Bevacizumab Eliminates the Angiogenic Threat for Retinopathy of Prematurity

The University of Texas Health Science Center, Houston150 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Retinopathy of Prematurity

Interventions

BevacizumabDRUG

Anti-angiogenic drug: intravitreal injection of 0.625 mg (0.025 ml) once into each eye.

Conventional Laser for ROPPROCEDURE

Conventional Laser is applied to the Avascular Peripheral Retina (Anterior to the Vascularized Posterior Retina)

Eligibility

Sex: ALLMin age: 4 WeeksMax age: 22 Weeks

Medical Language ↔ Plain English

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.

Locations (15)

Huntington Memorial Hospital

Pasadena, California, United States

Presbyterian-St. Luke's Hospital

Denver, Colorado, United States

Outcomes

Primary Outcomes

Number of Eyes Showing Recurrence of Neovascularization Arising From the Retinal Vessels and Requiring Re-treatment

For Bevacizumab: Regrowth of new vessels at the site of the original extraretinal fibrovascular proliferation and/or at the site of the anterior edge of inner retinal vascularization. For Laser: Regrowth of new vessels from the vessels at the anterior edge of inner retinal vascularization (remaining after retinal ablation).

Time frame: 54 weeks postmenstrual age (window of 50 to 70 weeks)

Secondary Outcomes

Myopia in Zone I and Posterior Zone II of Infant Eyes

Myopia was determined via refraction using a retinoscope and lenses. Myopia is defined as a refractive error reported in Diopters.

Time frame: 2.5 years of age

Visual Acuity

The visual acuity will be measured at 20 feet with figures or letters from all infants able to cooperate.

Time frame: Age 7 years.

Data from ClinicalTrials.gov

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