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Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity

NCT04101721 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2023-07-20

Study results available
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Summary

The primary objective of the study is to assess the efficacy of aflibercept compared to laser in patients diagnosed with retinopathy of prematurity (ROP). The secondary objectives of the study are to assess the need for a second treatment modality, to assess the recurrence of ROP in the study and to assess the safety and tolerability of aflibercept.

Conditions

  • Retinopathy of Prematurity

Interventions

DRUG

aflibercept

Administered IVT

PROCEDURE

laser photocoagulation

Transpupillary conventional laser will be administered according to standard local procedures.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-30
Primary Completion
2022-08-18
Completion
2022-08-18
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Colombia
  • Czechia
  • Hungary
  • Romania
  • Russia
  • Slovakia
  • South Korea
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
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 NCT04101721 on ClinicalTrials.gov