Bevacizumab Eliminates the Angiogenic Threat for Retinopathy of Prematurity
- Conditions
- Retinopathy of Prematurity
- Interventions
- Procedure: Conventional Laser for ROP
- Registration Number
- NCT00622726
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
- 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.
- Informed Consent from a parent or guardian.
- Infants who have a congenital systemic anomaly or have a congenital ocular abnormality.
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional Laser for ROP Conventional Laser for ROP Conventional Laser to the Peripheral Retina is the Control Arm of this Study Bevacizumab for ROP Bevacizumab Intravitreal Bevacizumab Therapy is the Experimental Arm of this Study
- Primary Outcome Measures
Name Time Method Number of Eyes Showing Recurrence of Neovascularization Arising From the Retinal Vessels and Requiring Re-treatment 54 weeks postmenstrual age (window of 50 to 70 weeks) 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).
- Secondary Outcome Measures
Name Time Method Myopia in Zone I and Posterior Zone II of Infant Eyes 2.5 years of age Myopia was determined via refraction using a retinoscope and lenses. Myopia is defined as a refractive error reported in Diopters.
Visual Acuity Age 7 years. The visual acuity will be measured at 20 feet with figures or letters from all infants able to cooperate.
Trial Locations
- Locations (15)
Huntington Memorial Hospital
🇺🇸Pasadena, California, United States
OSF St. Francis Medical Center-Children's Hospital of Illinois
🇺🇸Peoria, Illinois, United States
R.E. Thomason Hospital
🇺🇸El Paso, Texas, United States
Las Palmas Medical Center
🇺🇸El Paso, Texas, United States
Del Sol Medical Center
🇺🇸El Paso, Texas, United States
Cook Children's Medical Center
🇺🇸Fort Worth, Texas, United States
Presbyterian-St. Luke's Hospital
🇺🇸Denver, Colorado, United States
Palmetto Health Richland Hospital
🇺🇸Columbia, South Carolina, United States
Memorial Hermann Southwest Hospital
🇺🇸Houston, Texas, United States
Palmetto Health Baptist Hospital
🇺🇸Columbia, South Carolina, United States
Driscoll Children's Hospital
🇺🇸Corpus Christi, Texas, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
St. Joseph Medical Center
🇺🇸Houston, Texas, United States
Children's Memorial Hermann Hospital
🇺🇸Houston, Texas, United States
Clear Lake Regional Medical Center
🇺🇸Webster, Texas, United States