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

NCT04015180 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-10-10

No results posted yet for this study

Summary

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

Conditions

  • Retinopathy of Prematurity (ROP)

Interventions

DRUG

Eylea (Aflibercept, BAY86-5321)

Treatment administered in 20090. Solution in a sterile glass vial, Dose A, IVT injection.

PROCEDURE

Laser photocoagulation

Treatment administered in 20090. Transpupillary conventional laser ablative therapy

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
13 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-18
Primary Completion
2025-09-19
Completion
2025-09-19

Countries

  • Argentina
  • Belgium
  • Brazil
  • Bulgaria
  • Czechia
  • Greece
  • Hungary
  • Israel
  • Italy
  • Japan
  • Malaysia
  • Netherlands
  • Portugal
  • Romania
  • Russia
  • Singapore
  • Slovakia
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04015180 on ClinicalTrials.gov