Intravitreal Aflibercept for Retinal Non-Perfusion in Proliferative Diabetic Retinopathy

• Status: Completed
• Trial end date: 2019-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charles C Wykoff, PhD, MD
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Aflibercept

Criteria

Inclusion Criteria:

1. Type 1 or type 2 diabetes mellitus

2. BCVA ETDRS > 20/400 in the study eye

3. Willing and able to comply with clinic visits and study-related procedures

4. Provide signed informed consent

5. Substantial non perfusion (defined as greater than 20 disc areas), as assessed by the investigator

6. 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

Exclusion Criteria:

1. Any prior systemic anti-VEGF (anti vascular endothelial growth factor) or IVT anti-VEGF treatment in the study eye,

2. SD-OCT (Spectral Domain Optical Coherence Tomography) central subfield thickness measurement of > 320 µm, in the study eye

3. Evidence of infectious ocular infection, in the study eye, at time of screening

4. History of vitreoretinal surgery in the study eye

5. Any prior Panretinal laser photocoagulation (PRP) in the study eye

6. Current vitreous hemorrhage obscuring retinal imaging in the study eye

7. Cataract surgery in the study eye within 4 weeks of Day 0

8. Uncontrolled blood pressure (defined as > 180/110 mm Hg systolic/diastolic, while seated)

9. Significant renal disease defined as a history of chronic renal failure requiring dialysis or renal transplant

10. Tractional Retinal Detachment threatening the macula in the study eye

11. Corticosteroid treatment (intravitreal or peribulbar) in the study eye within 12 weeks of screening

12. Pregnant or breast-feeding women

13. 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.