Extension Study to Evaluate the Long-term Outcomes of Subjects in Study 20090

Sponsor
Bayer
Study ID
NCT04015180
Phase
PHASE3
Status
Completed

Conditions

  • Retinopathy of Prematurity (ROP)

Eligibility Criteria

Sex
ALL
Age
N/A - 13 Months
Healthy Volunteers
Not accepted

Interventions

  • Eylea (Aflibercept, BAY86-5321) — DRUG
    Treatment administered in 20090. Solution in a sterile glass vial, Dose A, IVT injection.
  • Laser photocoagulation — PROCEDURE
    Treatment administered in 20090. Transpupillary conventional laser ablative therapy

Study Details

This is a follow-up study to evaluate the long term outcome of babies treated in the FIREFLEYE study.

Key Dates

Start date
Mar 18, 2020
Status verified
Oct 2025
Primary completion
Sep 19, 2025
Completion
Sep 19, 2025

Study Design

Enrollment
100 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Aflibercept arm
    No study treatment will be administered. The treatments to be evaluated in this study were administered in Study 20090.
  • Active Comparator: Laser photocoagulation arm
    No study treatment will be administered. The treatments to be evaluated in this study were administered in Study 20090.

Primary Outcome Measure

Binocular best-corrected visual acuity in Snellen equivalent [ Time Frame: At 5 years of age. ]

Related Studies