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Can a lower dose of an eye drug protect preterm Infants' sight?

NCT ID NCT06717412

Disease control Sponsor: Wang Yusheng Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This trial investigates whether a low dose of the drug conbercept can effectively treat retinopathy of prematurity (ROP), an eye disease that can cause blindness in preterm infants. The study will enroll 146 preterm babies with type 1 ROP and compare the low-dose treatment against standard care. The goal is to find a dose that stops the disease while minimizing risks.

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 conbercept, injected into the eye
What this could lead to
If successful, this could establish a safer, effective dose of conbercept to treat retinopathy of prematurity, potentially reducing side effects in vulnerable infants.
What could go wrong
This is a relatively small trial, and the lower dose may not work as well as the standard dose. There are also risks from the injection itself, such as infection or eye damage.

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

About 146 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Jan 2028

An estimate. End dates often move.

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Preterm infants with less than or equal to 2000 grams of birth weight or less than or equal to 32 weeks of gestational age * Bilateral type 1 ROP with one of the following retinal findings in each eye * Zone I, stage 1+, 2+, 3+/- disease, or * Zone II, stage 2+, 3+, disease, or * A-ROP Exclusion Criteria: * Preterm infants with stage 4 or 5 ROP in one or both eyes * Have received any previous surgical or nonsurgical treatment for ROP, including laser photocoagulation, anti-VEGF therapy, vitrectomy * Have been previously exposed to any intravitreal or systemic anti-VEGF agent (either the patient or the mother during this child's pregnancy) * Have used (either the patient or the mother) other investigational drugs as part of another clinical study (other than vitamins and minerals) within 30 days or within 5 half-lives of the other investigational drug, whichever is longer * Have active ocular infection within 5 days before or on the day of first investigational treatment * Have a history of hypersensitivity (either the patient or the mother) to any of the investigational treatments or to drugs of similar chemical classes * Have any contraindication for intravitreal injection clearly stated in the instructions * Have any ocular structural abnormality that may affect efficacy assessments * Have a history of any other congenital or systemic conditions that are assessed by the investigator to have a significant risk of severe impact on visual function * Have any other medical conditions or clinically significant comorbidities or personal circumstances that are assessed by the investigator to have a clinically relevant impact on study participation, any of the study procedures, or on efficacy assessments

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Conditions

The condition(s) this trial relates to.

retinopathy of prematurity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Retinopathy of prematurity (ROP)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Ophthalmology, Xianyang Rainbow Hospital

    RECRUITING

    Xianyang, Shaanxi, 712000, China

  • Department of Ophthalmology, Xijing Hospital, Air Force Military Medical University

    RECRUITING

    Xi'an, Shaanxi, 710032, China

  • Department of Ophthalmology, the Second Affiliated Hospital of Xi'an Medical University

    RECRUITING

    Xi'an, Shaanxi, 710032, China

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