Study of the Efficacy and Safety of Intravitreal (IVT) Aflibercept for the Improvement of Moderately Severe to Severe Nonproliferative Diabetic Retinopathy (NPDR)

Conditions

• Nonproliferative Diabetic Retinopathy

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Intravitreal aflibercept injection [IAI] — DRUG
• Sham — DRUG

Study Details

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

Key Dates

Start date

Mar 29, 2016

Status verified

Jul 2020

Primary completion

Aug 6, 2018

Completion

Jul 16, 2019

Study Design

Enrollment

402 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Dosing regimen 1
  Participants will receive IVT aflibercept dosing regimen 1
• Experimental: Dosing regimen 2
  Participants will receive IVT aflibercept dosing regimen 2
• Sham Comparator: Dosing regimen 3
  Participants will receive matching sham injections

Primary Outcome Measure

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 [ Time Frame: At Week 24 ]

Locations (71)

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