Active — Not RecruitingPhase 2

Bevacizumab Treatment For Type 1 ROP

United States77 participantsStarted 2022-05-01

Plain-language summary

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.

Who can participate

Age range6 Months

SexALL

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Inclusion criteria

✓. Birth weight \< 1251 grams
✓. Newly diagnosed (within 2 days) type 1 ROP in zone I in one or both eyes

Exclusion criteria

✕. Previous treatment for ROP
✕. Stage 4 or 5 ROP in either eye
✕. Treatment could not be done within 2 days of diagnosis of type 1 ROP
✕. Investigator unwilling to randomize or parent unwilling to accept randomized assignment to either treatment
✕. 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.
✕. Active ocular infection or purulent nasolacrimal duct obstruction in either eye

What they're measuring

Treatment Success at 4 Weeks Post Injection

Timeframe: 4 weeks

Trial details

NCT IDNCT04634578

SponsorJaeb Center for Health Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-01

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