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 used for the treatment of proliferative diabetic retinopathy, including cases complicated by vitreous hemorrhage. It is an intravitreally administered therapy developed by Regeneron Pharmaceuticals, Inc. and studied in a Phase 2 clinical trial in the United States and Canada.
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 therapy in proliferative diabetic retinopathy.
2-mg Intravitreous Aflibercept is in Phase 2 clinical development. It is an investigational therapy and has not been approved by the FDA. The Phase 2 trial has been completed, and no active trials are currently listed for this asset.
2-mg Intravitreous Aflibercept has been studied in one Phase 2 clinical trial, NCT02858076, titled Anti-VEGF vs. Prompt Vitrectomy for VH From PDR. The trial enrolled 205 participants with proliferative diabetic retinopathy and vitreous hemorrhage across the United States and Canada and has been completed.
2-mg Intravitreous Aflibercept has received a PRIORITY_REVIEW designation from the FDA. The therapy remains investigational and is in Phase 2 clinical development for proliferative diabetic retinopathy.