for people ages up to 6 months (full criteria)
at Irvine, California and other locations
study started
estimated completion



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


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.


Retinopathy of Prematurity, Retinal Diseases, Premature Birth, Bevacizumab, Laser


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


  • Univ of California, Irvine- Gavin Herbert Eye Institute accepting new patients
    Irvine California 92697 United States
  • Arizonia Pediatric Eye Specialists not yet accepting patients
    Phoenix Arizona 85006 United States


accepting new patients
Start Date
Completion Date
Jaeb Center for Health Research
PEDIG Public Website
Phase 3 research study
Study Type
Expecting 212 study participants
Last Updated