Phase 3
N=402
Study of the Efficacy and Safety of Intravitreal (IVT) Aflibercept for the Improvement of Moderately Severe to Severe Nonproliferative Diabetic Retinopathy (NPDR)
Nonproliferative Diabetic Retinopathy
Bottom Line
View on ClinicalTrials.gov: NCT02718326 ↗Enrolled (actual)
402
Serious AEs
31.0%
Results posted
Nov 2019
Primary outcome: Primary: Percentage of Participants Who Improved by ≥2 Steps From Baseline in the Diabetic Retinopathy Disease Severity Scale (DRSS) Score at Week 24 in the Combined 2Q16 and 2Q8 Groups — 6.0; 61.5; 55.2; 58.4 Percentage of participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Intravitreal aflibercept injection [IAI] (Drug); Sham (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Regeneron Pharmaceuticals
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Improved by ≥2 Steps From Baseline in the Diabetic Retinopathy Disease Severity Scale (DRSS) Score at Week 24 in the Combined 2Q16 and 2Q8 Groups |
6.0; 61.5; 55.2; 58.4 | <0.0001 sig |
| PRIMARY Percentage of Participants With a ≥ 2-step Change at Week 52 in Diabetic Retinopathy Severity Scale (DRSS) From Baseline |
15.0; 65.2; 79.9 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Developed a Vision-Threatening Complication Due to Diabetic Retinopathy at Week 52 |
20.3; 3.7; 3.0 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Developed Central Involved-Diabetic Macular Edema (CI-DME) at Week 52 |
25.6; 6.7; 8.2 | = 0.0002 sig |
| SECONDARY Time to Development of Any Neovascular Vision Threatening Complication (PDR/ASNV) Through Week 52 |
NA; NA; NA | — |
| SECONDARY Time to Development of Central Involved-Diabetic Macular Edema (CI-DME) Through Week 52 |
NA; NA; NA | — |
| SECONDARY Percentage of Participants Who Received Panretinal Photocoagulation (PRP), Inclusive of Participants Undergoing Vitrectomy With Endolaser, at Week 52 |
6.8; 0.7; 0.7 | 0.0096 sig |
| SECONDARY Area Under the Curve (AUC) for Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 52 |
0.5; 1.7; 1.3 | 0.0529 |
Summary
The primary objective of the study is to assess the efficacy of intravitreal (IVT) aflibercept compared to sham treatment in the improvement of moderately severe to severe nonproliferative diabetic retinopathy (NPDR).
The secondary objectives of the study are:
* To characterize the safety of IVT aflibercept in patients with moderately severe to severe NPDR
* To determine if IVT aflibercept will prevent the worsening of diabetic retinopathy and reduce the incidence of DME
* To determine the anatomic effects of IVT aflibercept in patients with moderately severe to severe NPDR
Eligibility Criteria
Key Inclusion Criteria
- Men or women ≥18 years of age with type 1 or 2 diabetes mellitus who have moderately severe to severe nonproliferative diabetic retinopathy (NPDR) [(diabetic retinopathy severity scale (DRSS) levels 47 or 53)], confirmed by the central reading center, in whom panretinal photocoagulation (PRP) can be safely deferred for at least 6 months per the investigator
- Best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better)
Key Exclusion Criteria
- Presence of diabetic macular edema (DME) threatening the center of the macula in the study eye
- Evidence of retinal neovascularization on clinical examination or Fluorescein Angiography (FA)
- Any prior focal or grid laser photocoagulation or any prior PRP in the study eye
- Any prior systemic anti-vascular endothelial growth factor (VEGF) treatment or intravitreal (IVT) anti-VEGF treatment in the study eye
- Any prior intraocular steroid injection in the study eye
- Current anterior segment neovascularization (ASNV), vitreous hemorrhage, or tractional retinal detachment visible at the screening assessments in the study eye
Note: Other inclusion/ exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT02718326). 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.