Intravitreal Aflibercept for Retinal Non-Perfusion in Proliferative Diabetic Retinopathy
Condition: Proliferative Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Intervention: Aflibercept
Intervention description: Intravitreal injection
Intervention MeSH terms: Aflibercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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
    

Eligibility 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.