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The RECOVERY trial will assess the safety and tolerability of 2 mg intravitreal aflibercept injections (IAI) given monthly (Q4WK) or every 12 weeks (Q12WK) for the treatment of retinal non-perfusion (RNP) associated with proliferative diabetic retinopathy (PDR) primarily assessed through retinal capillary non-perfusion.
The investigational product is intravitreal aflibercept injection, which will be supplied by Regeneron Pharmaceuticals, Inc. in sterile vials for intravitreal (IVT) injection. Vials must be used (defined as entered with needle) only once. All drug supplies are to be kept under recommended storage conditions.
The injection volume will be 50μL (0.05 mL) and will be administered to the subjects by IVT injection.
Study eyes will be assigned randomly (1:1 ratio) to one of the following 2 treatment arms:
- Q4WKS- aflibercept 2 mg every 4 weeks (defined as every 28 days + 7 days and at least 21 days between injections).
- 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. If NV (neovascularization) 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.
Pre-specified criteria (subject must meet at least one criterion which must be documented with imaging):
1. Increased neovascularization
2. Decrease in BCVA by 5 or more letters due to progressive DME (diabetic macular edema) or PDR
3. Worsening central subfield diabetic macular edema causing vision loss, with principal investigator or other delegated investigator confirmation
4. Total area of retinal ischemia increases by 10% as determined by the central reading center
Rescue Treatment At any point throughout the study, for either treatment arm, if PDR progresses despite 3 monthly IAI, a fluorescein angiogram will be performed to evaluate PDR progression. PRP will only be permitted after confirmation of PDR progression with the primary
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Proliferative Diabetic Retinopathy
Retina Consultants of Houston/The Medical Center
Not yet recruiting
Greater Houston Retina Research
Published on BioPortfolio: 2016-08-12T08:53:21-0400
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