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

What Was Tested

This registered phase 2 trial tested Mecasermin (rhIGF-1).

It had two arms (groups): Antecedent Standard of Care (experimental) and Antecedent rhIGF-1/rhIGFBP-3 (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 76 actual participants took part.

It was open to people of any sex aged from 40 Weeks up to 108 Weeks.

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

Examples of who could join: Participant was randomized in Study ROPP-2008-01 Section D (NCT01096784).

The full record lists 2 inclusion and 2 exclusion criteria; among the exclusions: the participant or participants parent or legally authorized representative(s) is unable to comply with the protocol as determined by the investigator.

How the Study Was Run

The set-up was single-group and open-label.

Nothing was hidden in this open-label Mecasermin (rhIGF-1) study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2015-03-26 with completion listed for 2021-09-28.

It ran at 16 sites in United States (4), Italy (4), United Kingdom (4), Sweden (2), Netherlands (1) and Poland (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Participants With Visual Acuity as Assessed by an Age-appropriate Method at 6 Months Corrected Age (CA) (time frame: At 6 Months CA). Number of Participants With Visual Acuity as Assessed by an Age-appropriate Method at 12 Months CA (time frame: At 12 Months CA). Number of Participants With Visual Acuity as Assessed by an Age-appropriate Method at 20 Months CA (time frame: At 20 Months CA).

It also tracked 22 secondary outcomes, for example Change From Baseline in Body Weight Z-score, Change From Baseline in Height Z-score, Change From Baseline in Head Circumference Z-score, Cognitive Development as Assessed by Wechsler Preschool and Primary Scale of Intelligence (WPPSI-IV) Full Scale at 5 Years CA, Number of Participants With Abnormal Physical Examination and Number of Participants Diagnosed With Neurological Examination for Cerebral Palsy (CP) by Neurological Examination at 24 Months CA.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Mecasermin (rhIGF-1) in 76 people.

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

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