Study Stopped
Lack of funding
Pan-VEGF Blockade for the Treatment of Retinopathy of Prematurity (BLOCK-ROP)
BLOCK-ROP
1 other identifier
interventional
N/A
2 countries
19
Brief Summary
The purpose of this study is to determine whether a single intravitreal (into the gel of the eye) injection of Avastin 0.625mg or 0.75mg is equivalent (non-inferior) to treatment with standard of care laser in infants with Type I pre-threshold retinopathy of prematurity (ROP) diagnosed at 30-36 weeks gestational age.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2012
Longer than P75 for phase_2
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2010
CompletedFirst Posted
Study publicly available on registry
November 2, 2010
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedOctober 17, 2013
October 1, 2013
2.8 years
October 26, 2010
October 16, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To demonstrate non-inferiority of Anti-VEGF treatment to standard-of-care laser
It is the intent of this clinical study to develop alternative therapy (a single bevacizumab injection) to standard therapy (laser ablation) and to show that bevacizumab is as safe and efficacious as laser.
With patient #58, 116 and 174 (within 3 months after each patient being enrolled)
Secondary Outcomes (1)
Decreased laser ablation and improved vascular maturity
With patient #58, 116 & 174 (within 3 months after each patient being enrolled)
Study Arms (3)
Bevacizumab (Avastin) 0.75mg/0.03cc
ACTIVE COMPARATOR1/3 of study participants will be randomized to this treatment in one eye (study eye) and the other eye will receive laser (fellow eye)
Bevacizumab (Avastin) 0.625mg/0.025cc
ACTIVE COMPARATOR1/3 of patients will be randomized to this treatment in 1 eye (study eye) and the other eye will receive laser (fellow eye).
Laser ablation
ACTIVE COMPARATOR1/3 of study participants will be randomized to this treatment in both eyes (study eye and fellow eye)
Interventions
A single dosage of: 0.625mg(0.025cc)or 0.75mg(0.03cc) will be given intravitreally.
Eligibility Criteria
You may qualify if:
- Type 1 pre-threshold ROP
- No prior treatment
- Post menstrual age less than 36 1/7 weeks
- Post menstrual age greater than 30 weeks
You may not qualify if:
- Fatal systemic anomaly
- An ocular anomaly of one or both eye affecting the retina or choroid
- An ocular anomaly precluding use of the RetCam (ex., microphthalmia)
- Refusal of initial consent
- Refusal of subsequent evaluation
- Media opacity precluding fundus visualization (ex., cataract)
- Any ocular or periocular infection(s)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
Jules Stein Eye Institute, UCLA
Los Angeles, California, 90095, United States
Eye Insitute at Stanford
Palo Alto, California, 94303, United States
Bascon Palmer Eye Institute
Miami, Florida, 33136, United States
Emory Eye Center
Atlanta, Georgia, 30322, United States
Children's Hospital, Dept. of Ophthalmology
Boston, Massachusetts, 02115, United States
Associated Retinal Consultants/William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Insitute of Ophthalmology and Medical Science, New Jersey Medical School
Newark, New Jersey, 07103, United States
Department of Ophthalmology, Weill Cornell Medical College
New York, New York, 10021, United States
Abrahamson Pediatric Eye Institute, Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Cleveland Clinic
Cleveland, Ohio, 44105, United States
Midwest Retina
Dublin, Ohio, 43016, United States
University Hospitals Eye Insitute, Rainbow Babies & Children's Hospital
Mayfield Heights, Ohio, 44134, United States
St. Christopher's Hospital for Children, Drexel Univ. School of Medicine
Philadelphia, Pennsylvania, 19134, United States
Austin Retina Associates
Austin, Texas, 78705, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
University of Utah, Moran Eye Center
Salt Lake City, Utah, 84132, United States
Medical College of Wisconsin--Eye Insititute
Milwaukee, Wisconsin, 53266, United States
Ells Retina Centre
Calgary, Alberta, T2T 5R6, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael T Trese, MD
Vision Research Foundation
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- VitreoRetinal Surgeon & Researcher
Study Record Dates
First Submitted
October 26, 2010
First Posted
November 2, 2010
Study Start
June 1, 2012
Primary Completion
April 1, 2015
Study Completion
July 1, 2018
Last Updated
October 17, 2013
Record last verified: 2013-10