- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00622726
Bevacizumab Eliminates the Angiogenic Threat for Retinopathy of Prematurity (BEAT-ROP)
May 8, 2017 updated by: Helen Mintz-Hittner, MD, The University of Texas Health Science Center, Houston
Intravitreal Bevacizumab (AvastinTM) Injections Versus Conventional Laser Surgery for Vision-threatening Retinopathy of Prematurity: a Prospective, Randomized, Non-blinded, Controlled, Multi-center, Clinical Trial
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Pasadena, California, United States, 91109
- Huntington Memorial Hospital
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Colorado
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Denver, Colorado, United States, 80218
- Presbyterian-St. Luke's Hospital
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Illinois
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Peoria, Illinois, United States, 61637
- OSF St. Francis Medical Center-Children's Hospital of Illinois
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South Carolina
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Columbia, South Carolina, United States, 29203
- Palmetto Health Richland Hospital
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Columbia, South Carolina, United States, 29223
- Palmetto Health Baptist Hospital
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Texas
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Corpus Christi, Texas, United States, 78411
- Driscoll Children's Hospital
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Dallas, Texas, United States, 75346
- Baylor University Medical Center
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El Paso, Texas, United States, 79902
- Las Palmas Medical Center
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El Paso, Texas, United States, 79905
- R.E. Thomason Hospital
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El Paso, Texas, United States, 79925
- Del Sol Medical Center
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Fort Worth, Texas, United States, 76104
- Cook Children's Medical Center
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Houston, Texas, United States, 77030
- Children's Memorial Hermann Hospital
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Houston, Texas, United States, 77002
- St. Joseph Medical Center
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Houston, Texas, United States, 77074
- Memorial Hermann Southwest Hospital
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Webster, Texas, United States, 77598
- Clear Lake Regional Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 weeks to 5 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bevacizumab for ROP
Intravitreal Bevacizumab Therapy is the Experimental Arm of this Study
|
Anti-angiogenic drug: intravitreal injection of 0.625 mg (0.025 ml) once into each eye.
Other Names:
|
Active Comparator: Conventional Laser for ROP
Conventional Laser to the Peripheral Retina is the Control Arm of this Study
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Conventional Laser is applied to the Avascular Peripheral Retina (Anterior to the Vascularized Posterior Retina)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
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). |
54 weeks postmenstrual age (window of 50 to 70 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Myopia in Zone I and Posterior Zone II of Infant Eyes
Time Frame: 2.5 years of age
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Myopia was determined via refraction using a retinoscope and lenses.
Myopia is defined as a refractive error reported in Diopters.
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2.5 years of age
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Visual Acuity
Time Frame: Age 7 years.
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The visual acuity will be measured at 20 feet with figures or letters from all infants able to cooperate.
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Age 7 years.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Helen A. Mintz-Hittner, M.D., The University of Texas Health Science Center, Houston
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Mintz-Hittner HA, Best LM. Antivascular endothelial growth factor for retinopathy of prematurity. Curr Opin Pediatr. 2009 Apr;21(2):182-7. doi: 10.1097/MOP.0b013e32832925f9.
- Mintz-Hittner HA. Avastin as monotherapy for retinopathy of prematurity. J AAPOS. 2010 Feb;14(1):2-3. doi: 10.1016/j.jaapos.2009.12.002. No abstract available.
- Mintz-Hittner HA. Intravitreal pegaptanib as adjunctive treatment for stage 3+ ROP shown to be effective in a prospective, randomized, controlled multicenter clinical trial. Eur J Ophthalmol. 2012 Sep-Oct;22(5):685-6. doi: 10.5301/ejo.5000176.
- Mintz-Hittner HA. Treatment of retinopathy of prematurity with vascular endothelial growth factor inhibitors. Early Hum Dev. 2012 Dec;88(12):937-41. doi: 10.1016/j.earlhumdev.2012.09.019. Epub 2012 Oct 15.
- Mintz-Hittner HA, Kuffel RR Jr. Intravitreal injection of bevacizumab (avastin) for treatment of stage 3 retinopathy of prematurity in zone I or posterior zone II. Retina. 2008 Jun;28(6):831-8. doi: 10.1097/IAE.0b013e318177f934. Erratum In: Retina. 2008 Oct;28(9):1374.
- Kong L, Mintz-Hittner HA, Penland RL, Kretzer FL, Chevez-Barrios P. Intravitreous bevacizumab as anti-vascular endothelial growth factor therapy for retinopathy of prematurity: a morphologic study. Arch Ophthalmol. 2008 Aug;126(8):1161-3. doi: 10.1001/archophthalmol.2008.1. No abstract available.
- Mintz-Hittner HA, Kennedy KA, Chuang AZ; BEAT-ROP Cooperative Group. Efficacy of intravitreal bevacizumab for stage 3+ retinopathy of prematurity. N Engl J Med. 2011 Feb 17;364(7):603-15. doi: 10.1056/NEJMoa1007374.
- Geloneck MM, Chuang AZ, Clark WL, Hunt MG, Norman AA, Packwood EA, Tawansy KA, Mintz-Hittner HA; BEAT-ROP Cooperative Group. Refractive outcomes following bevacizumab monotherapy compared with conventional laser treatment: a randomized clinical trial. JAMA Ophthalmol. 2014 Nov;132(11):1327-33. doi: 10.1001/jamaophthalmol.2014.2772.
- Mintz-Hittner HA, Geloneck MM, Chuang AZ. Clinical Management of Recurrent Retinopathy of Prematurity after Intravitreal Bevacizumab Monotherapy. Ophthalmology. 2016 Sep;123(9):1845-55. doi: 10.1016/j.ophtha.2016.04.028. Epub 2016 May 27.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2008
Primary Completion (Actual)
August 1, 2010
Study Completion (Anticipated)
August 1, 2020
Study Registration Dates
First Submitted
February 13, 2008
First Submitted That Met QC Criteria
February 22, 2008
First Posted (Estimate)
February 25, 2008
Study Record Updates
Last Update Posted (Actual)
June 6, 2017
Last Update Submitted That Met QC Criteria
May 8, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Eye Diseases
- Infant, Newborn, Diseases
- Pregnancy Complications
- Obstetric Labor Complications
- Obstetric Labor, Premature
- Infant, Premature, Diseases
- Retinal Diseases
- Premature Birth
- Retinopathy of Prematurity
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Bevacizumab
Other Study ID Numbers
- HSC-MS-08-0036
- IND: 101,578 (Other Identifier: Research to Prevent Blindness (NY, NY))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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