IGF-1/IGFBP3 Prevention of Retinopathy of Prematurity

What Was Tested

The trial (phase 2) is built around IGF-1 LR3 and Mecasermin (rhIGF-1).

It had two arms (groups): rhIGF-I/rhIGFBP-3 (active comparator) and Control (no intervention).

Continuous IV Infusion.

The comparator group will receive no treatment with rhIGF-1/rhIGFBP-3.

The registry classes the interventions as drug.

More on the Plan

When preterm infants are deprived of their natural intrauterine environment they lose access to important factors, normally found in utero, such as proteins, growth factors, and cytokines.

In utero these biological factors are introduced to the fetus via placental absorption or ingestion from amniotic fluid.

Deprivation of such factors is likely to cause inhibition or improper stimulation of important pathways, which in the case of the eye may cause abnormal retinal vascular growth, the hallmark of retinopathy of prematurity (ROP).

Retinopathy of prematurity is the major cause of blindness in children in the developed and developing world, despite the availability of current treatment of late-stage ROP.

Who Took Part

The registry lists 121 actual participants took part.

It was open to people of any sex aged up to 1 Day.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Signed informed consent from parents/guardians;.

The full record lists 2 inclusion and 10 exclusion criteria; among the exclusions: subjects born small for gestational age (sga), ie, body weight at birth \<-2 standard deviation score (sds) (study section a only); detectable gross malformation; known or suspected chromosomal abnormality, genetic disorder, or syndrome, according to the investigator's opinion.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

The participants were allocated by chance, so the IGF-1 LR3 group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Only one side, usually the participants, was kept unaware of whether IGF-1 LR3 was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2010-06-18 with completion listed for 2016-03-30.

It ran at 24 sites in United States (8), United Kingdom (7), Italy (4), Poland (2), Sweden (2) and Netherlands (1).

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Severity of Retinopathy of Prematurity (ROP) as Compared to the Severity of ROP in an Untreated Control Population (time frame: End of study).

It also tracked 13 secondary outcomes, for example Time to Discharge From Neonatal Intensive Care (TDNIC), Number of Participants With Bronchopulmonary Dysplasia (BPD), Rate of Change in Body Weight, Rate of Change in Length, Rate of Change in Head Circumference and Brain Development Assessed by Brain Volume at 40 Weeks PMA/EOS.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of IGF-1 LR3 and Mecasermin (rhIGF-1) in 121 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the IGF-1 LR3 compound page and the Mecasermin (rhIGF-1) compound page, all human trials.