Open Actively Recruiting

Bevacizumab Treatment For Posterior Zone I ROP

About

Brief 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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 2

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
N/A
Maximum Age
6 Months

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

Join this Trial

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Study Stats
Protocol No.
21-000919
Category
Ophthalmology
Contact
Monica Vaughn
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04634578
For detailed technical eligibility, visit ClinicalTrials.gov.