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
- Conditions
- Retinopathy of Prematurity (ROP)MedDRA version: 18.1Level: PTClassification code 10038923Term: RetinopathySystem Organ Class: 10015919 - Eye disordersTherapeutic area: Body processes [G] - Ocular Physiological Phenomena [G14]
- Registration Number
- EUCTR2014-003556-31-IT
- Lead Sponsor
- PREMACURE AB, A MEMBER OF SHIRE GROUP OF COMPANIES
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 76
Each subject must meet the following criteria to be enrolled in this
study.
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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 120
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 who meet any of the following criteria will be excluded from the study.
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
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method