Study of a High-Dose Aflibercept in Participants With Diabetic Eye Disease

Conditions

• Diabetic Macular Edema
• Type 1 Diabetes Mellitus
• Type 2 Diabetes Mellitus

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• aflibercept — DRUG
  Intravitreally (IVT) administered as a liquid formulation in a vial
• High-dose aflibercept — DRUG
  Intravitreally (IVT) administered as a liquid formulation in a vial

Study Details

The primary objective of the study is to determine if treatment with high-dose aflibercept (HD) at intervals of 12 or 16 weeks provides non-inferior best corrected visual acuity (BCVA) compared to aflibercept dosed every 8 weeks. The secondary objectives of the study are as follows: * To determine the effect of HD vs. aflibercept on anatomic and other visual measures of response * To evaluate the safety, immunogenicity, and pharmacokinetics (PK) of aflibercept

Key Dates

Start date

Jun 29, 2020

Status verified

Jul 2025

Primary completion

May 30, 2022

Completion

Jun 18, 2024

Study Design

Enrollment

660 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: aflibercept Q8
  Administered every 8 weeks after a loading phase
• Experimental: High-Dose aflibercept Q12
  Administered every 12 weeks after a loading phase
• Experimental: High-Dose aflibercept Q16
  Administered every 16 weeks after a loading phase

Primary Outcome Measure

Change From Baseline in Best Corrected Visual Acuity (BCVA) (Early Treatment Diabetic Retinopathy Study [ETDRS] Letter Score) in the Study Eye at Week 48 [ Time Frame: Baseline, Week 48 ]

Locations (84)

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