Extension study to evaluate the long-term outcomes of subjects in study 20090
- Conditions
- Retinopathy of prematurityMedDRA version: 20.1Level: PTClassification code 10038933Term: Retinopathy of prematuritySystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2018-003180-54-BG
- Lead Sponsor
- Bayer AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 102
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
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
- Secondary Outcome Measures
Name Time Method