MedTrace Logo

Aflibercept for Retinopathy of Prematurity - Intravitreal Injection Versus Laser Therapy

NCT04004208 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2022-05-06

Study results available
· View outcomes & findings →

Summary

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.

Conditions

  • Retinopathy of Prematurity (ROP)

Interventions

DRUG

Eylea (Aflibercept, BAY86-5321)

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

PROCEDURE

Laser photocoagulation

Transpupillary conventional laser ablative therapy

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
32 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-25
Primary Completion
2021-02-12
Completion
2021-02-12
FDA Drug
Yes

Countries

  • Argentina
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Czechia
  • Greece
  • Hong Kong
  • Hungary
  • Israel
  • Italy
  • Japan
  • Malaysia
  • Netherlands
  • Poland
  • 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 NCT04004208 on ClinicalTrials.gov