Bevacizumab Treatment For Posterior Zone I ROP (ROP4)

K
Kathryn Haider, MD

Primary Investigator

Enrolling By Invitation
6 years and younger
All
Phase 2
80 participants needed
1 Location

Brief description of study

Type 1 retinopathy of prematurity in zone I represents the most severe type of ROP and hashe worst prognosis. It is unknown whether low-dose bevacizumab will be successful in thesevere cases. Also unknown is the timing and extent of peripheral retinal vascularizationw-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 andvessels all in zone I.

Detailed description of study

Infants with type 1 ROP and no prior treatment for ROP will be randomly assigned (1:1) towith either intravitreous bevacizumab 0.063 mg or either intravitreous bevacizumab.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). Additionaludy exams will occur at adjusted age 6 and 12 months. Non-study examinations will be atdiscretion and are likely to occur more often. The primary outcome will beuccess within each dose group, defined as improvement by the day 4 exam and nourrence of type 1 ROP or severe neovascularization requiring additional treatment within 4 weeks of injection. Important secondary outcomes include safety and efficacy. refractiveutcomes, and the extent of retinal vascularization at 2 and 4 months post-injection betweenhe two dose groups.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Retinopathy of Prematurity, Riley
  • Age: - 6 Months
  • Gender: All

Inclusion Criteria: 
The study participant must have at least one eye meeting all of the inclusion criteria in order to be eligible to participate:
Exclusion Criteria:
Participants meeting any of the following exclusion criteria will be excluded from study participation.
One eye will be excluded, and other eye may be eligible, if either of the following are present:

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 in zone I in one or both eyes
Exclusion Criteria:
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

Updated on 13 Sep 2024. Study ID: ROP4, OPTH-JAEB-ROP4, 12612
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