|Principal Investigator: Mary Elizabeth Hartnett|
|Keywords: Prematurity , Eye diseases , Treatments for ROP||Department: Ophthalmology-Research|
|IRB Number: 00080313||Co Investigator: Bradley Yoder|
|Specialty: Ophthalmology, Pediatric, Ophthalmology|
|Sub Specialties: Retinal Diseases|
|Recruitment Status: Completed|
Mary Elizabeth Hartnett
Determine the lowest effective dose of the intravitreally administered, anti-VEGF drug, bevacizumab (Avastin), for the treatment of Retinopathy of Prematurity (ROP). Treatment success is defined in the protocol as improvement, by day 4 following bevacizumab injection, and no recurrence of type 1 ROP/severe neovascularization.
- Parent understands the protocol and is willing to provide consent.
- If hospital discharge is anticipated within the next 4 weeks, parents are able and willing to return to the PEDIG site for outpatient follow-up visits.
- Transfer to another hospital not covered by study-certified examiners is not anticipated within the next 4 weeks.
- Type 1 ROP; defined as:
- Zone I, any stage ROP with plus disease, or
- Zone I, stage 3 ROP without plus disease, or
- Zone II, stage 2 or 3 ROP with plus disease
- No previous treatment for ROP in the study eye; no previous bevacizumab treatment in the non-study eye
The following exclusions apply to the study eye:
- Nasolacrimal duct obstruction
- Major ocular anomalies (e.g., cataract, coloboma)
- Any opacity that precludes an adequate view of the retina
If purulent ocular discharge is present in either eye, then the infant is ineligible.
Study injection will be provided without charge to participants