Pan-VEGF Blockade for the Treatment of Retinopathy of Prematurity (BLOCK-ROP)
NCT ID: NCT01232777
Last Updated: 2013-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2012-06-30
2018-07-31
Brief Summary
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Detailed Description
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The retina lines the inside of the eye. It functions as "film" within the camera, which is the eye. When an infant is born prematurely, the vascular network necessary to nourish the retina has not fully developed. As a consequence, in some infants abnormal vessels grow instead of the normal ones--a condition known as ROP. The abnormal vessels carry scar tissue along with them, and may lead to retinal detachment and blindness if the eye is not treated.
The multi-center trial of Cryotherapy for Retinopathy of Prematurity (CRYo-ROP) Study demonstrated that ablation of the peripheral avascular retina reduced the risk of poor structural and visual outcome due to retinal distortion or detachment in ROP (1980's). The ablated retina is not functional and is not amendable to regeneration.
Peripheral retinal ablation is not universally effective in fostering regression of ROP. This is particularly true for an aggressive form of ROP (aggressive posterior ROP, or APROP), which typically afflicts profoundly premature and sick neonates. In this subset of infants, progression of ROP to retinal detachments in both eyes and even blindness may occur despite timely and complete peripheral retinal laser ablation.
RATIONALE:
The development of ROP is largely dependant on vascular endothelial growth factor (VEGF). When an infant is born prematurely, the relatively hyperoxic environment that the baby is introduced to shuts down the production of VEGF. Retinal maturation is thus delayed. Subsequently, at a time when intraocular VEGF levels would be declining late in the third trimester of pregnancy, abnormally high levels of VEGF are seen due to large areas of avascular retina and associated tissue hypoxia.
The availability of FDA-approved drugs for anti-VEGF treatment renders it possible to treat such eye off-label. Available drugs include pegaptanib sodium (Macugen) for partial blockage of VEGF-A, or drugs such a ranibizumab (Lucentis) and bevacizumab (Avastin), which cause complete blockage of VEGF-A.
As VEGF is required in the developing retina for normal angiogenesis, and our goal is not to penetrate tissue, but to block the excessive levels of VEGF trapped within the overlying vitreous which is responsible for the abnormal vasculature in ROP.
For purposes of this study, we have chosen bevacizumab (Avastin) which will: a) attain complete blockage (vs. Macugen) of intravitreal VEGF-A, and b)which is limited in its ability to penetrate tissues because it is a full antibody (vs. Lucentis, an antibody fragment specifically designed for better tissue penetration), and is more likely to restore VEGF homeostasis within the developing retina.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Bevacizumab (Avastin) 0.75mg/0.03cc
1/3 of study participants will be randomized to this treatment in one eye (study eye) and the other eye will receive laser (fellow eye)
Bevacizumab
A single dosage of: 0.625mg(0.025cc)or 0.75mg(0.03cc) will be given intravitreally.
Bevacizumab (Avastin) 0.625mg/0.025cc
1/3 of patients will be randomized to this treatment in 1 eye (study eye) and the other eye will receive laser (fellow eye).
Bevacizumab
A single dosage of: 0.625mg(0.025cc)or 0.75mg(0.03cc) will be given intravitreally.
Laser ablation
1/3 of study participants will be randomized to this treatment in both eyes (study eye and fellow eye)
Bevacizumab
A single dosage of: 0.625mg(0.025cc)or 0.75mg(0.03cc) will be given intravitreally.
Interventions
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Bevacizumab
A single dosage of: 0.625mg(0.025cc)or 0.75mg(0.03cc) will be given intravitreally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No prior treatment
* Post menstrual age less than 36 1/7 weeks
* Post menstrual age greater than 30 weeks
Exclusion Criteria
* An ocular anomaly of one or both eye affecting the retina or choroid
* An ocular anomaly precluding use of the RetCam (ex., microphthalmia)
* Neonatologist feels inclusion will unduly challenge the infant
* Refusal of initial consent
* Refusal of subsequent evaluation
* Media opacity precluding fundus visualization (ex., cataract)
* Any ocular or periocular infection(s)
30 Weeks
36 Weeks
ALL
No
Sponsors
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Vision Research Foundation
OTHER
Responsible Party
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Michael T. Trese, M.D.
VitreoRetinal Surgeon & Researcher
Principal Investigators
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Michael T Trese, MD
Role: PRINCIPAL_INVESTIGATOR
Vision Research Foundation
Locations
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Children's Hospital Los Angeles
Los Angeles, California, United States
Jules Stein Eye Institute, UCLA
Los Angeles, California, United States
Eye Insitute at Stanford
Palo Alto, California, United States
Bascon Palmer Eye Institute
Miami, Florida, United States
Emory Eye Center
Atlanta, Georgia, United States
Children's Hospital, Dept. of Ophthalmology
Boston, Massachusetts, United States
Associated Retinal Consultants/William Beaumont Hospital
Royal Oak, Michigan, United States
Insitute of Ophthalmology and Medical Science, New Jersey Medical School
Newark, New Jersey, United States
Department of Ophthalmology, Weill Cornell Medical College
New York, New York, United States
Abrahamson Pediatric Eye Institute, Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Midwest Retina
Dublin, Ohio, United States
University Hospitals Eye Insitute, Rainbow Babies & Children's Hospital
Mayfield Heights, Ohio, United States
St. Christopher's Hospital for Children, Drexel Univ. School of Medicine
Philadelphia, Pennsylvania, United States
Austin Retina Associates
Austin, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
University of Utah, Moran Eye Center
Salt Lake City, Utah, United States
Medical College of Wisconsin--Eye Insititute
Milwaukee, Wisconsin, United States
Ells Retina Centre
Calgary, Alberta, Canada
Countries
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Other Identifiers
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002
Identifier Type: -
Identifier Source: org_study_id