Trial Outcomes & Findings for Intravitreal Aflibercept for Retinal Non-Perfusion in Proliferative Diabetic Retinopathy (NCT NCT02863354)
NCT ID: NCT02863354
Last Updated: 2021-05-24
Results Overview
• Assess the safety and tolerability of IAI for the treatment of proliferative diabetic retinopathy by evaluating the incidence and severity of ocular and systemic adverse events through week 52 and week 100.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
52 and 100 weeks
Results posted on
2021-05-24
Participant Flow
Unit of analysis: Eyes
Participant milestones
| Measure |
Q4WKS
Aflibercept 2 mg every 4 weeks (defined as every 28 days (+ 7 days) and at least 21 days between injections) through week 48. Following week 48, aflibercept 2 mg every 12 weeks through week 96.
If NV or PDR are worse per pre-specified criteria at week 60, or at any study visit thereafter, the subject will be treated every 4 weeks through the end of the study.
Aflibercept: Intravitreal injection
|
Q12WKS
Aflibercept 2 mg every 12-weeks. Subjects will be followed every 4 weeks through week 12, and can be treated if the pre-specified criteria are met. Starting at week 12 if NV or PDR are stable or improved (as assessed by investigator) the subject will be monitored and treated at a 12-week interval through week 48. If NV or PDR are worse per the pre-specified criteria at week 12, or at any study visit thereafter, the subject will be treated monthly through the end of the study.
At week 52, aflibercept 2 mg every 4 weeks (defined as 28 days (+ 7 days) and at least 21 days between injections) for subjects with visible retinal non-perfusion. If retinal non-perfusion has completely resolved at week 72, aflibercept every 12 weeks through end of study. For subjects without retinal non-perfusion at week 52, aflibercept 2 mg every 12 weeks through the end of study.
Aflibercept: Intravitreal injection
|
|---|---|---|
|
Year 1
STARTED
|
23 23
|
20 20
|
|
Year 1
COMPLETED
|
19 19
|
18 18
|
|
Year 1
NOT COMPLETED
|
4 4
|
2 2
|
|
Year 2
STARTED
|
19 19
|
18 18
|
|
Year 2
COMPLETED
|
17 17
|
16 16
|
|
Year 2
NOT COMPLETED
|
2 2
|
2 2
|
Reasons for withdrawal
| Measure |
Q4WKS
Aflibercept 2 mg every 4 weeks (defined as every 28 days (+ 7 days) and at least 21 days between injections) through week 48. Following week 48, aflibercept 2 mg every 12 weeks through week 96.
If NV or PDR are worse per pre-specified criteria at week 60, or at any study visit thereafter, the subject will be treated every 4 weeks through the end of the study.
Aflibercept: Intravitreal injection
|
Q12WKS
Aflibercept 2 mg every 12-weeks. Subjects will be followed every 4 weeks through week 12, and can be treated if the pre-specified criteria are met. Starting at week 12 if NV or PDR are stable or improved (as assessed by investigator) the subject will be monitored and treated at a 12-week interval through week 48. If NV or PDR are worse per the pre-specified criteria at week 12, or at any study visit thereafter, the subject will be treated monthly through the end of the study.
At week 52, aflibercept 2 mg every 4 weeks (defined as 28 days (+ 7 days) and at least 21 days between injections) for subjects with visible retinal non-perfusion. If retinal non-perfusion has completely resolved at week 72, aflibercept every 12 weeks through end of study. For subjects without retinal non-perfusion at week 52, aflibercept 2 mg every 12 weeks through the end of study.
Aflibercept: Intravitreal injection
|
|---|---|---|
|
Year 1
Lost to Follow-up
|
1
|
1
|
|
Year 1
Withdrawal by Subject
|
3
|
0
|
|
Year 1
Death
|
0
|
1
|
|
Year 2
Lost to Follow-up
|
2
|
2
|
Baseline Characteristics
3 subjects enrolled were withdrawn early in the trial and replaced.
Baseline characteristics by cohort
| Measure |
Q4WKS
n=20 Eyes
Aflibercept 2 mg every 4 weeks (defined as every 28 days (+ 7 days) and at least 21 days between injections) through week 48. Following week 48, aflibercept 2 mg every 12 weeks through week 96.
If NV or PDR are worse per pre-specified criteria at week 60, or at any study visit thereafter, the subject will be treated every 4 weeks through the end of the study.
Aflibercept: Intravitreal injection
|
Q12WKS
n=20 Eyes
Aflibercept 2 mg every 12-weeks. Subjects will be followed every 4 weeks through week 12, and can be treated if the pre-specified criteria are met. Starting at week 12 if NV or PDR are stable or improved (as assessed by investigator) the subject will be monitored and treated at a 12-week interval through week 48. If NV or PDR are worse per the pre-specified criteria at week 12, or at any study visit thereafter, the subject will be treated monthly through the end of the study.
At week 52, aflibercept 2 mg every 4 weeks (defined as 28 days (+ 7 days) and at least 21 days between injections) for subjects with visible retinal non-perfusion. If retinal non-perfusion has completely resolved at week 72, aflibercept every 12 weeks through end of study. For subjects without retinal non-perfusion at week 52, aflibercept 2 mg every 12 weeks through the end of study.
Aflibercept: Intravitreal injection
|
Total
n=40 Eyes
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Eyes
n=20 Eyes
|
0 Eyes
n=20 Eyes
|
0 Eyes
n=40 Eyes
|
|
Age, Categorical
Between 18 and 65 years
|
2 Eyes
n=20 Eyes
|
2 Eyes
n=20 Eyes
|
4 Eyes
n=40 Eyes
|
|
Age, Categorical
>=65 years
|
18 Eyes
n=20 Eyes
|
18 Eyes
n=20 Eyes
|
36 Eyes
n=40 Eyes
|
|
Age, Continuous
|
47.7 Years
n=20 Participants • 3 subjects enrolled were withdrawn early in the trial and replaced.
|
48.3 Years
n=20 Participants • 3 subjects enrolled were withdrawn early in the trial and replaced.
|
48 Years
n=40 Participants • 3 subjects enrolled were withdrawn early in the trial and replaced.
|
|
Sex: Female, Male
Female
|
11 Eyes
n=20 Eyes
|
8 Eyes
n=20 Eyes
|
19 Eyes
n=40 Eyes
|
|
Sex: Female, Male
Male
|
9 Eyes
n=20 Eyes
|
12 Eyes
n=20 Eyes
|
21 Eyes
n=40 Eyes
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants • 3 subjects enrolled were withdrawn early in the trial and replaced.
|
0 Participants
n=20 Participants • 3 subjects enrolled were withdrawn early in the trial and replaced.
|
0 Participants
n=40 Participants • 3 subjects enrolled were withdrawn early in the trial and replaced.
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=20 Participants • 3 subjects enrolled were withdrawn early in the trial and replaced.
|
1 Participants
n=20 Participants • 3 subjects enrolled were withdrawn early in the trial and replaced.
|
2 Participants
n=40 Participants • 3 subjects enrolled were withdrawn early in the trial and replaced.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants • 3 subjects enrolled were withdrawn early in the trial and replaced.
|
0 Participants
n=20 Participants • 3 subjects enrolled were withdrawn early in the trial and replaced.
|
0 Participants
n=40 Participants • 3 subjects enrolled were withdrawn early in the trial and replaced.
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=20 Participants • 3 subjects enrolled were withdrawn early in the trial and replaced.
|
8 Participants
n=20 Participants • 3 subjects enrolled were withdrawn early in the trial and replaced.
|
10 Participants
n=40 Participants • 3 subjects enrolled were withdrawn early in the trial and replaced.
|
|
Race (NIH/OMB)
White
|
13 Participants
n=20 Participants • 3 subjects enrolled were withdrawn early in the trial and replaced.
|
10 Participants
n=20 Participants • 3 subjects enrolled were withdrawn early in the trial and replaced.
|
23 Participants
n=40 Participants • 3 subjects enrolled were withdrawn early in the trial and replaced.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants • 3 subjects enrolled were withdrawn early in the trial and replaced.
|
0 Participants
n=20 Participants • 3 subjects enrolled were withdrawn early in the trial and replaced.
|
0 Participants
n=40 Participants • 3 subjects enrolled were withdrawn early in the trial and replaced.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=20 Participants • 3 subjects enrolled were withdrawn early in the trial and replaced.
|
1 Participants
n=20 Participants • 3 subjects enrolled were withdrawn early in the trial and replaced.
|
5 Participants
n=40 Participants • 3 subjects enrolled were withdrawn early in the trial and replaced.
|
|
Region of Enrollment
United States
|
20 participants
n=20 Participants • 3 subjects enrolled were withdrawn early in the trial and replaced.
|
20 participants
n=20 Participants • 3 subjects enrolled were withdrawn early in the trial and replaced.
|
40 participants
n=40 Participants • 3 subjects enrolled were withdrawn early in the trial and replaced.
|
PRIMARY outcome
Timeframe: 52 and 100 weeksPopulation: 3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.
• Assess the safety and tolerability of IAI for the treatment of proliferative diabetic retinopathy by evaluating the incidence and severity of ocular and systemic adverse events through week 52 and week 100.
Outcome measures
| Measure |
Q4WKS
n=20 Participants
Aflibercept 2 mg every 4 weeks (defined as every 28 days (+ 7 days) and at least 21 days between injections) through week 48. Following week 48, aflibercept 2 mg every 12 weeks through week 96.
If NV or PDR are worse per pre-specified criteria at week 60, or at any study visit thereafter, the subject will be treated every 4 weeks through the end of the study.
Aflibercept: Intravitreal injection
|
Q12WKS
n=20 Participants
Aflibercept 2 mg every 12-weeks. Subjects will be followed every 4 weeks through week 12, and can be treated if the pre-specified criteria are met. Starting at week 12 if NV or PDR are stable or improved (as assessed by investigator) the subject will be monitored and treated at a 12-week interval through week 48. If NV or PDR are worse per the pre-specified criteria at week 12, or at any study visit thereafter, the subject will be treated monthly through the end of the study.
At week 52, aflibercept 2 mg every 4 weeks (defined as 28 days (+ 7 days) and at least 21 days between injections) for subjects with visible retinal non-perfusion. If retinal non-perfusion has completely resolved at week 72, aflibercept every 12 weeks through end of study. For subjects without retinal non-perfusion at week 52, aflibercept 2 mg every 12 weeks through the end of study.
Aflibercept: Intravitreal injection
|
|---|---|---|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Week 52
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Week 100
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 52 weeks and 100 weeksPopulation: 3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study. Number analyzed at Week 52 and Week 100 differs from overall number analyzed due to lost to follow up or deceased participants.
Mean change in Early Treatment of Diabetic Retinopathy Study Best Corrected Visual Acuity (ETDRS-BCVA) from baseline to week 52 and week 100.
Outcome measures
| Measure |
Q4WKS
n=20 Participants
Aflibercept 2 mg every 4 weeks (defined as every 28 days (+ 7 days) and at least 21 days between injections) through week 48. Following week 48, aflibercept 2 mg every 12 weeks through week 96.
If NV or PDR are worse per pre-specified criteria at week 60, or at any study visit thereafter, the subject will be treated every 4 weeks through the end of the study.
Aflibercept: Intravitreal injection
|
Q12WKS
n=20 Participants
Aflibercept 2 mg every 12-weeks. Subjects will be followed every 4 weeks through week 12, and can be treated if the pre-specified criteria are met. Starting at week 12 if NV or PDR are stable or improved (as assessed by investigator) the subject will be monitored and treated at a 12-week interval through week 48. If NV or PDR are worse per the pre-specified criteria at week 12, or at any study visit thereafter, the subject will be treated monthly through the end of the study.
At week 52, aflibercept 2 mg every 4 weeks (defined as 28 days (+ 7 days) and at least 21 days between injections) for subjects with visible retinal non-perfusion. If retinal non-perfusion has completely resolved at week 72, aflibercept every 12 weeks through end of study. For subjects without retinal non-perfusion at week 52, aflibercept 2 mg every 12 weeks through the end of study.
Aflibercept: Intravitreal injection
|
|---|---|---|
|
Change in Early Treatment of Diabetic Retinopathy Severity Best Corrected Visual Acuity
Week 52
|
4.26 ETDRS letters
Interval 0.76 to 7.76
|
4.53 ETDRS letters
Interval 1.83 to 7.23
|
|
Change in Early Treatment of Diabetic Retinopathy Severity Best Corrected Visual Acuity
Week 100
|
4.06 ETDRS letters
Interval -0.91 to 9.03
|
8.88 ETDRS letters
Interval 4.66 to 13.09
|
SECONDARY outcome
Timeframe: 52 weeks and 100 weeksPopulation: 3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study. Number analyzed at Week 52 and Week 100 differs from overall number analyzed due to inability to analyze images, lost to follow up, or deceased participants.
Change in area of retinal capillary non-perfusion within the macula compared to baseline, as assessed by ultrawide-field fluorescein angiogram from baseline to week 52 and week 100.
Outcome measures
| Measure |
Q4WKS
n=20 Participants
Aflibercept 2 mg every 4 weeks (defined as every 28 days (+ 7 days) and at least 21 days between injections) through week 48. Following week 48, aflibercept 2 mg every 12 weeks through week 96.
If NV or PDR are worse per pre-specified criteria at week 60, or at any study visit thereafter, the subject will be treated every 4 weeks through the end of the study.
Aflibercept: Intravitreal injection
|
Q12WKS
n=20 Participants
Aflibercept 2 mg every 12-weeks. Subjects will be followed every 4 weeks through week 12, and can be treated if the pre-specified criteria are met. Starting at week 12 if NV or PDR are stable or improved (as assessed by investigator) the subject will be monitored and treated at a 12-week interval through week 48. If NV or PDR are worse per the pre-specified criteria at week 12, or at any study visit thereafter, the subject will be treated monthly through the end of the study.
At week 52, aflibercept 2 mg every 4 weeks (defined as 28 days (+ 7 days) and at least 21 days between injections) for subjects with visible retinal non-perfusion. If retinal non-perfusion has completely resolved at week 72, aflibercept every 12 weeks through end of study. For subjects without retinal non-perfusion at week 52, aflibercept 2 mg every 12 weeks through the end of study.
Aflibercept: Intravitreal injection
|
|---|---|---|
|
Change in Area of Retinal Capillary Non-perfusion Within the Macula
Week 52
|
0.048 mm^2
Standard Deviation 0.450
|
0.217 mm^2
Standard Deviation 0.388
|
|
Change in Area of Retinal Capillary Non-perfusion Within the Macula
Week 100
|
2.627 mm^2
Standard Deviation 5.171
|
0.940 mm^2
Standard Deviation 1.156
|
SECONDARY outcome
Timeframe: 52 weeks and 100 weeksPopulation: 3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study. Number analyzed at Week 52 and Week 100 differs from overall number analyzed due to inability to analyze images, lost to follow up, or deceased participants.
Change in area of retinal capillary non-perfusion outside of the macula from baseline to week 52 and week 100.
Outcome measures
| Measure |
Q4WKS
n=20 Participants
Aflibercept 2 mg every 4 weeks (defined as every 28 days (+ 7 days) and at least 21 days between injections) through week 48. Following week 48, aflibercept 2 mg every 12 weeks through week 96.
If NV or PDR are worse per pre-specified criteria at week 60, or at any study visit thereafter, the subject will be treated every 4 weeks through the end of the study.
Aflibercept: Intravitreal injection
|
Q12WKS
n=20 Participants
Aflibercept 2 mg every 12-weeks. Subjects will be followed every 4 weeks through week 12, and can be treated if the pre-specified criteria are met. Starting at week 12 if NV or PDR are stable or improved (as assessed by investigator) the subject will be monitored and treated at a 12-week interval through week 48. If NV or PDR are worse per the pre-specified criteria at week 12, or at any study visit thereafter, the subject will be treated monthly through the end of the study.
At week 52, aflibercept 2 mg every 4 weeks (defined as 28 days (+ 7 days) and at least 21 days between injections) for subjects with visible retinal non-perfusion. If retinal non-perfusion has completely resolved at week 72, aflibercept every 12 weeks through end of study. For subjects without retinal non-perfusion at week 52, aflibercept 2 mg every 12 weeks through the end of study.
Aflibercept: Intravitreal injection
|
|---|---|---|
|
Change in Area of Retinal Capillary Non-perfusion Outside of the Macula
Week 52
|
182.467 mm^2
Standard Deviation 202.341
|
240.472 mm^2
Standard Deviation 121.967
|
|
Change in Area of Retinal Capillary Non-perfusion Outside of the Macula
Week 100
|
342.651 mm^2
Standard Deviation 135.957
|
387.204 mm^2
Standard Deviation 169.233
|
SECONDARY outcome
Timeframe: 52 Weeks and 100 WeeksPopulation: 3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study. Number analyzed at Week 52 and Week 100 differs from overall number analyzed due to inability to analyze images, lost to follow up, or deceased participants.
Percentage of subjects with neovascularization regression (reduced area of neovascularization) as measured by the central image reading center from baseline to week 52 and week 100.
Outcome measures
| Measure |
Q4WKS
n=18 Participants
Aflibercept 2 mg every 4 weeks (defined as every 28 days (+ 7 days) and at least 21 days between injections) through week 48. Following week 48, aflibercept 2 mg every 12 weeks through week 96.
If NV or PDR are worse per pre-specified criteria at week 60, or at any study visit thereafter, the subject will be treated every 4 weeks through the end of the study.
Aflibercept: Intravitreal injection
|
Q12WKS
n=18 Participants
Aflibercept 2 mg every 12-weeks. Subjects will be followed every 4 weeks through week 12, and can be treated if the pre-specified criteria are met. Starting at week 12 if NV or PDR are stable or improved (as assessed by investigator) the subject will be monitored and treated at a 12-week interval through week 48. If NV or PDR are worse per the pre-specified criteria at week 12, or at any study visit thereafter, the subject will be treated monthly through the end of the study.
At week 52, aflibercept 2 mg every 4 weeks (defined as 28 days (+ 7 days) and at least 21 days between injections) for subjects with visible retinal non-perfusion. If retinal non-perfusion has completely resolved at week 72, aflibercept every 12 weeks through end of study. For subjects without retinal non-perfusion at week 52, aflibercept 2 mg every 12 weeks through the end of study.
Aflibercept: Intravitreal injection
|
|---|---|---|
|
Percentage of Subjects With Neovascularization Regression
Week 52
|
17 Participants
|
18 Participants
|
|
Percentage of Subjects With Neovascularization Regression
Week 100
|
17 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 52 Weeks and 100 WeeksPopulation: 3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study. Number analyzed at Week 52 and Week 100 differs from overall number analyzed due to inability to analyze images, lost to follow up, or deceased participants.
Percentage of subjects with increased neovascularization from baseline to week 52 and week 100.
Outcome measures
| Measure |
Q4WKS
n=18 Participants
Aflibercept 2 mg every 4 weeks (defined as every 28 days (+ 7 days) and at least 21 days between injections) through week 48. Following week 48, aflibercept 2 mg every 12 weeks through week 96.
If NV or PDR are worse per pre-specified criteria at week 60, or at any study visit thereafter, the subject will be treated every 4 weeks through the end of the study.
Aflibercept: Intravitreal injection
|
Q12WKS
n=18 Participants
Aflibercept 2 mg every 12-weeks. Subjects will be followed every 4 weeks through week 12, and can be treated if the pre-specified criteria are met. Starting at week 12 if NV or PDR are stable or improved (as assessed by investigator) the subject will be monitored and treated at a 12-week interval through week 48. If NV or PDR are worse per the pre-specified criteria at week 12, or at any study visit thereafter, the subject will be treated monthly through the end of the study.
At week 52, aflibercept 2 mg every 4 weeks (defined as 28 days (+ 7 days) and at least 21 days between injections) for subjects with visible retinal non-perfusion. If retinal non-perfusion has completely resolved at week 72, aflibercept every 12 weeks through end of study. For subjects without retinal non-perfusion at week 52, aflibercept 2 mg every 12 weeks through the end of study.
Aflibercept: Intravitreal injection
|
|---|---|---|
|
Percentage of Subjects With Increased Neovascularization
Week 52
|
1 Participants
|
0 Participants
|
|
Percentage of Subjects With Increased Neovascularization
Week 100
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 52 Weeks and 100 WeeksPopulation: 3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.
Percentage of subjects who develop vitreous hemorrhage from baseline to week 52 and week 100.
Outcome measures
| Measure |
Q4WKS
n=20 Participants
Aflibercept 2 mg every 4 weeks (defined as every 28 days (+ 7 days) and at least 21 days between injections) through week 48. Following week 48, aflibercept 2 mg every 12 weeks through week 96.
If NV or PDR are worse per pre-specified criteria at week 60, or at any study visit thereafter, the subject will be treated every 4 weeks through the end of the study.
Aflibercept: Intravitreal injection
|
Q12WKS
n=20 Participants
Aflibercept 2 mg every 12-weeks. Subjects will be followed every 4 weeks through week 12, and can be treated if the pre-specified criteria are met. Starting at week 12 if NV or PDR are stable or improved (as assessed by investigator) the subject will be monitored and treated at a 12-week interval through week 48. If NV or PDR are worse per the pre-specified criteria at week 12, or at any study visit thereafter, the subject will be treated monthly through the end of the study.
At week 52, aflibercept 2 mg every 4 weeks (defined as 28 days (+ 7 days) and at least 21 days between injections) for subjects with visible retinal non-perfusion. If retinal non-perfusion has completely resolved at week 72, aflibercept every 12 weeks through end of study. For subjects without retinal non-perfusion at week 52, aflibercept 2 mg every 12 weeks through the end of study.
Aflibercept: Intravitreal injection
|
|---|---|---|
|
Percentage of Subjects Who Develop Vitreous Hemorrhage
Week 52
|
2 Participants
|
1 Participants
|
|
Percentage of Subjects Who Develop Vitreous Hemorrhage
Week 100
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 52 Weeks and 100 WeeksPopulation: 3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.
Percentage of subjects treated with PRP or vitrectomy for progression of PDR from baseline to week 52 and week 100.
Outcome measures
| Measure |
Q4WKS
n=20 Participants
Aflibercept 2 mg every 4 weeks (defined as every 28 days (+ 7 days) and at least 21 days between injections) through week 48. Following week 48, aflibercept 2 mg every 12 weeks through week 96.
If NV or PDR are worse per pre-specified criteria at week 60, or at any study visit thereafter, the subject will be treated every 4 weeks through the end of the study.
Aflibercept: Intravitreal injection
|
Q12WKS
n=20 Participants
Aflibercept 2 mg every 12-weeks. Subjects will be followed every 4 weeks through week 12, and can be treated if the pre-specified criteria are met. Starting at week 12 if NV or PDR are stable or improved (as assessed by investigator) the subject will be monitored and treated at a 12-week interval through week 48. If NV or PDR are worse per the pre-specified criteria at week 12, or at any study visit thereafter, the subject will be treated monthly through the end of the study.
At week 52, aflibercept 2 mg every 4 weeks (defined as 28 days (+ 7 days) and at least 21 days between injections) for subjects with visible retinal non-perfusion. If retinal non-perfusion has completely resolved at week 72, aflibercept every 12 weeks through end of study. For subjects without retinal non-perfusion at week 52, aflibercept 2 mg every 12 weeks through the end of study.
Aflibercept: Intravitreal injection
|
|---|---|---|
|
Percentage of Subjects Treated With Pan-retinal Photocoagulation or Vitrectomy
Week 52
|
0 Participants
|
0 Participants
|
|
Percentage of Subjects Treated With Pan-retinal Photocoagulation or Vitrectomy
Week 100
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 52 Weeks and 100 WeeksPopulation: 3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study. Number analyzed at Week 52 and Week 100 differs from overall number analyzed due to inability to analyze images, lost to follow up, or deceased participants.
Percentage of subjects, at week 52 and week 100, who develop center-involving diabetic macular edema who did not have center-involving diabetic macular edema at baseline
Outcome measures
| Measure |
Q4WKS
n=20 Participants
Aflibercept 2 mg every 4 weeks (defined as every 28 days (+ 7 days) and at least 21 days between injections) through week 48. Following week 48, aflibercept 2 mg every 12 weeks through week 96.
If NV or PDR are worse per pre-specified criteria at week 60, or at any study visit thereafter, the subject will be treated every 4 weeks through the end of the study.
Aflibercept: Intravitreal injection
|
Q12WKS
n=20 Participants
Aflibercept 2 mg every 12-weeks. Subjects will be followed every 4 weeks through week 12, and can be treated if the pre-specified criteria are met. Starting at week 12 if NV or PDR are stable or improved (as assessed by investigator) the subject will be monitored and treated at a 12-week interval through week 48. If NV or PDR are worse per the pre-specified criteria at week 12, or at any study visit thereafter, the subject will be treated monthly through the end of the study.
At week 52, aflibercept 2 mg every 4 weeks (defined as 28 days (+ 7 days) and at least 21 days between injections) for subjects with visible retinal non-perfusion. If retinal non-perfusion has completely resolved at week 72, aflibercept every 12 weeks through end of study. For subjects without retinal non-perfusion at week 52, aflibercept 2 mg every 12 weeks through the end of study.
Aflibercept: Intravitreal injection
|
|---|---|---|
|
Percentage of Subjects Who Develop Center-involving Diabetic Macular Edema
Week 52
|
0 Participants
|
0 Participants
|
|
Percentage of Subjects Who Develop Center-involving Diabetic Macular Edema
Week 100
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 52 weeks and 100 weeksPopulation: 3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study. Number analyzed at Week 52 and Week 100 differs from overall number analyzed due to inability to analyze images, lost to follow up, or deceased participants.
Changes in self reported visual function utilizing the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) from baseline to week 52 and week 100. The NEI VFQ is a validated measure of patient-reported visual function measured on a scale from 0 (worst function) to 100 (best function).
Outcome measures
| Measure |
Q4WKS
n=20 Participants
Aflibercept 2 mg every 4 weeks (defined as every 28 days (+ 7 days) and at least 21 days between injections) through week 48. Following week 48, aflibercept 2 mg every 12 weeks through week 96.
If NV or PDR are worse per pre-specified criteria at week 60, or at any study visit thereafter, the subject will be treated every 4 weeks through the end of the study.
Aflibercept: Intravitreal injection
|
Q12WKS
n=20 Participants
Aflibercept 2 mg every 12-weeks. Subjects will be followed every 4 weeks through week 12, and can be treated if the pre-specified criteria are met. Starting at week 12 if NV or PDR are stable or improved (as assessed by investigator) the subject will be monitored and treated at a 12-week interval through week 48. If NV or PDR are worse per the pre-specified criteria at week 12, or at any study visit thereafter, the subject will be treated monthly through the end of the study.
At week 52, aflibercept 2 mg every 4 weeks (defined as 28 days (+ 7 days) and at least 21 days between injections) for subjects with visible retinal non-perfusion. If retinal non-perfusion has completely resolved at week 72, aflibercept every 12 weeks through end of study. For subjects without retinal non-perfusion at week 52, aflibercept 2 mg every 12 weeks through the end of study.
Aflibercept: Intravitreal injection
|
|---|---|---|
|
Changes in Visual Function Outcomes (Self Reported Visual Function)
Week 52
|
6.27 units on a scale
Standard Deviation 17.54
|
2.23 units on a scale
Standard Deviation 12.86
|
|
Changes in Visual Function Outcomes (Self Reported Visual Function)
Week 100
|
8.91 units on a scale
Standard Deviation 22.04
|
8.82 units on a scale
Standard Deviation 13.33
|
SECONDARY outcome
Timeframe: 52 weeks and 100 weeksPopulation: 3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study. Number analyzed at Week 52 and Week 100 differs from overall number analyzed due to inability to analyze images, lost to follow up, or deceased participants.
Mean change in central subfield thickness (CST) from baseline to week 52 and week 100
Outcome measures
| Measure |
Q4WKS
n=20 Participants
Aflibercept 2 mg every 4 weeks (defined as every 28 days (+ 7 days) and at least 21 days between injections) through week 48. Following week 48, aflibercept 2 mg every 12 weeks through week 96.
If NV or PDR are worse per pre-specified criteria at week 60, or at any study visit thereafter, the subject will be treated every 4 weeks through the end of the study.
Aflibercept: Intravitreal injection
|
Q12WKS
n=20 Participants
Aflibercept 2 mg every 12-weeks. Subjects will be followed every 4 weeks through week 12, and can be treated if the pre-specified criteria are met. Starting at week 12 if NV or PDR are stable or improved (as assessed by investigator) the subject will be monitored and treated at a 12-week interval through week 48. If NV or PDR are worse per the pre-specified criteria at week 12, or at any study visit thereafter, the subject will be treated monthly through the end of the study.
At week 52, aflibercept 2 mg every 4 weeks (defined as 28 days (+ 7 days) and at least 21 days between injections) for subjects with visible retinal non-perfusion. If retinal non-perfusion has completely resolved at week 72, aflibercept every 12 weeks through end of study. For subjects without retinal non-perfusion at week 52, aflibercept 2 mg every 12 weeks through the end of study.
Aflibercept: Intravitreal injection
|
|---|---|---|
|
Mean Change in Central Subfield Thickness
Week 100
|
-35.059 micrometers
Standard Deviation 27.276
|
-23.313 micrometers
Standard Deviation 31.979
|
|
Mean Change in Central Subfield Thickness
Week 52
|
-32.947 micrometers
Standard Deviation 20.961
|
-20.813 micrometers
Standard Deviation 26.684
|
SECONDARY outcome
Timeframe: 52 weeks and 100 weeksPopulation: 3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study. Number analyzed at Week 52 and Week 100 differs from overall number analyzed due to inability to analyze images, lost to follow up, or deceased participants.
Change in area of total retinal capillary non-perfusion, as assessed by the central reading center, at week 52 and week 100 compared to baseline.
Outcome measures
| Measure |
Q4WKS
n=20 Participants
Aflibercept 2 mg every 4 weeks (defined as every 28 days (+ 7 days) and at least 21 days between injections) through week 48. Following week 48, aflibercept 2 mg every 12 weeks through week 96.
If NV or PDR are worse per pre-specified criteria at week 60, or at any study visit thereafter, the subject will be treated every 4 weeks through the end of the study.
Aflibercept: Intravitreal injection
|
Q12WKS
n=20 Participants
Aflibercept 2 mg every 12-weeks. Subjects will be followed every 4 weeks through week 12, and can be treated if the pre-specified criteria are met. Starting at week 12 if NV or PDR are stable or improved (as assessed by investigator) the subject will be monitored and treated at a 12-week interval through week 48. If NV or PDR are worse per the pre-specified criteria at week 12, or at any study visit thereafter, the subject will be treated monthly through the end of the study.
At week 52, aflibercept 2 mg every 4 weeks (defined as 28 days (+ 7 days) and at least 21 days between injections) for subjects with visible retinal non-perfusion. If retinal non-perfusion has completely resolved at week 72, aflibercept every 12 weeks through end of study. For subjects without retinal non-perfusion at week 52, aflibercept 2 mg every 12 weeks through the end of study.
Aflibercept: Intravitreal injection
|
|---|---|---|
|
Change in Area of Total Retinal Capillary Non-perfusion, as Assessed by the Central Reading Center
Week 52
|
-11.994 mm^2
Standard Deviation 128.697
|
66.752 mm^2
Standard Deviation 100.546
|
|
Change in Area of Total Retinal Capillary Non-perfusion, as Assessed by the Central Reading Center
Week 100
|
141.317 mm^2
Standard Deviation 110.523
|
245.694 mm^2
Standard Deviation 132.051
|
Adverse Events
Q4WKS
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Q12WKS
Serious events: 2 serious events
Other events: 8 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Q4WKS
n=20 participants at risk
Aflibercept 2 mg every 4 weeks (defined as every 28 days (+ 7 days) and at least 21 days between injections) through week 48. Following week 48, aflibercept 2 mg every 12 weeks through week 96.
If NV or PDR are worse per pre-specified criteria at week 60, or at any study visit thereafter, the subject will be treated every 4 weeks through the end of the study.
Aflibercept: Intravitreal injection
|
Q12WKS
n=20 participants at risk
Aflibercept 2 mg every 12-weeks. Subjects will be followed every 4 weeks through week 12, and can be treated if the pre-specified criteria are met. Starting at week 12 if NV or PDR are stable or improved (as assessed by investigator) the subject will be monitored and treated at a 12-week interval through week 48. If NV or PDR are worse per the pre-specified criteria at week 12, or at any study visit thereafter, the subject will be treated monthly through the end of the study.
At week 52, aflibercept 2 mg every 4 weeks (defined as 28 days (+ 7 days) and at least 21 days between injections) for subjects with visible retinal non-perfusion. If retinal non-perfusion has completely resolved at week 72, aflibercept every 12 weeks through end of study. For subjects without retinal non-perfusion at week 52, aflibercept 2 mg every 12 weeks through the end of study.
Aflibercept: Intravitreal injection
|
|---|---|---|
|
Cardiac disorders
Worsening of Coronary Artery Disease
|
5.0%
1/20 • Number of events 1 • 52 weeks and 100 weeks
3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.
|
0.00%
0/20 • 52 weeks and 100 weeks
3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.
|
|
Cardiac disorders
Exacerbation of CHF
|
5.0%
1/20 • Number of events 1 • 52 weeks and 100 weeks
3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.
|
0.00%
0/20 • 52 weeks and 100 weeks
3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.
|
|
Endocrine disorders
Hyperglycemia
|
5.0%
1/20 • Number of events 1 • 52 weeks and 100 weeks
3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.
|
0.00%
0/20 • 52 weeks and 100 weeks
3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.
|
|
Infections and infestations
Acute Osteomyelitis
|
0.00%
0/20 • 52 weeks and 100 weeks
3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.
|
5.0%
1/20 • Number of events 1 • 52 weeks and 100 weeks
3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.
|
|
Infections and infestations
Bacteremia
|
0.00%
0/20 • 52 weeks and 100 weeks
3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.
|
5.0%
1/20 • Number of events 1 • 52 weeks and 100 weeks
3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.
|
|
Cardiac disorders
NSTEMI
|
5.0%
1/20 • Number of events 1 • 52 weeks and 100 weeks
3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.
|
0.00%
0/20 • 52 weeks and 100 weeks
3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.
|
Other adverse events
| Measure |
Q4WKS
n=20 participants at risk
Aflibercept 2 mg every 4 weeks (defined as every 28 days (+ 7 days) and at least 21 days between injections) through week 48. Following week 48, aflibercept 2 mg every 12 weeks through week 96.
If NV or PDR are worse per pre-specified criteria at week 60, or at any study visit thereafter, the subject will be treated every 4 weeks through the end of the study.
Aflibercept: Intravitreal injection
|
Q12WKS
n=20 participants at risk
Aflibercept 2 mg every 12-weeks. Subjects will be followed every 4 weeks through week 12, and can be treated if the pre-specified criteria are met. Starting at week 12 if NV or PDR are stable or improved (as assessed by investigator) the subject will be monitored and treated at a 12-week interval through week 48. If NV or PDR are worse per the pre-specified criteria at week 12, or at any study visit thereafter, the subject will be treated monthly through the end of the study.
At week 52, aflibercept 2 mg every 4 weeks (defined as 28 days (+ 7 days) and at least 21 days between injections) for subjects with visible retinal non-perfusion. If retinal non-perfusion has completely resolved at week 72, aflibercept every 12 weeks through end of study. For subjects without retinal non-perfusion at week 52, aflibercept 2 mg every 12 weeks through the end of study.
Aflibercept: Intravitreal injection
|
|---|---|---|
|
Eye disorders
Worsening Cataract
|
10.0%
2/20 • Number of events 2 • 52 weeks and 100 weeks
3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.
|
20.0%
4/20 • Number of events 4 • 52 weeks and 100 weeks
3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.
|
|
Eye disorders
Subconjunctival Hemorrhage
|
20.0%
4/20 • Number of events 4 • 52 weeks and 100 weeks
3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.
|
0.00%
0/20 • 52 weeks and 100 weeks
3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.
|
|
Eye disorders
Vitreous Hemorrhage
|
10.0%
2/20 • Number of events 2 • 52 weeks and 100 weeks
3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.
|
5.0%
1/20 • Number of events 1 • 52 weeks and 100 weeks
3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.
|
|
Ear and labyrinth disorders
Floater
|
10.0%
2/20 • Number of events 2 • 52 weeks and 100 weeks
3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.
|
5.0%
1/20 • Number of events 1 • 52 weeks and 100 weeks
3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.
|
|
Eye disorders
Photophobia
|
10.0%
2/20 • Number of events 2 • 52 weeks and 100 weeks
3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.
|
0.00%
0/20 • 52 weeks and 100 weeks
3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.
|
|
Eye disorders
Eye Pain
|
5.0%
1/20 • Number of events 1 • 52 weeks and 100 weeks
3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.
|
5.0%
1/20 • Number of events 1 • 52 weeks and 100 weeks
3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.
|
|
Eye disorders
Eye Irritation
|
10.0%
2/20 • Number of events 2 • 52 weeks and 100 weeks
3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.
|
0.00%
0/20 • 52 weeks and 100 weeks
3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.
|
|
Eye disorders
Foreign body sensation
|
5.0%
1/20 • Number of events 1 • 52 weeks and 100 weeks
3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.
|
0.00%
0/20 • 52 weeks and 100 weeks
3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.
|
|
Eye disorders
Ocular Burning
|
5.0%
1/20 • Number of events 1 • 52 weeks and 100 weeks
3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.
|
0.00%
0/20 • 52 weeks and 100 weeks
3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.
|
|
Eye disorders
Dryness
|
5.0%
1/20 • Number of events 1 • 52 weeks and 100 weeks
3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.
|
0.00%
0/20 • 52 weeks and 100 weeks
3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.
|
|
Eye disorders
Corneal Haze
|
0.00%
0/20 • 52 weeks and 100 weeks
3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.
|
5.0%
1/20 • Number of events 1 • 52 weeks and 100 weeks
3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.
|
|
Eye disorders
Acute Follicular Conjunctivitis
|
0.00%
0/20 • 52 weeks and 100 weeks
3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.
|
5.0%
1/20 • Number of events 1 • 52 weeks and 100 weeks
3 participants that were enrolled dropped out before their Week 4 visit and were replaced in the study. Thus, only 40 subjects of the original 43 were followed and analyzed in the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place