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 proliferative diabetic retinopathy, a complication of diabetes that can cause vision loss. It is administered as an injection into the eye and is being studied for its ability to treat this condition.
2-mg Intravitreous Aflibercept targets vascular endothelial growth factor, a protein that promotes abnormal blood vessel growth in the retina. By blocking this factor, the drug aims to reduce the progression of proliferative diabetic retinopathy.
2-mg Intravitreous Aflibercept is developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company. Regeneron is publicly traded on the Nasdaq under the ticker symbol REGN.
2-mg Intravitreous Aflibercept is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA for the treatment of proliferative diabetic retinopathy.
2-mg Intravitreous Aflibercept has been studied in a completed Phase 2 trial with the identifier NCT02858076. This trial enrolled 205 participants with proliferative diabetic retinopathy and vitreous hemorrhage, and it was conducted in the United States and Canada.
2-mg Intravitreous Aflibercept is a specific formulation and dosage of aflibercept, a medication that blocks vascular endothelial growth factor. It is administered intravitreously, meaning directly into the eye, at a dose of 2 milligrams.