Trial Outcomes & Findings for Aflibercept Injection for Proliferative Diabetic Retinopathy (NCT NCT01805297)
NCT ID: NCT01805297
Last Updated: 2023-12-27
Results Overview
Percentage of patients who had no vitreous hemorrhage before or at week 24
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
24 weeks
Results posted on
2023-12-27
Participant Flow
Participant milestones
| Measure |
Vitrectomy With Aflibercept Injection
Preoperative 2.0mg intravitreal aflibercept and vitrectomy with intraoperative 2.0mg intravitreal aflibercept injection.
Intravitreal Aflibercept Injection: One time 2.0mg aflibercept injection, following pars plana vitrectomy.
|
Standard Vitrectomy
Preoperative 2.0mg intravitreal aflibercept and standard of care vitrectomy.
Standard Vitrectomy: Surgical intervention
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optical Coherence Tomography performed only as visualization permitted
Baseline characteristics by cohort
| Measure |
Vitrectomy With Aflibercept Injection
n=6 Participants
Preoperative 2.0mg intravitreal aflibercept and vitrectomy with intraoperative 2.0mg intravitreal aflibercept injection.
Intravitreal Aflibercept Injection: One time 2.0mg aflibercept injection, immediately following pars plana vitrectomy.
|
Standard Vitrectomy
n=6 Participants
Preoperative 2.0mg intravitreal aflibercept and standard of care vitrectomy.
Standard Vitrectomy: Surgical intervention
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
11 Participants
n=12 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=12 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
5 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
7 Participants
n=12 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=12 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
9 Participants
n=12 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=12 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=6 Participants
|
6 participants
n=6 Participants
|
12 participants
n=12 Participants
|
|
Mean visual acuity
|
13.8 number of letters read on ETDRS Chart
n=6 Participants
|
17.7 number of letters read on ETDRS Chart
n=6 Participants
|
15.9 number of letters read on ETDRS Chart
n=12 Participants
|
|
Intraocular pressure
|
14 mmHg
n=6 Participants
|
11.2 mmHg
n=6 Participants
|
12.6 mmHg
n=12 Participants
|
|
Central retinal thickness
|
304 Microns
n=1 Participants • Optical Coherence Tomography performed only as visualization permitted
|
305 Microns
n=1 Participants • Optical Coherence Tomography performed only as visualization permitted
|
304.5 Microns
n=2 Participants • Optical Coherence Tomography performed only as visualization permitted
|
PRIMARY outcome
Timeframe: 24 weeksPercentage of patients who had no vitreous hemorrhage before or at week 24
Outcome measures
| Measure |
Vitrectomy With Aflibercept Injection
n=6 Participants
Preoperative 2.0mg intravitreal aflibercept and vitrectomy with intraoperative 2.0mg intravitreal aflibercept injection.
Intravitreal Aflibercept Injection: One time 2.0mg aflibercept injection, following pars plana vitrectomy.
|
Standard Vitrectomy
n=6 Participants
Preoperative 2.0mg intravitreal aflibercept and standard of care vitrectomy.
Standard Vitrectomy: Surgical intervention
|
|---|---|---|
|
Rate of Resolved Post-operative Vitreous Hemorrhage.
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Patients who completed 24 week visit
Change in visual acuity measured using "Early Treatment of Diabetic Retinopathy Study" visual acuity charts and letter score difference from baseline to 6 month. A greater number indicates a higher increase in vision from the baseline score. A negative number would indicate that vision decreased.
Outcome measures
| Measure |
Vitrectomy With Aflibercept Injection
n=4 Participants
Preoperative 2.0mg intravitreal aflibercept and vitrectomy with intraoperative 2.0mg intravitreal aflibercept injection.
Intravitreal Aflibercept Injection: One time 2.0mg aflibercept injection, following pars plana vitrectomy.
|
Standard Vitrectomy
n=3 Participants
Preoperative 2.0mg intravitreal aflibercept and standard of care vitrectomy.
Standard Vitrectomy: Surgical intervention
|
|---|---|---|
|
Mean Change in Visual Acuity
|
56.75 Number of letters Read
Interval 0.0 to 100.0
|
41.67 Number of letters Read
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: 24 weeksOutcome measures
| Measure |
Vitrectomy With Aflibercept Injection
n=6 Participants
Preoperative 2.0mg intravitreal aflibercept and vitrectomy with intraoperative 2.0mg intravitreal aflibercept injection.
Intravitreal Aflibercept Injection: One time 2.0mg aflibercept injection, following pars plana vitrectomy.
|
Standard Vitrectomy
n=6 Participants
Preoperative 2.0mg intravitreal aflibercept and standard of care vitrectomy.
Standard Vitrectomy: Surgical intervention
|
|---|---|---|
|
Need for Any Additional Surgical Intervention.
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Due to lack of clear view due to vitreous Hemorrhage, all but 2 patients were unable to have optical coherence tomography at baseline, and one these was lost to follow up. For this reason, data collected for the few patients who were able to have the test was not analyzed
The amount of thickness change in microns from baseline to 6 month visit. A positive number indicates an increase in thickness and a negative number would indicate a decrease in thickness.
Outcome measures
| Measure |
Vitrectomy With Aflibercept Injection
Preoperative 2.0mg intravitreal aflibercept and vitrectomy with intraoperative 2.0mg intravitreal aflibercept injection.
Intravitreal Aflibercept Injection: One time 2.0mg aflibercept injection, following pars plana vitrectomy.
|
Standard Vitrectomy
n=1 Participants
Preoperative 2.0mg intravitreal aflibercept and standard of care vitrectomy.
Standard Vitrectomy: Surgical intervention
|
|---|---|---|
|
Changes in Mean Central Retinal Thickness.
|
—
|
20 Microns
|
Adverse Events
Vitrectomy With Aflibercept Injection
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Standard Vitrectomy
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vitrectomy With Aflibercept Injection
n=6 participants at risk
Preoperative 2.0mg intravitreal aflibercept and vitrectomy with intraoperative 2.0mg intravitreal aflibercept injection.
Intravitreal Aflibercept Injection: One time 2.0mg aflibercept injection, following pars plana vitrectomy.
|
Standard Vitrectomy
n=6 participants at risk
Preoperative 2.0mg intravitreal aflibercept and standard of care vitrectomy.
Standard Vitrectomy: Surgical intervention
|
|---|---|---|
|
General disorders
Headache
|
16.7%
1/6 • Number of events 1 • 6 months
|
50.0%
3/6 • Number of events 3 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Broken Rib
|
0.00%
0/6 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
Eye disorders
Post operative ocular pain
|
50.0%
3/6 • Number of events 3 • 6 months
|
66.7%
4/6 • Number of events 4 • 6 months
|
|
Eye disorders
descemet's folds
|
0.00%
0/6 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/6 • 6 months
|
33.3%
2/6 • Number of events 2 • 6 months
|
|
Eye disorders
Subconjunctival Hemorrhage
|
33.3%
2/6 • Number of events 2 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
Eye disorders
vitreous haze
|
16.7%
1/6 • Number of events 1 • 6 months
|
0.00%
0/6 • 6 months
|
|
Eye disorders
cataract
|
0.00%
0/6 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
Eye disorders
Optic disc pallor
|
0.00%
0/6 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
Eye disorders
visual disturbance
|
16.7%
1/6 • Number of events 1 • 6 months
|
0.00%
0/6 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • Number of events 2 • 6 months
|
0.00%
0/6 • 6 months
|
|
Eye disorders
vitreous hemorrhage
|
16.7%
1/6 • Number of events 1 • 6 months
|
0.00%
0/6 • 6 months
|
|
Eye disorders
photophobia
|
16.7%
1/6 • Number of events 1 • 6 months
|
0.00%
0/6 • 6 months
|
|
General disorders
tooth decay
|
16.7%
1/6 • Number of events 1 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
|
General disorders
tongue injury
|
16.7%
1/6 • Number of events 1 • 6 months
|
0.00%
0/6 • 6 months
|
|
Eye disorders
ocular irritation
|
0.00%
0/6 • 6 months
|
16.7%
1/6 • Number of events 1 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place