A Randomized Trial of Low-Dose Bevacizumab vs Laser for Type 1 ROP

  • STATUS
    Recruiting
  • End date
    Apr 17, 2029
  • participants needed
    212
  • sponsor
    Jaeb Center for Health Research
Updated on 17 November 2021

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.

Description

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.

Details
Condition Retinopathy of Prematurity
Treatment bevacizumab, Laser
Clinical Study IdentifierNCT04634604
SponsorJaeb Center for Health Research
Last Modified on17 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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