ROP4

About this trial

Last updated 3 years ago

Study ID

ROP4

Status

Recruiting

Type

Interventional

Phase

Phase 2

Placebo

Accepting

Up to 6 Years

All

Not accepting

Healthy Volunteers

Trial Timing

Ended a year ago

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.

Inclusion Criteria

1. Birth weight < 1251 grams

2. Newly diagnosed (within 2 days) type 1 ROP in zone I in one or both eyes

Exclusion Criteria

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