Study Stopped
Low enrollment due to the stringent enrollment criteria. Unable to answer study questions
Pan-VEGF Blockade for the Treatment of Retinopathy of Prematurity
BLOCK-ROP
Phase 1 Trial of Pan-VEGF Blockade for the Treatment of Retinopathy of Prematurity
1 other identifier
interventional
2
2 countries
11
Brief Summary
Retinopathy of Prematurity (ROP) is a leading cause of blindness in children in developed countries around the world, and an increasing cause of blindness in developing countries. 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 proliferate 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 Multicenter 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 amenable 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 infirm neonates. In this subset of infants, progression of ROP to bilateral retinal detachment and blindness occurs despite timely and complete peripheral retinal laser ablation. Rationale The development of ROP is largely dependent on vascular endothelial growth factor (VEGF). When an infant is born prematurely the relatively hyperoxic environment the baby is introduced to shuts down the production of VEGF. Retinal maturation is delayed. Subsequently, at a time when intraocular VEGF levels would normally 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 eyes off-label. Available drugs include pegaptanib sodium (Macugen) for partial blockage of VEGF-A, or drugs such as 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 the investigators 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2008
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 19, 2008
CompletedFirst Posted
Study publicly available on registry
June 20, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedJanuary 27, 2010
June 1, 2008
1 year
June 19, 2008
January 26, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary aim is to evaluate the safety of Bevacizumab (Avastin) administered in a single dose into the vitreous cavity.
Weekly
Secondary Outcomes (1)
The secondary therapeutic study aim is to determine the efficacy of treatment with Bevacizumab (Avastin) for improving structural outcome without surgical intervention.
Weekly
Interventions
Eligibility Criteria
You may qualify if:
- Aggressive posterior ROP
- Adequate/appropriate laser ablation
- Failed standard laser treatment (persistent Plus or recurrent Plus at a minimum of 1 week post-laser)
- Post-menstrual age less than 36 weeks
- Post-menstrual age greater than 30 weeks
You may not qualify if:
- Fatal systemic anomaly
- An ocular anomaly of one or both eyes affecting the retina or choroid
- An ocular anomaly precluding use of the RetCam (eg: microphthalmia)
- Refusal of initial consent
- Refusal of subsequent evaluation
- Media opacity precluding fundus visualization (eg: cataract)
- Any ocular or periocular infection(s)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Childrens Hospital
Los Angeles, California, 90027, United States
Jules Stein Eye Center
Los Angeles, California, 90095, United States
California Vitreoretinal Center
Menlo Park, California, 94025, United States
Bascom Palmer Eye Institute
Miami, Florida, 33136, United States
Emory Eye Center
Atlanta, Georgia, 30322, United States
Children's Hospital / Dept. Ophthalmology
Boston, Massachusetts, 02115, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
University of North Carolina/Ophthalmology
Chapel Hill, North Carolina, 27599-7040, United States
University of Pennsylvania/Scheie Eye Institute
Philadelphia, Pennsylvania, 19104, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Calgary Health
Calgary, Alberta, T2S-=2H4, Canada
Related Publications (1)
Bakri SJ, Snyder MR, Pulido JS, McCannel CA, Weiss WT, Singh RJ. Six-month stability of bevacizumab (Avastin) binding to vascular endothelial growth factor after withdrawal into a syringe and refrigeration or freezing. Retina. 2006 May-Jun;26(5):519-22. doi: 10.1097/01.iae.0000225354.92444.7a.
PMID: 16770257BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Michael T Trese, MD
Vision Research Foundation
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 19, 2008
First Posted
June 20, 2008
Study Start
June 1, 2008
Primary Completion
June 1, 2009
Study Completion
July 1, 2009
Last Updated
January 27, 2010
Record last verified: 2008-06