Phase 2
N=43
Intravitreal Aflibercept for Retinal Non-Perfusion in Proliferative Diabetic Retinopathy
Proliferative Diabetic Retinopathy
Bottom Line
View on ClinicalTrials.gov: NCT02863354 ↗Enrolled (actual)
43
Serious AEs
10.0%
Results posted
Apr 2021
Primary outcome: Primary: Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Aflibercept (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Charles C Wykoff, PhD, MD
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 |
0; 0; 0; 0 | — |
| SECONDARY Change in Early Treatment of Diabetic Retinopathy Severity Best Corrected Visual Acuity |
4.26; 4.53; 4.06; 8.88 | — |
| SECONDARY Change in Area of Retinal Capillary Non-perfusion Within the Macula |
0.048; 0.217; 2.627; 0.940 | — |
| SECONDARY Change in Area of Retinal Capillary Non-perfusion Outside of the Macula |
182.467; 240.472; 342.651; 387.204 | — |
| SECONDARY Percentage of Subjects With Neovascularization Regression |
17; 18; 17; 15 | — |
| SECONDARY Percentage of Subjects With Increased Neovascularization |
1; 0; 0; 0 | — |
| SECONDARY Percentage of Subjects Who Develop Vitreous Hemorrhage |
2; 1; 4; 1 | — |
| SECONDARY Percentage of Subjects Treated With Pan-retinal Photocoagulation or Vitrectomy |
0; 0; 0; 0 | — |
| SECONDARY Percentage of Subjects Who Develop Center-involving Diabetic Macular Edema |
0; 0; 0; 0 | — |
| SECONDARY Changes in Visual Function Outcomes (Self Reported Visual Function) |
6.27; 2.23; 8.91; 8.82 | — |
| SECONDARY Mean Change in Central Subfield Thickness |
-32.947; -20.813; -35.059; -23.313 | — |
| SECONDARY Change in Area of Total Retinal Capillary Non-perfusion, as Assessed by the Central Reading Center |
-11.994; 66.752; 141.317; 245.694 | — |
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
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02863354). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.