Bevacizumab Eliminates the Angiogenic Threat for Retinopathy of Prematurity (BEAT-ROP)

The University of Texas System (UT)

Status and phase: Unknown; Phase 2

Conditions: Retinopathy of Prematurity

Treatments: Procedure: Conventional Laser for ROP; Drug: Bevacizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT00622726

HSC-MS-08-0036

IND: 101,578 (Other Identifier)

Details and patient eligibility

About

The purpose of this study was to determine the efficacy and additional advantages of intravitreal bevacizumab in the treatment of ROP for both Zone I and Zone II Posterior.

Full description

This phase 2 study assessed 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 enrolled 150 confirmed cases of vision threatening ROP which have definite plus disease [ranging from Early Treatment for Retinopathy of Prematurity, to Cryotherapy for Retinopathy of Prematurity . This was 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 was no intent to give additional doses unless there was 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 were documented by retinal imaging system (manufactured by Clarity Medical Systems, Inc.) taken pre-injection, one week and one month post injection, and at 6 months of age (54 weeks postmenstrual age)(window of 50 to 70 weeks PMA)(primary outcome) and at 12 months of age (80 weeks postmenstrual age)(window of 75 to 100 weeks PMA)(structural documentation). Using the same retinal imaging system, fluorescein angiograms have been taken when possible to document structural outcomes in greater detail. No evidence of systemic toxicities were documented by appropriate clinical and laboratory tests.

Enrollment: 150 patients

Sex: All

Ages: 4 to 22 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Infants who have been screened by the American Academy of Ophthalmology, the American Academy of Pediatrics, and the American Association for Pediatric Ophthalmology and Strabismus 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Bevacizumab for ROP

Experimental group

Description:

Intravitreal Bevacizumab Therapy is the Experimental Arm of this Study

Treatment:

Drug: Bevacizumab

Conventional Laser for ROP

Active Comparator group

Description:

Conventional Laser to the Peripheral Retina is the Control Arm of this Study

Treatment:

Procedure: Conventional Laser for ROP