Aflibercept for Retinopathy of Prematurity - Intravitreal Injection Versus Laser Therapy

Sponsor
Bayer
Study ID
NCT04004208
Phase
PHASE3
Status
Completed

Conditions

  • Retinopathy of Prematurity (ROP)

Eligibility Criteria

Sex
ALL
Age
N/A - 32 Weeks
Healthy Volunteers
Not accepted

Interventions

  • Eylea (Aflibercept, BAY86-5321) — DRUG
    Solution in a sterile glass vial, Dose A, IVT injection.
  • Laser photocoagulation — PROCEDURE
    Transpupillary conventional laser ablative therapy

Study Details

The purpose of this study is to demonstrate how well aflibercept works in babies with ROP, comparing it with laser therapy. The study also has the objective to demonstrate how safe aflibercept is when used in babies, and describe how the drug moves into, through and out of the body.

Key Dates

Start date
Sep 25, 2019
Status verified
May 2022
Primary completion
Feb 12, 2021
Completion
Feb 12, 2021

Study Design

Enrollment
113 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Aflibercept arm
    Subjects randomized to aflibercept will receive a intravitreal (IVT) injection of Dose A aflibercept per eligible eye at baseline and, if needed, up to a defined number of additional injections in each eye.
  • Active Comparator: Laser photocoagulation arm
    Subjects randomized to laser photocoagulation will receive treatment in each eligible eye at baseline. Retreatments may be administered if needed.

Primary Outcome Measure

Proportion of Participants With Absence of Active ROP and Unfavorable Structural Outcomes [ Time Frame: At 24 weeks after starting study treatment ]

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