Bevacizumab Treatment For Type 1 ROP

Type 1 retinopathy of prematurity in zone I represents the most severe type of ROP and has the worst prognosis. It is unknown whether low-dose bevacizumab will be successful in these severe cases. Also unknown is the timing and extent of peripheral retinal vascularization after low-dose bevacizumab compared with the standard dose. The current study will evaluate whether doses of 0.063 mg and 0.25mg are effective as treatment for type 1 ROP, with ROP and retinal vessels all in zone I.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Retinopathy of Prematurity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Infant, Newborn, Diseases Infant, Premature, Diseases Retinal Diseases

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

IWK Health Centre, Halifax, Nova Scotia, Canada

About this study

Infants with type 1 ROP and no prior treatment for ROP will be randomly assigned (1:1) to treatment with either intravitreous bevacizumab 0.063 mg or either intravitreous bevacizumab 0.25 mg. Study exams will be at 1 day, 4 days (if no improvement on day 1), 1, 2, 3, and 4 weeks, and at 2 and 4-months post-treatment (and re-treatment when indicated). Additional study exams will occur at adjusted age 6 and 12 months. Non-study examinations will be at clinician discretion and are likely to occur more often. The primary outcome will be treatment success within each dose group, defined as improvement by the day 4 exam and no recurrence of type 1 ROP or severe neovascularization requiring additional treatment within 4 weeks of injection. Important secondary outcomes include safety and efficacy. refractive outcomes, and the extent of retinal vascularization at 2 and 4 months post-injection between the two dose groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The study participant must have at least one eye meeting all of the inclusion criteria in order to be eligible to participate:

Birth weight < 1251 grams
Newly diagnosed (within 2 days) type 1 ROP in zone I in one or both eyes

Exclusion criteria

Participants meeting any of the following exclusion criteria will be excluded from study participation.

Previous treatment for ROP
Stage 4 or 5 ROP in either eye
Treatment could not be done within 2 days of diagnosis of type 1 ROP
Investigator unwilling to randomize or parent unwilling to accept randomized assignment to either treatment
Transfer to another hospital anticipated within the next 4 weeks where exams by study-certified examiners are not available. If hospital discharge is anticipated within the next 4 weeks, parents unable or unwilling to return to the PEDIG site for outpatient follow-up visits.
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

Treatment and study plan

Bevacizumab

Drug

All participants will receive a single intravitreal injection of bevacizumab in one or both eyes following enrollment into the study. The injection/s should be given as soon as possible but no later than 2 days after the diagnosis of type 1 ROP meeting all of the inclusion criteria and none of the exclusion criteria.

Eyes meeting eligibility criteria will receive a single dose of 0.063 mg or 0.25mg bevacizumab provided by the pharmacy at the investigator's institution.

Other names: Avastin

Primary outcomes

Treatment Success at 4 Weeks Post Injection

Time frame: 4 weeks
Treatment success, determined at 4 weeks, post injection, and meeting all the following criteria:
- Improvement by the 4-day exam (3 to 5 days)
- No recurrence of type 1 ROP or severe neovascularization requiring additional treatment within 4 weeks of injection.

Sponsors and collaborators

Lead sponsor

Jaeb Center for Health Research

Other

Collaborators

National Eye Institute (NEI)
Pediatric Eye Disease Investigator Group

Registry information

Official study title

Bevacizumab Treatment For Type 1 Retinopathy of Prematurity

Acronym: ROP4

Important dates

Study start: 2022
Primary completion: 2025
Study completion: 2027
First posted: Nov 18, 2020
Registry last updated: Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting