Can a single eye injection save sight in premature infants?
NCT ID NCT07721298
First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time
Summary
This trial investigates whether an injection of ranibizumab, a drug that blocks abnormal blood vessel growth, can effectively treat aggressive posterior retinopathy of prematurity (AP-ROP) in premature infants. AP-ROP is a fast-progressing eye condition that can lead to retinal detachment and permanent blindness if not treated quickly. The study will measure how well the disease responds to the injection, how often it comes back, and whether additional injections are needed, with the goal of improving treatment strategies for these vulnerable babies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an anti-VEGF drug called ranibizumab, injected into the eye
- What this could lead to
- If it works, this could offer a vision-saving treatment for premature infants with a severe form of eye disease, potentially avoiding blindness.
- What could go wrong
- This is a small, early-stage trial with 39 infants, and the treatment may not work for all or could cause side effects like eye infection or disease recurrence.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
39 people
The number who actually took part.
- Started
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Sep 2021
- Finished
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Feb 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
Up to 6 weeks
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Premature infants diagnosed with aggressive posterior retinopathy of prematurity (AP-ROP) according to the International Classification of Retinopathy of Prematurity. * Gestational age ≤34 weeks or birth weight ≤2000 g. * Infants with gestational age \>34 weeks or birth weight \>2000 g were eligible if they had additional systemic risk factors, including respiratory distress syndrome, patent ductus arteriosus, sepsis, necrotizing enterocolitis, need for mechanical ventilation, or blood transfusion. * Infants whose parents or legal guardians provided written informed consent for treatment and follow-up. Exclusion Criteria: * Previous treatment for retinopathy of prematurity with intravitreal anti-VEGF therapy, laser photocoagulation, cryotherapy, or vitreoretinal surgery. * Presence of retinal disease other than retinopathy of prematurity. * Major congenital ocular anomalies that could interfere with retinal assessment or treatment response. * Known genetic syndromes or systemic conditions judged by the investigators to significantly affect retinal vascular development or study follow-up. * Media opacity or other ocular condition preventing adequate fundus examination or retinal imaging. * Inability to complete the planned follow-up schedule. * Refusal or withdrawal of consent by parents or legal guardians.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Ainshams University
Cairo, Egypt
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Other studies related to the condition(s) this trial covers.
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