This trial is active, not recruiting.

Condition retinopathy of prematurity
Treatments bevacizumab, conventional laser for rop
Phase phase 2
Target VEGF
Sponsor The University of Texas Health Science Center, Houston
Start date March 2008
End date October 2010
Trial size 150 participants
Trial identifier NCT00622726, HSC-MS-08-0036, IND: 101,578


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Intravitreal Bevacizumab Therapy is the Experimental Arm of this Study
bevacizumab Avastin; Monoclonal antibody
Anti-angiogenic drug: intravitreal injection of 0.625 mg (0.025 ml) once into each eye.
(Active Comparator)
Conventional Laser to the Peripheral Retina is the Control Arm of this Study
conventional laser for rop Diode Laser is the laser utilized for this study
Conventional Laser is applied to the Avascular Peripheral Retina (Anterior to the Vascularized Posterior Retina)

Primary Outcomes

Number of Eyes Showing Recurrence of Neovascularization Arising From the Retinal Vessels and Requiring Re-treatment
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
time frame: 2.5 years of age
Visual Acuity
time frame: Age 7 years.

Eligibility Criteria

Male or female participants up to 22 weeks old.

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.

Additional Information

Official title Intravitreal Bevacizumab (AvastinTM) Injections Versus Conventional Laser Surgery for Vision-threatening Retinopathy of Prematurity: a Prospective, Randomized, Non-blinded, Controlled, Multi-center, Clinical Trial
Principal investigator Helen A. Mintz-Hittner, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston.