ong-term Outcome of Children Enrolled in Study ROPP-2008-01 Previously Treated with rhIGF-1/rhIGFBP-3 for the Prevention of Retinopathy of Prematurity (ROP) or Who Received Standard Neonatal Care
Phase 2
Completed
- Conditions
- Retinopathy of prematurityROP10047060
- Registration Number
- NL-OMON42024
- Lead Sponsor
- Shire
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
Inclusion Criteria
1. Subject was randomized in Study ROPP-2008-01, Section D
2. Subject*s parent or legally authorized representative(s) must provide written informed consent prior to performing any study-related activities. Study-related activities are any procedures that would not have been performed during normal management of the subject.
Exclusion Criteria
1. Any other condition or therapy that, in the Investigator*s opinion, may pose a risk to the subject or interfere with the subject*s ability to be compliant with this protocol or interfere with the interpretation of results
2. The subject or subject*s parent or legally authorized representative(s) is unable to comply with the protocol as determined by the Investigator
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy endpoints of this study are:<br /><br>* Visual acuity as assessed by an age appropriate method<br /><br>* Ocular alignment and ocular motor examination in primary gaze and in as many<br /><br>of 9 positions of gaze as possible as assessed by corneal light reflex and by<br /><br>the cover test<br /><br>* Assessment of nystagmus by observation<br /><br>* Refraction as assessed by retinoscopy with cycloplegia<br /><br>* Stereoacuity as assessed with the Lang Stereotest</p><br>
- Secondary Outcome Measures
Name Time Method