ROP Phase-II
Research type
Research Study
Full title
Determination of the rhIGF-I/rhIGFBP-3 Dose; Administered as a Continuous Infusion, Required to Establish and Maintain Longitudinal SErum IGF-I Levels within Physiological Levels in Premature Infants, to prevent Retinopathy of Prematurity A Phase II, Randomized Controlled, Assessor-Blind, Dose-Confirming, Pharmacokinetic, Safety and Efficacy, Multicenter Study
IRAS ID
146199
Contact name
M Turner
Contact email
Sponsor organisation
Premacure AB, A member of the Shire Group of Companies
Eudract number
2007-007872-40
Research summary
Premature babies can develop a condition called “retinopathy of prematurity” (abnormal growth of blood vessels in the retina, “ROP”), the most common cause of blindness in children in the developed world. Existing treatments can reduce blindness by 25%, but often result in less sharp vision. One cause of ROP may be the low levels of a substance called insulin like growth factor-I (IGF-1) in the days after premature birth. Low levels of IGF-1 have been found in babies who develop ROP. The effects of IGF-1 depend on a balance between IGF-1 and a substance called insulin like growth factor binding protein-3 (IGFBP-3). The purpose of this research study is to investigate if recombinant human (rh)IGF 1/rhIGFBP-3 can protect infants born prematurely from the vision-threatening eye disorder ROP, compared to a group of infants that receives standard neonatal care (control group). The study will include 120 patients.
The parents/guardians of the premature infants are consented within 24 hours of birth. After birth babies who meet the inclusion criteria are randomized 1:1 to the treatment group or control group. The serum concentration of the study drug will be monitored to make sure the right amount of IGF-1 is present. The infusion of study drug in the treatment group will last from birth to 29 weeks +6 days, as the infant should be producing sufficient IGF-1 themselves at that stage. Patients are followed until 40 weeks ±4 days postmenstrual age. Appropriate blood samples will be taken and adverse events and additional medication administered will be recorded.
Doctors treating the patients know which treatment group the baby is randomized to. The primary outcome, the severity of ROP, is measured by doctors who do not know if patients have been treated with rhIGF-1/rhIGFBP-3. The study lasts for 13 months (first patient in to last patient out).REC name
North West - Haydock Research Ethics Committee
REC reference
14/NW/0065
Date of REC Opinion
18 Mar 2014
REC opinion
Further Information Favourable Opinion