Summary

Eligibility
for people ages up to 6 months (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

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.

Official Title

Bevacizumab Treatment For Posterior Zone I Retinopathy of Prematurity

Details

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.

Keywords

Retinopathy of Prematurity Retinal Diseases Premature Birth Bevacizumab Bevacizumab- 0.063 mg Bevacizumab- 0.25 mg

Eligibility

You can join if…

Open to people ages up to 6 months

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

  1. Birth weight < 1251 grams
  2. 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
  3. 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.

You CAN'T join if...

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

  1. Previous treatment for ROP
  2. Stage 4 or 5 ROP in either eye
  3. Treatment could not be done within 2 days of diagnosis of type 1 ROP
  4. Investigator unwilling to randomize or parent unwilling to accept randomized assignment to either treatment
  5. 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.
  6. 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

Locations

  • University of California San Francisco Department of Ophthalmology accepting new patients
    San Francisco California 94143 United States
  • University of California, Davis accepting new patients
    Sacramento California 95817 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Jaeb Center for Health Research
Links
PEDIG Public Website
ID
NCT04634578
Phase
Phase 2
Study Type
Interventional
Last Updated