TerminatedPhase 3

A Randomized Trial of Low-Dose Bevacizumab vs Laser for Type 1 ROP

Stopped: Lack of feasibility to recruit.

United States, Canada16 participantsStarted 2022-04-27

Plain-language summary

This randomized clinical trial will compare retinal outcomes with low-dose intravitreous bevacizumab (0.063 mg) versus laser photocoagulation as treatment for infants with type 1 retinopathy of prematurity (ROP). The study also will assess neurodevelopment, refractive error, visual acuity, and peripheral visual fields.

Who can participate

Age range

6 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Birth weight \< 1251 grams * Newly diagnosed (within 2 days) type 1 ROP in one or both eyes; meeting the following criteria: * Zone I, any stage ROP with plus disease, with retinal vessels or ROP in Zone II in any quadrant, or * Zone I, stage 3 ROP without plus disease, with retinal vessels or ROP in zone II in any quadrant or * Zone II, stage 2 or 3 ROP with plus disease Exclusion Criteria: * Previous treatment for ROP * Stage 4 or 5 ROP in either eye * All ROP in zone I in either eye (no retinal vessels or ROP extend into zone II in any quadrant) * Either treatment could not be done within 2 days of diagnosis of type 1 ROP * Investigator unwilling to randomize or parent unwilling to accept random assignment to either treatment * Transfer to another hospital not covered by study-certified examiners anticipated within the next 4 weeks * Active ocular infection or purulent nasolacrimal duct obstruction in either eye One eye will be excluded, and other eye may be eligible, if either of the following are present: * Visually significant ocular anomaly (e.g., cataract, coloboma) * Opacity that precludes an adequate view of the retina

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Treatment Success Rate At 6 Months Adjusted Age

Timeframe: 6 Months Adjusted Age

Trial details

NCT IDNCT04634604

SponsorJaeb Center for Health Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-14

Results submitted2024-06-24

View on ClinicalTrials.gov More Retinopathy of Prematurity trials