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

Phase 1

• Conditions: Retinopathy of prematurity; MedDRA version: 20.1 Level: PT Classification code 10038933 Term: Retinopathy of prematurity System Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2018-003180-54-DE
• Lead Sponsor: Bayer AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-16
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 102

Inclusion Criteria

Subjects are eligible to be included in the study only if both of the following criteria apply:
1.Subject was treated in Study 20090
2.Age less than 13 months of chronological age
3.Signed informed consent from parent(s)/legally authorized representative(s) as described in Section 10.1.3 of the clinical trial protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol

Are the trial subjects under 18? yes
Number of subjects for this age range: 102
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects are excluded from the study if the following criterion applies:
Medical Conditions
1. Subject has a 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;Timepoint(s) of evaluation of this end point: at 5 years of age