Intravitreal Aflibercept for Retinal Non-Perfusion in Proliferative Diabetic Retinopathy

Completed · Phase 2

Conditions studied: Proliferative Diabetic Retinopathy

In brief

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 capillary non-perfusion (RNP) associated with proliferative diabetic retinopathy (PDR). * Assess the safety and tolerability of IAI for the treatment of proliferative diabetic retinopathy by evaluating the incidence and severity of ocular and systemic adverse events through week 52 * Change in area of retinal capillary non-perfusion, as assessed by central reading center, from baseline through week 52

Key facts

Study ID

NCT02863354

Run by

Charles C Wykoff, PhD, MD

People needed

43

Starts

2016-08-01

Expected to finish

2019-05-01

Last updated by the study team

2021-05-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type 1 or type 2 diabetes mellitus
• BCVA ETDRS > 20/400 in the study eye
• Willing and able to comply with clinic visits and study-related procedures
• Provide signed informed consent
• Substantial non perfusion (defined as greater than 20 disc areas), as assessed by the investigator
• Early PDR, as assessed by the investigator, with no vitreous hemorrhage*
• Early PDR is defined in which PRP can safely be deferred and vitreous hemorrhage that does not obscure the application of PRP

You may not qualify if…

• Any prior systemic anti-VEGF (anti vascular endothelial growth factor) or IVT anti-VEGF treatment in the study eye,
• SD-OCT (Spectral Domain Optical Coherence Tomography) central subfield thickness measurement of > 320 µm, in the study eye
• Evidence of infectious ocular infection, in the study eye, at time of screening
• History of vitreoretinal surgery in the study eye
• Any prior Panretinal laser photocoagulation (PRP) in the study eye
• Current vitreous hemorrhage obscuring retinal imaging in the study eye
• Cataract surgery in the study eye within 4 weeks of Day 0
• Uncontrolled blood pressure (defined as > 180/110 mm Hg systolic/diastolic, while seated)
• Significant renal disease defined as a history of chronic renal failure requiring dialysis or renal transplant
• Tractional Retinal Detachment threatening the macula in the study eye
• Corticosteroid treatment (intravitreal or peribulbar) in the study eye within 12 weeks of screening
• Pregnant or breast-feeding women
• Sexually active men* or women of childbearing potential who are unwilling to practice adequate contraception during the study. Adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device (IUD); bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly.
• Contraception is not required for men with documented vasectomy.

Where it is running

• Retina Consultants of Houston/The Medical Center — Houston, Texas, United States
• Retina Consultants of Houston/Katy office — Katy, Texas, United States
• Retina Consultants of Houston — Kingwood, Texas, United States
• Retina Consultants of Houston — The Woodlands, Texas, United States

Full record on ClinicalTrials.gov

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