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
Conditions:	Ocular, Ocular, Women's Studies
Therapuetic Areas:	Ophthalmology, Reproductive
Healthy:	No
Age Range:	Any
Updated:	3/29/2019
Start Date:	March 26, 2015
End Date:	August 13, 2021

Long-term Outcome of Children Enrolled in Study ROPP-2008-01 Previously Treated With rhIGF-1/rhIGFBP-3 for the Prevention of Retinopathy of Prematurity (ROP) or Who Received Standard Neonatal Care

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).

Inclusion Criteria:

1. Participant was randomized in Study ROPP-2008-01, Section D

2. 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:

1. 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

2. The participant or participants parent or legally authorized representative(s) is
unable to comply with the protocol as determined by the Investigator

We found this trial at

sites

Azienda Ospedaliera Universitaria Careggi

Firenze, 50134

from

Firenze,