Can a single eye injection save sight in premature infants?

NCT ID NCT07721298

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Sep 2021

Finished

Feb 2025

Lead sponsor

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

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Retinopathy of prematurity (ROP) are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.