An extension study to evaluate the long-term outcomes of subjects who received treatment for retinopathy of prematurity in Study 20090

Phase 3

Completed

Conditions: retinopathy of prematurity
ROP
10047060

Registration Number: NL-OMON49661

Lead Sponsor: Bayer

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 2

Inclusion Criteria

Subjects are eligible to be included in the study only if 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

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: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Binocular best-corrected visual acuity in Snellen equivalent at 5 years of<br /><br>age.<br /><br>- Proportion of subjects with ocular AEs and SAEs up to 5 years of age.<br /><br>- Proportion of subjects with systemic AEs and SAEs up to 5 years of age.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Proportion of subjects developing unfavorable ocular structural outcome at<br /><br>1,3 and 5 years of age. Unfavorable ocular structural outcome<br /><br>include: retinal detachment, macular dragging, macular fold, retrolental<br /><br>opacity.<br /><br>- Proportion of subjects with absence of active ROP at 1 year of age.<br /><br>- Proportion of subjects with unfavorable structural outcomes at 1 year of age.<br /><br>- Best-corrected visual acuity in each eye at 3 and 5 years of age.<br /><br>- Refractive spherical equivalent in each eye at 3 and 5 years of age.<br /><br>- Neurodevelopmental outcomes using standardized development tests (BSID-III,<br /><br>DAS-II, WPPSI-IV, VABS-II) at 2 and 5 years of age.<br /><br>- Proportion of subjects with recurrence of ROP at 3 and 5 years of age.<br /><br>- Proportion of subjects requiring treatment for ROP up to 5 years of age.<br /><br>- Proportion of subjects requiring ophthalmological treatment up to 5 years of<br /><br>age.</p><br>