Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO)
Sponsor
Regeneron Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00943072
Collaborator
Bayer (Industry)
189
61
2
33
3.1
0.1
Study Details
Study Description
Brief Summary
This is a phase 3 study to determine the efficacy of VEGF Trap-Eye injected into the eye on vision function in subjects with macular edema as a consequence of central retinal vein occlusion.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
189 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double Masked, Controlled Phase 3 Study of the Efficacy, Safety, and Tolerability of Repeated Intravitreal Administration of Vascular Endothelial Growth Factor Trap-Eye in Subjects With Macular Edema Secondary to Central Retinal Vein Occlusion
Study Start Date
:
Jul 1, 2009
Actual Primary Completion Date
:
Oct 1, 2010
Actual Study Completion Date
:
Apr 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: VEGF Trap-Eye Monthly IVT injection of VEGF Trap-Eye 2.0 mg until Week 24 Primary Endpoint |
Biological: VEGF Trap-Eye 2.0mg
Monthly intravitreal injection out to the Week 24 Primary endpoint
|
| Sham Comparator: Sham Monthly Sham IVT injection until Week 24 Primary Endpoint |
Drug: Sham
Monthly sham intravitreal injection out to Week 24 Primary Endpoint
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Who Gained at Least 15 Letters in BCVA at Week 24 as Measured by ETDRS Letter Score [Baseline and at Week 24]
Percentage values indicate the number of subjects in each arm who were able to read an additional 15 letters or more at Week 24 compared to baseline. Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 24 letters (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.
Secondary Outcome Measures
- Change From Baseline in BCVA as Measured by ETDRS Letter Score at Week 24 - Last Observation Carried Forward (LOCF) [Baseline and at Week 24]
Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.
- Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF [Baseline and at Week 24]
- Percentage of Participants Progressing to Any of the Following: Anterior Segment Neovascularization, New Vessels of the Disc (NVD) or New Vessels Elsewhere (NVE) During the First 24 Weeks [Baseline to Week 24]
- Change From Baseline in the NEI VFQ-25 in Total Score at Week 24 (LOCF) [Baseline and at Week 24]
The NEI VFQ-25 assesses visual function and quality of life. 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Subjects at least 18 years of age with center-involved macular edema secondary to CRVO with mean central retinal thickness ≥ 250 μm on OCT
-
ETDRS best corrected visual acuity of 20/40 to 20/320 (73 to 24 letters) in the study eye
Exclusion Criteria:
-
Previous treatment with anti-angiogenic drugs in the study eye (Pegaptanib sodium,anecortave acetate, bevacizumab, ranibizumab, etc.)
-
Prior panretinal laser photocoagulation or macular laser photocoagulation in the study eye
-
CRVO disease duration > 9 months from date of diagnosis
-
Previous use of intraocular corticosteroids in the study eye or use of periocular corticosteroids in the study eye within the 3 months prior to Day 1
-
Iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in either the study eye or fellow eye
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Phoenix | Arizona | United States | 85014 | |
| 2 | Phoenix | Arizona | United States | 85020 | |
| 3 | Tucson | Arizona | United States | 85704 | |
| 4 | Arcadia | California | United States | 91007 | |
| 5 | Beverly Hills | California | United States | 90211 | |
| 6 | La Jolla | California | United States | 92037 | |
| 7 | Mountain View | California | United States | 94040 | |
| 8 | Oakland | California | United States | 94609 | |
| 9 | Sacramento | California | United States | 95841 | |
| 10 | Torrance | California | United States | 90503 | |
| 11 | New London | Connecticut | United States | 06320 | |
| 12 | Altamonte Springs | Florida | United States | 32701 | |
| 13 | Fort Lauderdale | Florida | United States | 33334 | |
| 14 | Fort Myers | Florida | United States | 33907 | |
| 15 | Fort Myers | Florida | United States | 33912 | |
| 16 | Miami | Florida | United States | 33143 | |
| 17 | Palm Beach Gardens | Florida | United States | 33410 | |
| 18 | Winter Haven | Florida | United States | 33880 | |
| 19 | Augusta | Georgia | United States | 30909 | |
| 20 | Chicago | Illinois | United States | 60612 | |
| 21 | Wichita | Kansas | United States | 67214 | |
| 22 | Baltimore | Maryland | United States | 21209 | |
| 23 | Hagerstown | Maryland | United States | 21740 | |
| 24 | Towson | Maryland | United States | 21204 | |
| 25 | Boston | Massachusetts | United States | 02114 | |
| 26 | Grand Rapids | Michigan | United States | 49525 | |
| 27 | Jackson | Michigan | United States | 48104 | |
| 28 | Lincoln | Nebraska | United States | 68506 | |
| 29 | Las Vegas | Nevada | United States | 89135 | |
| 30 | Northfield | New Jersey | United States | 08225 | |
| 31 | Toms River | New Jersey | United States | 08755 | |
| 32 | Rochester | New York | United States | 14620 | |
| 33 | Winston-Salem | North Carolina | United States | 27157 | |
| 34 | Cleveland | Ohio | United States | 44195 | |
| 35 | Oklahoma City | Oklahoma | United States | 73104 | |
| 36 | Portland | Oregon | United States | 97210 | |
| 37 | Salem | Oregon | United States | 97302 | |
| 38 | Kingston | Pennsylvania | United States | 18704 | |
| 39 | Pittsburgh | Pennsylvania | United States | 15213 | |
| 40 | West Columbia | South Carolina | United States | 29169 | |
| 41 | Rapid City | South Dakota | United States | 57701 | |
| 42 | Nashville | Tennessee | United States | 37203 | |
| 43 | Abilene | Texas | United States | 79606 | |
| 44 | Ft Worth | Texas | United States | 76102 | |
| 45 | Houston | Texas | United States | 77030 | |
| 46 | San Antonio | Texas | United States | 78240 | |
| 47 | Vancouver | British Columbia | Canada | V5Z 3N9 | |
| 48 | Victoria | British Columbia | Canada | V8V 4X3 | |
| 49 | Halifax | Nova Scotia | Canada | B3H 2Y9 | |
| 50 | London | Ontario | Canada | N6A 4V2 | |
| 51 | Mississauga | Ontario | Canada | L4W 1W9 | |
| 52 | Toronto | Ontario | Canada | M4N 3M5 | |
| 53 | Medellin | Antioquia | Colombia | ||
| 54 | Bogota | Colombia | |||
| 55 | Hyderabad | A.p. | India | 500034 | |
| 56 | Bangalore | Karnataka | India | 560010 | |
| 57 | Kolkata | West Bengal | India | 700073 | |
| 58 | Kfar-Saba | Israel | 44281 | ||
| 59 | Petah Tikva | Israel | 49100 | ||
| 60 | Rehovot | Israel | 76100 | ||
| 61 | Tel Aviv | Israel | 64239 |
Sponsors and Collaborators
- Regeneron Pharmaceuticals
- Bayer
Investigators
- Study Director: Clinical Trial Management, Regeneron Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00943072
Other Study ID Numbers:
- VGFT-OD-0819
First Posted:
Jul 21, 2009
Last Update Posted:
May 27, 2013
Last Verified:
Apr 1, 2013
Keywords provided by Regeneron Pharmaceuticals
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | The study was conducted at 55 study centers in the United States, Canada, Columbia, India, and Israel. The recruitment period occurred between 08 Jul 2009 and 29 Apr 2010. |
|---|---|
| Pre-assignment Detail | 273 participants were screened, 189 randomized, and 188 were included in the Safety Analysis Set (SAF). The Full Analysis Set (FAS) included 187 participants with at least one post-baseline assessment. |
| Arm/Group Title | Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) | Sham Treatment |
|---|---|---|
| Arm/Group Description | Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24. Starting at week 24 through week 52, participants were evaluated monthly to receive either the 2 mg IAI PRN or sham injection according to the protocol re-treatment criteria as assessed by the masked physician. If none of the re-treatment criteria were met, participants received a sham injection. From Week 52 to 100, participants were evaluated every three months, but could receive injections of IAI up to monthly if re-treatment criteria were met; sham injections were not given. Participants were observed from Week 24 to Week 100. Participants in the safety population that completed Week 24 were at risk. | Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24. Starting at week 24 through week 52, participants were eligible for active treatment and were evaluated monthly to receive either 2 mg IAI PRN or sham injection according to the protocol re-treatment criteria as assessed by the masked physician. From Week 52 to 100, participants were evaluated every three months, but could receive injections of IAI up to monthly if re-treatment criteria were met; sham injections were not given. |
| Period Title: Overall Study | ||
| STARTED | 115 | 74 |
| Participants Received Treatment | 114 | 74 |
| Full Analysis Set (FAS) Population | 114 | 73 |
| COMPLETED | 110 | 60 |
| NOT COMPLETED | 5 | 14 |
Baseline Characteristics
| Arm/Group Title | Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) | Sham Treatment | Total |
|---|---|---|---|
| Arm/Group Description | Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24. | Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24. | Total of all reporting groups |
| Overall Participants | 114 | 74 | 188 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
65.5
(13.57)
|
67.5
(14.22)
|
66.3
(13.83)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
45
39.5%
|
35
47.3%
|
80
42.6%
|
| Male |
69
60.5%
|
39
52.7%
|
108
57.4%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
18
15.8%
|
12
16.2%
|
30
16%
|
| Not Hispanic or Latino |
96
84.2%
|
62
83.8%
|
158
84%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
2
1.8%
|
0
0%
|
2
1.1%
|
| Asian |
7
6.1%
|
2
2.7%
|
9
4.8%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
1
1.4%
|
1
0.5%
|
| Black or African American |
5
4.4%
|
5
6.8%
|
10
5.3%
|
| White |
88
77.2%
|
60
81.1%
|
148
78.7%
|
| More than one race |
12
10.5%
|
6
8.1%
|
18
9.6%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Baseline Retinal Thickness by Optical Coherence Tomography (OCT) (microns) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [microns] |
661.7
(237.37)
|
678.4
(248.66)
|
668.1
(241.23)
|
| 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] |
77.67
(15.96)
|
78.01
(16.26)
|
77.81
(16.04)
|
| Baseline Intraocular Pressure (millimeters of mercury (mmHg)) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [millimeters of mercury (mmHg)] |
15.1
(3.26)
|
15.0
(2.83)
|
15.1
(3.09)
|
| Number of Participants with Retinal Perfusion at Baseline (participants) [Number] | |||
| Perfused |
77
67.5%
|
50
67.6%
|
127
67.6%
|
| Non-Perfused |
17
14.9%
|
12
16.2%
|
29
15.4%
|
| Indeterminate |
20
17.5%
|
12
16.2%
|
32
17%
|
| Baseline Best Corrected Visual Acuity (BCVA) Letter Score (letters correctly read) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [letters correctly read] |
50.7
(13.90)
|
48.7
(14.41)
|
49.9
(14.10)
|
| Time Since Central Retinal Vein Occlusion (CRVO) Diagnosis (participants) [Number] | |||
| </= 2 Months |
64
56.1%
|
53
71.6%
|
117
62.2%
|
| > 2 Months |
49
43%
|
21
28.4%
|
70
37.2%
|
| Missing |
1
0.9%
|
0
0%
|
1
0.5%
|
Outcome Measures
| Title | Percentage of Participants Who Gained at Least 15 Letters in BCVA at Week 24 as Measured by ETDRS Letter Score |
|---|---|
| Description | Percentage values indicate the number of subjects in each arm who were able to read an additional 15 letters or more at Week 24 compared to baseline. Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 24 letters (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning. |
| Time Frame | Baseline and at Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set |
| Arm/Group Title | Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) | Sham Treatment |
|---|---|---|
| Arm/Group Description | Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24. | Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24. |
| Measure Participants | 114 | 73 |
| Number [percentage of participants] |
64
56.1%
|
9
12.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye), Sham Treatment |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.0001 |
| Comments | P-value for the primary endpoint was calculated using 2-sided Cochran-Mantel-Haenszel test adjusted by regions (North America vs. Rest of World) and baseline BCVA (BCVA > 20/200 and BCVA ≤ 20/200) | |
| Method | Cochran-Mantel-Haenszel | |
| Comments | CMH adjusted difference | |
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | 44.8 | |
| Confidence Interval |
(2-Sided) 95% 33.0 to 56.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The Risk Difference (RD) indicates the difference between the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group. | |
| Title | Change From Baseline in BCVA as Measured by ETDRS Letter Score at Week 24 - Last Observation Carried Forward (LOCF) |
|---|---|
| Description | Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning. |
| Time Frame | Baseline and at Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set |
| Arm/Group Title | Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) | Sham Treatment |
|---|---|---|
| Arm/Group Description | Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24. | Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24. |
| Measure Participants | 114 | 73 |
| Mean (Standard Deviation) [letters correctly read] |
17.3
(12.78)
|
-4.0
(17.96)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye), Sham Treatment |
|---|---|---|
| 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 | Risk Difference (RD) |
| Estimated Value | 21.70 | |
| Confidence Interval |
(2-Sided) 95% 17.36 to 26.04 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | RD is the IAI group minus sham group. 95% confidence interval is for the RD. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye), Sham Treatment |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Square Mean |
| Estimated Value | 16.36 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | LS Mean indicates is the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group. | |
| Title | Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF |
|---|---|
| Description | |
| Time Frame | Baseline and at Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set |
| Arm/Group Title | Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) | Sham Treatment |
|---|---|---|
| Arm/Group Description | Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24. | Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24. |
| Measure Participants | 114 | 73 |
| Mean (Standard Deviation) [microns] |
-457.2
(238.21)
|
-144.8
(291.07)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye), Sham Treatment |
|---|---|---|
| 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 | Risk Difference (RD) |
| Estimated Value | -311.9 | |
| Confidence Interval |
(2-Sided) 95% -389.4 to -234.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The Risk Difference (RD) indicates the difference between the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group. 95% confidence interval is for the RD. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye), Sham Treatment |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Square Mean |
| Estimated Value | -487.1 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The Least Square Mean indicates the difference between the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group. | |
| Title | Percentage of Participants Progressing to Any of the Following: Anterior Segment Neovascularization, New Vessels of the Disc (NVD) or New Vessels Elsewhere (NVE) During the First 24 Weeks |
|---|---|
| Description | |
| Time Frame | Baseline to Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set |
| Arm/Group Title | Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) | Sham Treatment |
|---|---|---|
| Arm/Group Description | Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24. | Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24. |
| Measure Participants | 114 | 73 |
| Any neovascularization |
0
0%
|
6.8
9.2%
|
| Anterior segment neovascularization |
0
0%
|
6.8
9.2%
|
| Neovascularization of the optic disc (NVD) |
0
0%
|
0
0%
|
| Neovascularization elsewhere in the fundus (NVE) |
0
0%
|
0
0%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye), Sham Treatment |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0059 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | CMH adjusted difference | |
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | -6.6 | |
| Confidence Interval |
(2-Sided) 95% -12.2 to -1.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The Risk Difference (RD) indicates the difference between the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group. 95% confidence interval is for the RD. | |
| Title | Change From Baseline in the NEI VFQ-25 in Total Score at Week 24 (LOCF) |
|---|---|
| Description | The NEI VFQ-25 assesses visual function and quality of life. 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 and at Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) | Sham Treatment |
|---|---|---|
| Arm/Group Description | Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24. | Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24. |
| Measure Participants | 114 | 73 |
| Mean (Standard Deviation) [scores on a scale] |
7.2
(12.11)
|
0.8
(9.79)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye), Sham Treatment |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0009 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | 6.26 | |
| Confidence Interval |
(2-Sided) 95% 2.61 to 9.91 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The Risk Difference (RD) indicates the difference between the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group. 95% confidence interval is for the RD. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye), Sham Treatment |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Square Mean |
| Estimated Value | 8.80 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Least Square Mean indicates the difference between the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group. | |
Adverse Events
| Time Frame | Baseline to Week 24; Week 24 to Week 100 | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Adverse event data were collected from the sites during the time period from Baseline through Week 24 or/and Week 100. For analysis, adverse events with a start date on or after the Week 24 visit date are summarized in the Week 24 to Week 100 time period. | |||||||
| Arm/Group Title | Intravitreal Aflibercept Injection (IAI) (Baseline to Week 24) | Sham Treatment (Baseline to Week 24) | IAI to IAI (Week 24 to Week 100) | Sham Treatment to IAI (Week 24 to Week 100) | ||||
| Arm/Group Description | Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 20. Participants were observed until Week 24. Participants in the safety population were at risk. | Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 20. Participants were observed until Week 24. Participants in the safety population were at risk. | Starting at week 24 through week 52, participants were evaluated monthly to receive either the 2 mg Intravitreal Aflibercept Injection (IAI) PRN or sham injection according to the protocol re-treatment criteria as assessed by the masked physician. If none of the re-treatment criteria were met, participants received a sham injection. From Week 52 to 100, participants were evaluated every three months, but could receive injections of IAI up to monthly if re-treatment criteria were met; sham injections were not given. Participants were observed from Week 24 to Week 100. Participants in the safety population that completed Week 24 were at risk. | Starting at week 24 through week 52, participants were eligible for active treatment and were evaluated monthly to receive either 2 mg Intravitreal Aflibercept Injection (IAI) PRN or sham injection according to the protocol re-treatment criteria as assessed by the masked physician. From Week 52 to 100, participants were evaluated every three months, but could receive injections of IAI up to monthly if re-treatment criteria were met; sham injections were not given. | ||||
All Cause Mortality |
||||||||
| Intravitreal Aflibercept Injection (IAI) (Baseline to Week 24) | Sham Treatment (Baseline to Week 24) | IAI to IAI (Week 24 to Week 100) | Sham Treatment to IAI (Week 24 to Week 100) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Intravitreal Aflibercept Injection (IAI) (Baseline to Week 24) | Sham Treatment (Baseline to Week 24) | IAI to IAI (Week 24 to Week 100) | Sham Treatment to IAI (Week 24 to Week 100) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/114 (5.3%) | 6/74 (8.1%) | 20/110 (18.2%) | 14/60 (23.3%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anaemia | 1/114 (0.9%) | 0/74 (0%) | 0/110 (0%) | 1/60 (1.7%) | ||||
| Neutropenia | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 1/60 (1.7%) | ||||
| Pernicious anaemia | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 1/60 (1.7%) | ||||
| Cardiac disorders | ||||||||
| Acute myocardial infarction | 0/114 (0%) | 1/74 (1.4%) | 0/110 (0%) | 0/60 (0%) | ||||
| Aortic valve stenosis | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Atrial fibrillation | 1/114 (0.9%) | 0/74 (0%) | 1/110 (0.9%) | 1/60 (1.7%) | ||||
| Atrial tachycardia | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Atrioventricular block | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Cardiac failure acute | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Coronary artery disease | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Coronary artery stenosis | 0/114 (0%) | 0/74 (0%) | 2/110 (1.8%) | 0/60 (0%) | ||||
| Myocardial infarction | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Supraventricular tachycardia | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Ventricular extrasystoles | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Eye disorders | ||||||||
| Cataract | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Conjunctival haemorrhage | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Cystoid macular oedema | 0/114 (0%) | 0/74 (0%) | 2/110 (1.8%) | 0/60 (0%) | ||||
| Dry eye | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 0/60 (0%) | ||||
| Eye irritation | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 0/60 (0%) | ||||
| Eye pain | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 0/60 (0%) | ||||
| Glaucoma | 0/114 (0%) | 2/74 (2.7%) | 0/110 (0%) | 1/60 (1.7%) | ||||
| Iris neovascularisation | 0/114 (0%) | 2/74 (2.7%) | 0/110 (0%) | 0/60 (0%) | ||||
| Lacrimation increased | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 0/60 (0%) | ||||
| Macular fibrosis | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Macular oedema | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Maculopathy | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 0/60 (0%) | ||||
| Optic disc vascular disorder | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 0/60 (0%) | ||||
| Posterior capsule opacification | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Retinal artery occlusion | 1/114 (0.9%) | 0/74 (0%) | 0/110 (0%) | 0/60 (0%) | ||||
| Retinal exudates | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 0/60 (0%) | ||||
| Retinal haemorrhage | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 0/60 (0%) | ||||
| Retinal pigment epitheliopathy | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 0/60 (0%) | ||||
| Retinal tear | 0/114 (0%) | 1/74 (1.4%) | 0/110 (0%) | 1/60 (1.7%) | ||||
| Retinal vascular disorder | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Retinal vein occlusion | 0/114 (0%) | 1/74 (1.4%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Visual acuity reduced | 1/114 (0.9%) | 1/74 (1.4%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Vitreous detachment | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 0/60 (0%) | ||||
| Vitreous floaters | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 0/60 (0%) | ||||
| Vitreous haemorrhage | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal adhesions | 1/114 (0.9%) | 0/74 (0%) | 0/110 (0%) | 0/60 (0%) | ||||
| Colitis | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 1/60 (1.7%) | ||||
| Dysphagia | 1/114 (0.9%) | 0/74 (0%) | 0/110 (0%) | 1/60 (1.7%) | ||||
| Gastrointestinal motility disorder | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 1/60 (1.7%) | ||||
| Inguinal hernia | 0/114 (0%) | 0/74 (0%) | 2/110 (1.8%) | 0/60 (0%) | ||||
| Intestinal ischaemia | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 1/60 (1.7%) | ||||
| Intestinal obstruction | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 1/60 (1.7%) | ||||
| Pancreatitis | 0/114 (0%) | 1/74 (1.4%) | 0/110 (0%) | 1/60 (1.7%) | ||||
| Small intestinal obstruction | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 1/60 (1.7%) | ||||
| General disorders | ||||||||
| Adhesion | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 1/60 (1.7%) | ||||
| Chest discomfort | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Chest pain | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Generalised oedema | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Hepatobiliary disorders | ||||||||
| Bile duct stone | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 1/60 (1.7%) | ||||
| Cholecystitis | 0/114 (0%) | 1/74 (1.4%) | 0/110 (0%) | 0/60 (0%) | ||||
| Infections and infestations | ||||||||
| Arthritis bacterial | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Bacteriuria | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Bronchitis | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 1/60 (1.7%) | ||||
| Bronchitis viral | 1/114 (0.9%) | 0/74 (0%) | 0/110 (0%) | 0/60 (0%) | ||||
| Cellulitis | 0/114 (0%) | 1/74 (1.4%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Clostridial infection | 0/114 (0%) | 1/74 (1.4%) | 0/110 (0%) | 0/60 (0%) | ||||
| Endophthalmitis | 1/114 (0.9%) | 0/74 (0%) | 0/110 (0%) | 0/60 (0%) | ||||
| Herpes oesophagitis | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 1/60 (1.7%) | ||||
| Influenza | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 0/60 (0%) | ||||
| Nasopharyngitis | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 0/60 (0%) | ||||
| Periorbital cellulitis | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 1/60 (1.7%) | ||||
| Pneumonia | 0/114 (0%) | 1/74 (1.4%) | 0/110 (0%) | 3/60 (5%) | ||||
| Upper respiratory tract infection | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 0/60 (0%) | ||||
| Urinary tract infection | 0/114 (0%) | 0/74 (0%) | 2/110 (1.8%) | 0/60 (0%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Accident | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 1/60 (1.7%) | ||||
| Brain contusion | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Corneal abrasion | 1/114 (0.9%) | 0/74 (0%) | 0/110 (0%) | 0/60 (0%) | ||||
| Craniocerebral injury | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Facial bones fracture | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Fall | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 1/60 (1.7%) | ||||
| Femur fracture | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 1/60 (1.7%) | ||||
| In-stent coronary artery restenosis | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Radius fracture | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Renal haematoma | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Skull fracture | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Spinal column injury | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Investigations | ||||||||
| Blood pressure systolic increased | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 0/60 (0%) | ||||
| Blood urine present | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 0/60 (0%) | ||||
| Intraocular pressure increased | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Protein urine present | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 0/60 (0%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Abnormal loss of weight | 1/114 (0.9%) | 0/74 (0%) | 0/110 (0%) | 0/60 (0%) | ||||
| Dehydration | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 1/60 (1.7%) | ||||
| Hypokalaemia | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 1/60 (1.7%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthritis | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 1/60 (1.7%) | ||||
| Intervertebral disc degeneration | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 1/60 (1.7%) | ||||
| Intervertebral disc protrusion | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Osteoarthritis | 1/114 (0.9%) | 0/74 (0%) | 0/110 (0%) | 1/60 (1.7%) | ||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Colon cancer | 0/114 (0%) | 1/74 (1.4%) | 0/110 (0%) | 1/60 (1.7%) | ||||
| Mantle cell lymphoma | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 1/60 (1.7%) | ||||
| Metastatic renal cell carcinoma | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Non-small cell lung cancer | 1/114 (0.9%) | 0/74 (0%) | 0/110 (0%) | 0/60 (0%) | ||||
| Oesophageal adenocarcinoma stage IV | 0/114 (0%) | 1/74 (1.4%) | 0/110 (0%) | 0/60 (0%) | ||||
| Prostate cancer | 0/114 (0%) | 1/74 (1.4%) | 0/110 (0%) | 0/60 (0%) | ||||
| Squamous cell carcinoma of skin | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Thyroid cancer | 0/114 (0%) | 1/74 (1.4%) | 0/110 (0%) | 0/60 (0%) | ||||
| Nervous system disorders | ||||||||
| Carotid artery stenosis | 0/114 (0%) | 1/74 (1.4%) | 0/110 (0%) | 0/60 (0%) | ||||
| Convulsion | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Dementia | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Encephalopathy | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Haemorrhagic cerebral infarction | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Loss of consciousness | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Subarachnoid haemorrhage | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Syncope | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Psychiatric disorders | ||||||||
| Mental status changes | 0/114 (0%) | 1/74 (1.4%) | 0/110 (0%) | 0/60 (0%) | ||||
| Renal and urinary disorders | ||||||||
| Haematuria | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Obstructive uropathy | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Renal failure acute | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 2/60 (3.3%) | ||||
| Renal failure chronic | 0/114 (0%) | 1/74 (1.4%) | 0/110 (0%) | 0/60 (0%) | ||||
| Reproductive system and breast disorders | ||||||||
| Benign prostatic hyperplasia | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Cystocele | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 1/60 (1.7%) | ||||
| Rectocele | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 1/60 (1.7%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Apnoea | 0/114 (0%) | 1/74 (1.4%) | 0/110 (0%) | 0/60 (0%) | ||||
| Asthma | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Epistaxis | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Pneumonia aspiration | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Pneumothorax | 1/114 (0.9%) | 0/74 (0%) | 0/110 (0%) | 0/60 (0%) | ||||
| Respiratory failure | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 1/60 (1.7%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Dermatitis contact | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
| Vascular disorders | ||||||||
| Hypertension | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 0/60 (0%) | ||||
| Hypotension | 0/114 (0%) | 0/74 (0%) | 1/110 (0.9%) | 0/60 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Intravitreal Aflibercept Injection (IAI) (Baseline to Week 24) | Sham Treatment (Baseline to Week 24) | IAI to IAI (Week 24 to Week 100) | Sham Treatment to IAI (Week 24 to Week 100) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 57/114 (50%) | 34/74 (45.9%) | 76/110 (69.1%) | 50/60 (83.3%) | ||||
| Eye disorders | ||||||||
| Cataract | 0/114 (0%) | 0/74 (0%) | 6/110 (5.5%) | 0/60 (0%) | ||||
| Cystoid macular oedema | 0/114 (0%) | 0/74 (0%) | 14/110 (12.7%) | 4/60 (6.7%) | ||||
| Dry eye | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 4/60 (6.7%) | ||||
| Eye irritation | 6/114 (5.3%) | 0/74 (0%) | 0/110 (0%) | 0/60 (0%) | ||||
| Eye pain | 16/114 (14%) | 4/74 (5.4%) | 9/110 (8.2%) | 4/60 (6.7%) | ||||
| Iris neovascularisation | 0/114 (0%) | 4/74 (5.4%) | 0/110 (0%) | 0/60 (0%) | ||||
| Lacrimation increased | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 4/60 (6.7%) | ||||
| Macular oedema | 0/114 (0%) | 0/74 (0%) | 20/110 (18.2%) | 0/60 (0%) | ||||
| Maculopathy | 10/114 (8.8%) | 0/74 (0%) | 6/110 (5.5%) | 0/60 (0%) | ||||
| Optic disc vascular disorder | 8/114 (7%) | 0/74 (0%) | 6/110 (5.5%) | 5/60 (8.3%) | ||||
| Retinal exudates | 7/114 (6.1%) | 0/74 (0%) | 0/110 (0%) | 5/60 (8.3%) | ||||
| Retinal haemorrhage | 0/114 (0%) | 0/74 (0%) | 6/110 (5.5%) | 4/60 (6.7%) | ||||
| Retinal pigment epitheliopathy | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 12/60 (20%) | ||||
| Retinal vascular disorder | 6/114 (5.3%) | 4/74 (5.4%) | 8/110 (7.3%) | 0/60 (0%) | ||||
| Visual acuity reduced | 7/114 (6.1%) | 12/74 (16.2%) | 27/110 (24.5%) | 8/60 (13.3%) | ||||
| Vitreous detachment | 0/114 (0%) | 5/74 (6.8%) | 8/110 (7.3%) | 0/60 (0%) | ||||
| Vitreous floaters | 6/114 (5.3%) | 0/74 (0%) | 0/110 (0%) | 0/60 (0%) | ||||
| Infections and infestations | ||||||||
| Influenza | 0/114 (0%) | 0/74 (0%) | 7/110 (6.4%) | 0/60 (0%) | ||||
| Nasopharyngitis | 0/114 (0%) | 4/74 (5.4%) | 6/110 (5.5%) | 0/60 (0%) | ||||
| Upper respiratory tract infection | 6/114 (5.3%) | 0/74 (0%) | 6/110 (5.5%) | 0/60 (0%) | ||||
| Investigations | ||||||||
| Blood pressure systolic increased | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 4/60 (6.7%) | ||||
| Blood urine present | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 4/60 (6.7%) | ||||
| Intraocular pressure increased | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 4/60 (6.7%) | ||||
| Protein urine present | 0/114 (0%) | 0/74 (0%) | 0/110 (0%) | 5/60 (8.3%) | ||||
| Vascular disorders | ||||||||
| Hypertension | 10/114 (8.8%) | 4/74 (5.4%) | 13/110 (11.8%) | 9/60 (15%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI, after completion of the trial and multi-center publication, is that the sponsor can review results communications prior to public release & may have the right to embargo communications regarding results for a period between 60 & 180 days from the time submitted to the sponsor for review; provided that the sponsor can remove confidential/proprietary information. The sponsor cannot require other changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Clinical Trials Administrator |
|---|---|
| Organization | Regeneron Pharmaceuticals |
| Phone | 914 847 5385 |
| clinicaltrials@regeneron.com |
Responsible Party:
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00943072
Other Study ID Numbers:
- VGFT-OD-0819
First Posted:
Jul 21, 2009
Last Update Posted:
May 27, 2013
Last Verified:
Apr 1, 2013