Long-term Safety and Efficacy Outcome Study Comparing Children Previously Enrolled in Study ROP-2008-01 for the Prevention of Retinopathy of Prematurity (ROP)

• Status: Active, not recruiting
• Trial end date: 2021-09-30
• Target enrollment: 0
• Participant gender: All

Summary

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 (Section D) (NCT01096784).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shire
• Treatments: Mecasermin

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.