• Success: Retinopathy of Prematurity (Zone I or Posterior II (Stage 3) has not recurred following treatment: Intravitreal Bevacizumab versus Laser Therapy [ Time Frame: 54 weeks adjusted age (6 to 7.5 months of age) ] [ Designated as safety issue: No ]
  

• Determination of visual acuity, visual field, refraction, motility examination or any other ocular parameter related to severe ROP [ Time Frame: 80 weeks adjusted age (12 to 13.5 months of age) ] [ Designated as safety issue: No ]
  

This phase 2 study will assess the anti-neovascularization activity of intravitreal bevacizumab, as determined by regression of neovascular vessels of retinopathy of prematurity (ROP), in neonates with acute stage 3 ROP in zone I or posterior zone II with plus disease. This study will enroll confirmed cases of vision threatening ROP (between ETROP and CRYO-ROP) which have definite plus disease. This will be done because of the controversy regarding determining plus disease and the increasing concern that many infants are being treated whose ROP would spontaneously regress. Bevacizumab will be administered intravitreally using 0.625 mg (0.025 ml) injections into each eye. There is no intent to give additional doses unless there is a recurrence of vision threatening stage 3 ROP with plus disease since the disease is self limited by completion of vascularization. Clinical response and any evidence of ocular toxicities will be documented both pre- and post-injection by RetCam retinal images (structural documentation) and at 6 and 12 months of age by electroretinograms (functional documentation). Any evidence of systemic toxicities will be documented by appropriate clinical and laboratory tests.

Inclusion Criteria:

1. Infants who have been screened by the AAO, AAP, and the AAPOS guidelines (≤1500 grams at birth and ≤30 weeks gestation) who develop Stage 3 ROP in zone I or posterior zone II.
2. Informed Consent from a parent or guardian.

Exclusion Criteria:

1. Infants who have a congenital systemic anomaly or have a congenital ocular abnormality.
2. Infants who cannot be treated by conventional laser therapy because of problems with media clarity. Generally, blind external cryotherapy would be utilized as an initial therapy and the infant would be excluded from the study even if the media clear subsequently.
3. Informed Consent from a parent or guardian refused. This will mean that an infant automatically will receive laser therapy. Bevacizumab (Avastin®) treatment cannot be given outside of the Protocol. No data will be used from an infant without Informed Consent.