Long-term Safety and Efficacy Outcome Study Comparing Children Previously Enrolled in Study ROPP-2008-01 for the Prevention of Retinopathy of Prematurity (ROP)
Completed · Phase 2
Conditions studied: Retinopathy of Prematurity (ROP)
In brief
The main purpose of this study is to evaluate the long-term efficacy and safety outcomes following short-term exposure to rhIGF-1/rhIGFBP-3 versus standard neonatal care in Study ROPP-2008-01 (NCT01096784).
Key facts
- Study ID
- NCT02386839
- Run by
- Shire
- People needed
- 76
- Starts
- 2015-03-26
- Expected to finish
- 2021-09-28
- Last updated by the study team
- 2022-05-18
Who can join
Age: 1 and older, up to 2. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Participant was randomized in Study ROPP-2008-01 Section D (NCT01096784).
- Participants 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 participant.
You may not qualify if…
- Any other condition or therapy that, in the Investigator's opinion, may pose a risk to the Participant or interfere with the participants ability to be compliant with this protocol or interfere with the interpretation of results.
- The participant or participants parent or legally authorized representative(s) is unable to comply with the protocol as determined by the Investigator.
Where it is running
- University of South Alabama Children's and Women's Hospital — Mobile, Alabama, United States
- Vidant Medical Center — Greenville, North Carolina, United States
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
- University of Wisconsin - Madison — Madison, Wisconsin, United States
- Azienda Ospedaliera Universitaria Careggi — Florence, Italy
- Istituto Giannina Gaslini-Istituto Pediatrico di Ricovero e — Genova, Italy
- University of Padua — Padua, Italy
- Policlinico Universitario Agostino Gemelli — Roma, Italy
- VU Medical Center — Amsterdam, Netherlands
- Ginekologiczno-Położniczy Szpital Kliniczny Uniwersytetu Medycznego w Poznan — Poznan, Poland
- Skanes Universitetssjukhus Lund — Lund, Sweden
- Karolinska Universitetssjukhuset Huddinge — Stockholm, Sweden
- Addenbrookes Hospital — Cambridge, United Kingdom
- St Peter's Hospital — Chertsey, United Kingdom
- Alder Hey Childrens Hospital — Liverpool, United Kingdom
- UCL EGA Institute for Women's Health — London, United Kingdom
Full record on ClinicalTrials.gov
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