Pan-VEGF Blockade for the Treatment of Retinopathy of Prematurity (BLOCK-ROP)

Withdrawn before enrolling · Phase 2

Conditions studied: Retinopathy of Prematurity

In brief

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.

Key facts

Study ID

NCT01232777

Run by

Vision Research Foundation

People needed

0

Starts

2012-06-01

Expected to finish

2018-07-01

Last updated by the study team

2013-10-17

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inborn babies at participating NICU's who meet inclusion criteria
• Outborn babies transferred to participating NICU's who meet inclusion criteria
• 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)
• 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)

Where it is running

• 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

Full record on ClinicalTrials.gov

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