Extension study to evaluate the long-term outcomes of subjects in study 20090

Phase 1

• Conditions: Retinopathy of prematurity; MedDRA version: 20.1Level: PTClassification code: 10038933Term: Retinopathy of prematurity Class: 100000004853; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: CTIS2023-504207-89-00
• Lead Sponsor: Bayer AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-29
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

Subject was treated in Study 20090, Age less than 13 months of chronological age, Signed informed consent from parent(s)/legally authorized representative(s), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol

Exclusion Criteria

Subject has a medical condition preventing participation in the study, or performance of study procedures

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate long-term safety outcomes and visual function of subjects included in Study 20090 for treatment for retinopathy of prematurity (ROP);Secondary Objective: To describe the visual function and overall development of subjects included in Study 20090 for treatment for ROP;Primary end point(s): Binocular best-corrected visual acuity in Snellen equivalent score at 5 years of age.