Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
2-mg Intravitreous Aflibercept · 1 trial · 2 indications
The area under the curve (units = letters·weeks) was divided by 24 weeks (units = weeks) to obtain an average change in letter score (units = letters) over the 24-weekr follow-up. Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent of \<20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.
| Arm | Type | Description |
|---|---|---|
| Intravitreous 2 mg aflibercept injections | ACTIVE_COMPARATOR | Initial injection must be given on the day of randomization. Follow-up injections will be performed as often as every 4 weeks unless criteria for deferral are met. |
| Prompt vitrectomy plus panretinal photocoagulation | ACTIVE_COMPARATOR | For the prompt vitrectomy + panretinal photocoagulation group, the vitrectomy must be scheduled to be performed within 2 weeks of randomization. Vitrectomy will be performed according to the investigator's usual routine, including pre-operative care, surgical procedure, and post-operative care, although anti-VEGF may not be given post-operatively unless there is recurrent hemorrhage. |
| Name | Type | Description |
|---|---|---|
| 2-mg Intravitreous Aflibercept Injection | DRUG | Soluble decoy receptor fusion protein that has a high binding affinity to all isoforms of VEGF as well as to placental growth factor. |
| Prompt Vitrectomy Plus Panretinal Photocoagulation | PROCEDURE | Surgical removal of the vitreous gel and associated hemorrhage, concurrent delivery of panretinal endolaser |
Inclusion Criteria: 1. Age \>= 18 years Participants \<18 years old are not being included because proliferative diabetic retinopathy is so rare in this age group that the diagnosis may be questionable. 2. Diagnosis of diabetes mellitus (type 1 or type 2) Any one of the following will be considere...
2-mg Intravitreous Aflibercept is being studied for proliferative diabetic retinopathy, including cases complicated by vitreous hemorrhage. It is an intravitreous, or eye-injected, therapy developed by Regeneron Pharmaceuticals. The program is in Phase 2 clinical development and is not yet approved for this use.
2-mg Intravitreous Aflibercept is developed by Regeneron Pharmaceuticals, Inc., which trades under the ticker REGN. Regeneron is the sponsor of the clinical program evaluating this 2-mg intravitreous formulation in proliferative diabetic retinopathy.
2-mg Intravitreous Aflibercept is in Phase 2 clinical development. It is investigational and has not been approved by the FDA for proliferative diabetic retinopathy. One Phase 2 trial has been completed, and no trials are currently active.
2-mg Intravitreous Aflibercept has been evaluated in one completed Phase 2 trial, NCT02858076, titled Anti-VEGF vs. Prompt Vitrectomy for VH From PDR. The trial enrolled 205 participants across the United States and Canada and studied proliferative diabetic retinopathy with vitreous hemorrhage.