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

Contact Information

Mary Elizabeth  Hartnett

Simple Summary

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.

Inclusion Criteria

  1. Parent understands the protocol and is willing to provide consent.
  1. 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.
  2. Transfer to another hospital not covered by study-certified examiners is not anticipated within the next 4 weeks.
  3. 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
  4. No previous treatment for ROP in the study eye; no previous bevacizumab treatment in the non-study eye

Exclusion Criteria

The following exclusions apply to the study eye:

  1. Nasolacrimal duct obstruction
  2. Major ocular anomalies (e.g., cataract, coloboma)
  3. Any opacity that precludes an adequate view of the retina

If purulent ocular discharge is present in either eye, then the infant is ineligible.

Participant Reimbursement

Study injection will be provided without charge to participants