline, every 6 months up to Month 24 or early termination

Outcome Measure Data

Analysis Population Description

FAS; N=number of participants with evaluable data; Last Visit: last available postbaseline value.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	485
Visit 1, Baseline (N=485)	54.05 (23.50)
Visit 2, Month 6 (N=219)	55.56 (22.17)
Visit 3, Month 12 (N=167)	57.13 (21.60)
Visit 4, Month 18 (N=135)	56.95 (20.58)
Visit 5, Month 24 (N=338)	56.09 (23.73)
Last Visit (N=410)	54.90 (23.86)

3. Primary Outcome

Title	Number of Participants With Investigator Assessments of Efficacy
Description	Investigator's categorical assessment of the efficacy of Macugen (pegaptanib) treatment at the final visit or termination of therapy; Categories included Very Good, Good, Moderate, and Poor.
Time Frame	Month 24 or early termination

Outcome Measure Data

Analysis Population Description

FAS; N = number of participants with evaluable data.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	604
Very Good	36 3.6%
Good	226 22.6%
Moderate	168 16.8%
Poor	174 17.4%

4. Primary Outcome

Title	Lesion Size (Number of Optic Disc Areas)
Description	Lesion size measured by Investigator after each injection as part of standard of care (SOC), using standard clinical methods practiced (fluorescein or indocyanine green angiography); Reported as the number of optic-disk areas, each of which were 2.54 millimeters squared (mm^2). Lesion size included choroidal neovascularization, exudation area, and hemorrhage, if present. The timeframe was as follows: Visit 1: before first injection; Visit 3: 6 weeks after first injection (second injection).
Time Frame	Baseline, every 6 weeks up to Month 24 or early termination

Outcome Measure Data

Analysis Population Description

FAS; N=number of participants with evaluable data; Last Visit: last available postbaseline value.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	712
Visit 1, Baseline (N=712)	2.4 (1.6)
Visit 3, Week 6 (N=190)	2.1 (1.2)
Visit 4, Week 12 (N=173)	2.3 (1.7)
Visit 5, Week 18 (N=316)	2.2 (2.0)
Visit 6, Week 24 (N=45)	2.3 (1.3)
Visit 7, Week 30 (N=45)	3.2 (2.1)
Visit 8, Week 36 (N=78)	2.8 (2.0)
Visit 9, Week 42 (N=15)	2.5 (1.3)
Visit 10, Week 48 (N=9)	2.5 (1.4)
Visit 11, Week 54 (N=6)	2.3 (0.8)
Visit 12, Week 60 (N=2)	2.0 (1.4)
Visit 13, Week 66 (N=3)	0.8 (0.3)
Last Visit (N=513)	2.5 (2.1)

5. Primary Outcome

Title	Number of Participants With a Change in Activity of Neovascular Membrane at Week 6
Description	Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 3, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Time Frame	Week 6

Outcome Measure Data

Analysis Population Description

FAS; N=number of participants with evaluable data.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	190
Increased	28 2.8%
Unchanged	74 7.4%
Decreased	88 8.8%

6. Primary Outcome

Title	Number of Participants With a Change in Activity of Neovascular Membrane at Week 12
Description	Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 4, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

FAS; N=number of participants with evaluable data.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	173
Increased	22 2.2%
Unchanged	66 6.6%
Decreased	85 8.5%

7. Primary Outcome

Title	Number of Participants With a Change in Activity of Neovascular Membrane at Week 18
Description	Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 5, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Time Frame	Week 18

Outcome Measure Data

Analysis Population Description

FAS; N=number of participants with evaluable data.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	316
Increased	57 5.7%
Unchanged	83 8.3%
Decreased	176 17.6%

8. Primary Outcome

Title	Number of Participants With a Change in Activity of Neovascular Membrane at Week 24
Description	Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 6, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

FAS; N=number of participants with evaluable data.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	46
Increased	13 1.3%
Unchanged	15 1.5%
Decreased	18 1.8%

9. Primary Outcome

Title	Number of Participants With a Change in Activity of Neovascular Membrane at Week 30
Description	Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 7, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Time Frame	Week 30

Outcome Measure Data

Analysis Population Description

FAS; N=number of participants with evaluable data.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	45
Increased	6 0.6%
Unchanged	15 1.5%
Decreased	24 2.4%

10. Primary Outcome

Title	Number of Participants With a Change in Activity of Neovascular Membrane at Week 36
Description	Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 8, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Time Frame	Week 36

Outcome Measure Data

Analysis Population Description

FAS; N=number of participants with evaluable data.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	78
Increased	11 1.1%
Unchanged	21 2.1%
Decreased	46 4.6%

11. Primary Outcome

Title	Number of Participants With a Change in Activity of Neovascular Membrane at Week 42
Description	Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 9, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Time Frame	Week 42

Outcome Measure Data

Analysis Population Description

FAS; N=number of participants with evaluable data.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	15
Increased	3 0.3%
Unchanged	6 0.6%
Decreased	6 0.6%

12. Primary Outcome

Title	Number of Participants With a Change in Activity of Neovascular Membrane at Week 48
Description	Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 10, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

FAS; N=number of participants with evaluable data.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	10
Increased	2 0.2%
Unchanged	3 0.3%
Decreased	5 0.5%

13. Primary Outcome

Title	Number of Participants With a Change in Activity of Neovascular Membrane at Week 54
Description	Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 11, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Time Frame	Week 54

Outcome Measure Data

Analysis Population Description

FAS; N=number of participants with evaluable data.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	6
Increased	0 0%
Unchanged	2 0.2%
Decreased	4 0.4%

14. Primary Outcome

Title	Number of Participants With a Change in Activity of Neovascular Membrane at Week 60
Description	Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 12, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Time Frame	Week 60

Outcome Measure Data

Analysis Population Description

FAS; N=number of participants with evaluable data.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	2
Increased	1 0.1%
Unchanged	0 0%
Decreased	1 0.1%

15. Primary Outcome

Title	Number of Participants With a Change in Activity of Neovascular Membrane at Week 66
Description	Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 13, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Time Frame	Week 66

Outcome Measure Data

Analysis Population Description

FAS; N=number of participants with evaluable data.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	3
Increased	0 0%
Unchanged	1 0.1%
Decreased	2 0.2%

16. Primary Outcome

Title	Number of Participants With a Change in Activity of Neovascular Membrane at Week 72
Description	Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 14, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Time Frame	Week 72

Outcome Measure Data

Analysis Population Description

FAS; N=number of participants with evaluable data.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	1
Increased	0 0%
Unchanged	0 0%
Decreased	1 0.1%

17. Primary Outcome

Title	Number of Participants With a Change in Activity of Neovascular Membrane at Last Visit
Description	Neovascular membrane activity (measured by leakage) assessed by Investigator at the Last Visit, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity. Last Visit: last available postbaseline value.
Time Frame	Month 24 or early termination

Outcome Measure Data

Analysis Population Description

FAS; N=number of participants with evaluable data.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	514
Increased	101 10.1%
Unchanged	170 17%
Decreased	243 24.3%

18. Primary Outcome

Title	Number of Participants With Pigment Epithelial Detachment (PED) at Baseline
Description	PED assessed by Investigator at baseline as part of SOC for participants with age-related macular degeneration; Standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

FAS; N=number of participants with evaluable data.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	713
Present	240 24%
Absent	473 47.3%

19. Primary Outcome

Title	Number of Participants With PED at Week 6
Description	PED assessed by Investigator at Visit 3, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Time Frame	Week 6

Outcome Measure Data

Analysis Population Description

FAS; N=number of participants with evaluable data.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	188
Present	46 4.6%
Absent	142 14.2%

20. Primary Outcome

Title	Number of Participants With PED at Week 12
Description	PED assessed by Investigator at Visit 4, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

FAS; N=number of participants with evaluable data.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	169
Present	32 3.2%
Absent	137 13.7%

21. Primary Outcome

Title	Number of Participants With PED at Week 18
Description	PED assessed by Investigator at Visit 5, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Time Frame	Week 18

Outcome Measure Data

Analysis Population Description

FAS; N=number of participants with evaluable data.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	313
Present	45 4.5%
Absent	268 26.8%

22. Primary Outcome

Title	Number of Participants With PED at Week 24
Description	PED assessed by Investigator at Visit 6, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

FAS; N=number of participants with evaluable data.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	45
Present	7 0.7%
Absent	38 3.8%

23. Primary Outcome

Title	Number of Participants With PED at Week 30
Description	PED assessed by Investigator at Visit 7, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Time Frame	Week 30

Outcome Measure Data

Analysis Population Description

FAS; N=number of participants with evaluable data.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	44
Present	11 1.1%
Absent	33 3.3%

24. Primary Outcome

Title	Number of Participants With PED at Week 36
Description	PED assessed by Investigator at Visit 8, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Time Frame	Week 36

Outcome Measure Data

Analysis Population Description

FAS; N=number of participants with evaluable data.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	77
Present	11 1.1%
Absent	66 6.6%

25. Primary Outcome

Title	Number of Participants With PED at Week 42
Description	PED assessed by Investigator at Visit 9, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Time Frame	Week 42

Outcome Measure Data

Analysis Population Description

FAS; N=number of participants with evaluable data.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	15
Present	3 0.3%
Absent	12 1.2%

26. Primary Outcome

Title	Number of Participants With PED at Week 48
Description	PED assessed by Investigator at Visit 10, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

FAS; N=number of participants with evaluable data.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	10
Present	6 0.6%
Absent	4 0.4%

27. Primary Outcome

Title	Number of Participants With PED at Week 54
Description	PED assessed by Investigator Visit 11, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Time Frame	Week 54

Outcome Measure Data

Analysis Population Description

FAS; N=number of participants with evaluable data.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	6
Present	1 0.1%
Absent	5 0.5%

28. Primary Outcome

Title	Number of Participants With PED at Last Visit
Description	PED assessed by Investigator at Last Visit, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent. Last Visit: last available postbaseline value.
Time Frame	Month 24 or early termination

Outcome Measure Data

Analysis Population Description

FAS; N=number of participants with evaluable data.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	509
Present	87 8.7%
Absent	422 42.2%

29. Primary Outcome

Title	Central Retinal Thickness
Description	Central retinal thickness assessed by Investigator every 6 weeks, as part of SOC, using standard clinical methods practiced (optical coherence tomography) and reported as mean central retinal thickness. The timeframe was as follows: Visit 1: before first injection; Visit 3: 6 weeks after first injection (second injection).
Time Frame	Baseline, every 6 weeks up to Month 24 or early termination

Outcome Measure Data

Analysis Population Description

FAS; N=number of participants with evaluable data; Last Visit: last available postbaseline value.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	316
Visit 1, Baseline (N=316)	309.2 (105.9)
Visit 3, Week 6 (N=224)	305.8 (111.3)
Visit 4, Week 12 (N=173)	307.3 (122.9)
Visit 5, Week 18 (N=205)	297.8 (145.0)
Visit 6, Week 24 (N=33)	328.9 (180.5)
Visit 7, Week 30 (N=26)	272.7 (67.4)
Visit 8, Week 36 (N=27)	319.6 (118.7)
Visit 9, Week 42 (N=13)	252.9 (88.8)
Visit 10, Week 48 (N=3)	312.0 (133.5)
Last Visit (N=311)	295.2 (138.5)

30. Primary Outcome

Title	Number of Participants With Angiographic Subtype Reported at Baseline
Description	Angiographic subtype assessed by Investigator at Baseline, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

FAS; N=number of participants with evaluable data.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	716
unclear	76 7.6%
occult	363 36.3%
minimally classic	113 11.3%
predominantly classic	138 13.8%
pure classic	26 2.6%

31. Primary Outcome

Title	Number of Participants With Angiographic Subtype Reported at Week 6
Description	Angiographic subtype assessed by Investigator at Visit 3, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Time Frame	Week 6

Outcome Measure Data

Analysis Population Description

FAS;N=number of participants with evaluable data.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	190
unclear	29 2.9%
occult	81 8.1%
minimally classic	21 2.1%
predominantly classic	56 5.6%
pure classic	3 0.3%

32. Primary Outcome

Title	Number of Participants With Angiographic Subtype Reported at Week 12
Description	Angiographic subtype assessed by Investigator at Visit 4, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

FAS; N=number of participants with evaluable data.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	173
unclear	29 2.9%
occult	71 7.1%
minimally classic	21 2.1%
predominantly classic	50 5%
pure classic	2 0.2%

33. Primary Outcome

Title	Number of Participants With Angiographic Subtype Reported at Week 18
Description	Angiographic subtype assessed by Investigator at Visit 5, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Time Frame	Week 18

Outcome Measure Data

Analysis Population Description

FAS; N=number of participants with evaluable data.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	316
unclear	68 6.8%
occult	140 14%
minimally classic	70 7%
predominantly classic	30 3%
pure classic	8 0.8%

34. Primary Outcome

Title	Number of Participants With Angiographic Subtype Reported at Week 24
Description	Angiographic subtype assessed by Investigator at Visit 6, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent [%] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

FAS; N=number of participants with evaluable data.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	45
unclear	7 0.7%
occult	26 2.6%
minimally classic	5 0.5%
predominantly classic	5 0.5%
pure classic	2 0.2%

35. Primary Outcome

Title	Number of Participants With Angiographic Subtype Reported at Week 30
Description	Angiographic subtype assessed by Investigator at Visit 7, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent (%) classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Time Frame	Week 30

Outcome Measure Data

Analysis Population Description

FAS; N=number of participants with evaluable data.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	45
unclear	10 1%
occult	23 2.3%
minimally classic	8 0.8%
predominantly classic	3 0.3%
pure classic	1 0.1%

36. Primary Outcome

Title	Number of Participants With Angiographic Subtype Reported at Week 36
Description	Angiographic subtype assessed by Investigator at Visit 8, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Time Frame	Week 36

Outcome Measure Data

Analysis Population Description

FAS; N=number of participants with evaluable data.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	78
unclear	5 0.5%
occult	37 3.7%
minimally classic	30 3%
predominantly classic	3 0.3%
pure classic	3 0.3%

37. Primary Outcome

Title	Number of Participants With Angiographic Subtype Reported at Week 42
Description	Angiographic subtype assessed by Investigator at Visit 9, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Time Frame	Week 42

Outcome Measure Data

Analysis Population Description

FAS; N=number of participants with evaluable data.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	15
unclear	3 0.3%
occult	10 1%
minimally classic	1 0.1%
predominantly classic	0 0%
pure classic	1 0.1%

38. Primary Outcome

Title	Number of Participants With Angiographic Subtype Reported at Week 48
Description	Angiographic subtype assessed by Investigator at Visit 10, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

FAS; N=number of participants with evaluable data.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	10
unclear	0 0%
occult	7 0.7%
minimally classic	3 0.3%
predominantly classic	0 0%
pure classic	0 0%

39. Primary Outcome

Title	Number of Participants With Angiographic Subtype Reported at Week 54
Description	Angiographic subtype assessed by Investigator at Visit 11, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Time Frame	Week 54

Outcome Measure Data

Analysis Population Description

FAS; N=number of participants with evaluable data.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	6
unclear	0 0%
occult	3 0.3%
minimally classic	3 0.3%
predominantly classic	0 0%
pure classic	0 0%

40. Primary Outcome

Title	Number of Participants With Angiographic Subtype Reported at Last Visit
Description	Angiographic subtype assessed by Investigator at the Last Visit, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic). Last Visit: last available postbaseline value.
Time Frame	Month 24 or early termination

Outcome Measure Data

Analysis Population Description

FAS; N=number of participants with evaluable data.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	514
unclear	105 10.5%
occult	251 25.1%
minimally classic	88 8.8%
predominantly classic	58 5.8%
pure classic	12 1.2%

41. Other Pre-specified Outcome

Title	Time to First Adverse Event (AE)
Description	Time to first AE during the study evaluated by Kaplan-Meier Product-limit methods. AE:any untoward medical occurrence in a participant administered a product or medical device in the context of study; the event need not necessarily have a causal relationship with the treatment or usage.
Time Frame	Baseline up to Month 24 or early termination

Outcome Measure Data

Analysis Population Description

Safety Set: all participants who received at least 1 Macugen (pegaptanib) injection and provided data post baseline. Data not analyzed due to low number of AEs.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	0

42. Other Pre-specified Outcome

Title	Number of Participants With Complications Associated With Injection
Description	Complications associated with injection during the study with onset at or after date of first injection was recorded by the Investigator.
Time Frame	Baseline up to Month 24 or early termination

Outcome Measure Data

Analysis Population Description

Safety Set; N=number of participants with evaluable data.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	815
Yes	1 0.1%
No	814 81.3%

43. Other Pre-specified Outcome

Title	Treatment Tolerability
Description	Investigator's overall evaluation of tolerability; Categories included: Very Good, Good, Moderate, and Poor.
Time Frame	Month 24 or early termination

Outcome Measure Data

Analysis Population Description

Safety Set; N=number of participants with evaluable data.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	589
Very Good	182 18.2%
Good	367 36.7%
Moderate	35 3.5%
Poor	5 0.5%

44. Other Pre-specified Outcome

Title	Intraocular Pressure (IOP)
Description	IOP measured at each visit using either applanation tonometry or non-contact before intraviterial injection, reported as pre-dose pressure of treated eye in millimeters of mercury (mmHg). The timeframe was as follows: Visit 1: IOP before any injection; Visit 2: IOP before first injection; Visit 3: IOP before second injection.
Time Frame	Baseline, every 6 weeks up to Month 24 or early termination

Outcome Measure Data

Analysis Population Description

Safety Set; N=number of participants with evaluable data; Last Visit: last available postbaseline value.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	809
Visit 1, Baseline (N=809)	15.7 (2.8)
Visit 2, Week 0 (N=568)	15.7 (3.0)
Visit 3, Week 6 (N=772)	15.7 (3.2)
Visit 4, Week 12 (N=661)	15.8 (3.1)
Visit 5, Week 18 (N=505)	15.9 (3.1)
Visit 6, Week 24 (N=237)	15.5 (2.8)
Visit 7, Week 30 (N=190)	15.5 (2.6)
Visit 8, Week 36 (N=123)	15.8 (2.3)
Visit 9, Week 42 (N=80)	15.4 (2.0)
Visit 10, Week 48 (N=53)	15.7 (2.3)
Visit 11, Week 54 (N=11)	16.3 (2.9)
Visit 12, Week 60 (N=6)	15.3 (4.0)
Visit 13, Week 66 (N=4)	18.0 (2.3)
Visit 14, Week 72 (N=2)	17.0 (1.4)
Last Visit (N=776)	15.6 (3.0)

45. Other Pre-specified Outcome

Title	Change in IOP Between Predose and Postdose Assessment
Description	IOP measured at each visit using either applanation tonometry or non-contact before and after intraviterial injection. Change in IOP equals postdose IOP minus predose IOP.
Time Frame	Baseline, every 6 weeks up to Month 24 or early termination

Outcome Measure Data

Analysis Population Description

Safety Set; N=number of participants with evaluable data; Last Visit: last available postbaseline value.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	718
Visit 2, Week 0 (N=559)	1.3 (3.7)
Visit 3, Week 6 (N=704)	1.3 (4.1)
Visit 4, Week 12 (N=600)	1.3 (3.8)
Visit 5, Week 18 (N=240)	1.4 (3.7)
Visit 6, Week 24 (N=210)	1.5 (3.3)
Visit 7, Week 30 (N=158)	2.4 (4.9)
Visit 8, Week 36 (N=90)	1.8 (2.5)
Visit 9, Week 42 (N=63)	2.2 (2.8)
Visit 10, Week 48 (N=48)	2.3 (2.1)
Visit 11, Week 54 (n=7)	1.3 (1.7)
Visit 12, Week 60 (N=4)	1.3 (6.3)
Visit 13, Week 66 (N=2)	-2.0 (4.2)
Last Visit (N=718)	1.4 (3.9)

46. Other Pre-specified Outcome

Title	IOP Mean Difference (Within a Participant)
Description	Average predose minus postdose mean difference in IOP within a participant
Time Frame	Baseline, every 6 weeks up to Month 24 or early termination

Outcome Measure Data

Analysis Population Description

Safety Set; N=number of participants with evaluable data.

Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
Measure Participants	763
Mean (Standard Deviation) [mmHg]	1.3 (2.9)

Adverse Events

Adverse Event Reporting Description	The Safety population (N=816) is less than total number of participants in study (1001) because some participants had a baseline visit but no injection or no data post baseline. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events.
Arm/Group Title	Macugen
Arm/Group Description	Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
All Cause Mortality
	Macugen
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Macugen
	Affected / at Risk (%)	# Events
Total	16/816 (2%)
Cardiac disorders
Myocardial infarction	2/816 (0.2%)
Atrial fibrillation	1/816 (0.1%)
Cardiac failure	1/816 (0.1%)
Coronary artery disease	1/816 (0.1%)
Eye disorders
Retinal haemorrhage	3/816 (0.4%)
Choroidal neovascularisation	1/816 (0.1%)
Retinal detachment	1/816 (0.1%)
Retinal tear	1/816 (0.1%)
Gastrointestinal disorders
Nausea	1/816 (0.1%)
Infections and infestations
Endophthalmitis	4/816 (0.5%)
Sepsis	1/816 (0.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer	1/816 (0.1%)
Renal cancer	1/816 (0.1%)
Nervous system disorders
Cerebrovascular accident	3/816 (0.4%)
Other (Not Including Serious) Adverse Events
	Macugen
	Affected / at Risk (%)	# Events
Total	12/816 (1.5%)
Eye disorders
Visual acuity reduced	6/816 (0.7%)
Retinal haemorrhage	1/816 (0.1%)
Choroidal neovascularisation	1/816 (0.1%)
Retinal detachment	1/816 (0.1%)
Detachment of retinal pigment epithelium	1/816 (0.1%)
Glaucoma	1/816 (0.1%)
Subretinal fibrosis	1/816 (0.1%)
Vitreous haemorrhage	1/816 (0.1%)
General disorders
Injection site reaction	1/816 (0.1%)
Infections and infestations
Endophthalmitis	1/816 (0.1%)
Investigations
Intraocular pressure increased	2/816 (0.2%)
Paracentesis eye	1/816 (0.1%)
Surgical and medical procedures
Eye operation	1/816 (0.1%)

Limitations/Caveats

Time to first AE not estimated due to insufficient number of events. Visit numbers for NEI-VFQ-25 deviated from numbering used in other analyses; it represents the sequence number of questionaries administered (Visit 1=first assessment, etc.).

More Information

Certain Agreements

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

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.