Bevacizumab Eliminates the Angiogenic Threat of Retinopathy of Prematurity (BEAT-ROP)
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Purpose
This study will determine whether injections into the vitreous of an anti-vascular endothelial growth factor (VEGF) will reduce the incidence of blindness by suppressing the neovascular phase of retinopathy of prematurity (ROP) compared to a control group receiving conventional laser therapy. The purpose of this study is to determine the efficacy of intravitreal bevacizumab in the treatment of ROP.
| Condition | Intervention | Phase |
|---|---|---|
|
Retinopathy of Prematurity |
Drug: Bevacizumab Procedure: Conventional Laser for ROP |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- An unfavorable outcome is defined as recurrence of neovascularization arising from the retinal vessels and requiring re-treatment (in either eye) before the infant reached 54 weeks PMA (window of 50 to 70 weeks). [ Time Frame: 54 weeks postmenstrual age (window of 50 to 70 weeks) ] [ 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: Five years of age ] [ Designated as safety issue: Yes ]
| Enrollment: | 150 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | May 2015 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Bevacizumab for ROP
Intravitreal Bevacizumab Therapy is the Experimental Arm of this Study
|
Drug: Bevacizumab
Anti-angiogenic drug: intravitreal injection of 0.625 mg (0.025 ml) once into each eye.
Other Name: Avastin; Monoclonal antibody
|
|
Active Comparator: Conventional Laser for ROP
Conventional Laser to the Peripheral Retina is the Control Arm of this Study
|
Procedure: Conventional Laser for ROP
Conventional Laser is applied to the Avascular Peripheral Retina (Anterior to the Vascularized Posterior Retina)
Other Name: Diode Laser is the laser utilized for this study
|
Detailed Description:
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 by RetCam retinal images 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). RetCam fluorescein angiograms will be taken when possible to document structural outcomes in greater detail. Any evidence of systemic toxicities will be documented by appropriate clinical and laboratory tests.
Eligibility| Ages Eligible for Study: | up to 22 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
- Informed Consent from a parent or guardian.
Exclusion Criteria:
- 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.
Contacts and Locations| United States, California | |
| Huntington Memorial Hospital | |
| Pasadena, California, United States, 91109 | |
| United States, Colorado | |
| Presbyterian-St. Luke's Hospital | |
| Denver, Colorado, United States, 80218 | |
| United States, Illinois | |
| OSF St. Francis Medical Center-Children's Hospital of Illinois | |
| Peoria, Illinois, United States, 61637 | |
| United States, South Carolina | |
| Palmetto Health Richland Hospital | |
| Columbia, South Carolina, United States, 29203 | |
| Palmetto Health Baptist Hospital | |
| Columbia, South Carolina, United States, 29223 | |
| United States, Texas | |
| Driscoll Children's Hospital | |
| Corpus Christi, Texas, United States, 78411 | |
| Baylor University Medical Center | |
| Dallas, Texas, United States, 75346 | |
| R.E. Thomason Hospital | |
| El Paso, Texas, United States, 79905 | |
| Del Sol Medical Center | |
| El Paso, Texas, United States, 79925 | |
| Las Palmas Medical Center | |
| El Paso, Texas, United States, 79902 | |
| Cook Children's Medical Center | |
| Fort Worth, Texas, United States, 76104 | |
| Memorial Hermann Southwest Hospital | |
| Houston, Texas, United States, 77074 | |
| Children's Memorial Hermann Hospital | |
| Houston, Texas, United States, 77030 | |
| St. Joseph Medical Center | |
| Houston, Texas, United States, 77002 | |
| Clear Lake Regional Medical Center | |
| Webster, Texas, United States, 77598 | |
| Principal Investigator: | Helen A. Mintz-Hittner, M.D. | The University of Texas Health Science Center, Houston |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Helen A. Mintz-Hittner, M.D., University of Texas Health Science Center-Houston |
| ClinicalTrials.gov Identifier: | NCT00622726 History of Changes |
| Other Study ID Numbers: | HSC-MS-08-0036, IND: 101,578 |
| Study First Received: | February 13, 2008 |
| Last Updated: | December 24, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by The University of Texas Health Science Center, Houston:
|
Vascular Endothelial Growth Factor Angiogenesis Inhibitor Premature infants Bevacizumab |
Zone I or Posterior Zone II ROP Aggressive Posterior ROP Stage 3 ROP |
Additional relevant MeSH terms:
|
Retinal Diseases Retinopathy of Prematurity Eye Diseases Infant, Premature, Diseases Infant, Newborn, Diseases Antibodies, Monoclonal Angiogenesis Inhibitors Bevacizumab |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013