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

Shire

Status and phase: Completed; Phase 2

Conditions: Retinopathy of Prematurity (ROP)

Treatments: Drug: rhIGF-1/rhIGFBP-3

Study type: Interventional

Funder types: Industry

Identifiers

NCT02386839

2014-003556-31 (EudraCT Number)

SHP607-201

Details and patient eligibility

About

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).

Full description

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

Enrollment: 76 patients

Sex: All

Ages: 40 to 108 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

Antecedent Standard of Care

Experimental group

Description:

Participants who were treated with standard neonatal care in study ROPP-2008-01 (NCT01096784) were enrolled in this group for assessment of rhIGF-1/rhIGFBP-3 long-term efficacy and safety outcomes.

Treatment:

Drug: rhIGF-1/rhIGFBP-3

Antecedent rhIGF-1/rhIGFBP-3

Experimental group

Description:

Participants who were treated with rhIGF-1/rhIGFBP-3 in study ROPP-2008-01 (NCT01096784) were enrolled in this group for assessment of rhIGF-1/rhIGFBP-3 long-term efficacy and safety outcomes.

Treatment:

Drug: rhIGF-1/rhIGFBP-3