Title

Bevacizumab Treatment For Posterior Zone I ROP
Bevacizumab Treatment For Posterior Zone I Retinopathy of Prematurity
  • Phase

    Phase 2
  • Study Type

    Interventional
  • Status

    Recruiting
  • Study Participants

    80
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.
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.
Study Started
May 18
2022
Primary Completion
Dec 31
2023
Anticipated
Study Completion
Jun 30
2024
Anticipated
Last Update
Jul 21
2022

Drug Bevacizumab

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

Bevacizumab- 0.063 mg Experimental

Participants will receive a single intravitreal injection of 0.063 mg 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.

Bevacizumab- 0.25 mg Experimental

Participants will receive a single intravitreal injection of 0.25 mg 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.

Criteria

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 (as defined in section 2.4.2), with ROP and retinal vessels all in zone I, in one or both eyes
Parent understands the protocol and is willing to provide consent.

If both eyes are eligible, then both are included. If one eye is eligible and the other eye has type 1 ROP with ROP or vessels in zone 2, then both eyes will receive the treatment randomly assigned. If one eye is eligible and the fellow eye later develops type 1 ROP within 4 weeks of injection in the first eye, then the fellow eye will also receive the treatment randomly assigned to the first eye and the fellow eye will follow the same 4-week post-injection study exam schedule, unless the first eye has already met failure criteria, in which case treatment and follow-up for the fellow eye is at investigator discretion.

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
No Results Posted