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

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.

Official Title

A Randomized Trial of Low-Dose Bevacizumab Versus Laser for Type 1 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 peripheral retinal laser ablation. Study exams will be at weeks 1, 2, 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 months, 1 year, and then annually for 5 more years. Non-study examinations will be at clinician discretion and are likely to occur more often. The primary outcome will be treatment success, defined as no worsening of ROP 5-13 days after treatment (or re-treatment if indicated), no plus disease or severe neovascularization 2 weeks to 6 months after treatment (or re-treatment if indicated), and no unfavorable structural outcome (or prior scleral buckle or vitrectomy) at 6 months adjusted age. Important secondary outcomes include the number of re-treatments, extent of retinal vascularization, refractive error, neurodevelopment assessed by the Bayley-4 test, IQ and neuropsychiatric testing, visual acuity, visual fields, and systemic morbidities.

Keywords

Retinopathy of Prematurity Retinal Diseases Premature Birth Bevacizumab Laser

Eligibility

You can join if…

Open to people ages up to 6 months

  • 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

You CAN'T join if...

  • 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

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
NCT04634604
Phase
Phase 3
Study Type
Interventional
Last Updated