Status:
WITHDRAWN
Pan-VEGF Blockade for the Treatment of Retinopathy of Prematurity (BLOCK-ROP)
Lead Sponsor:
Vision Research Foundation
Conditions:
Retinopathy of Prematurity
Eligibility:
All Genders
30-36 years
Phase:
PHASE2
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...
Detailed Description
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 th...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01232777
Start Date
June 1 2012
End Date
July 1 2018
Last Update
October 17 2013
Active Locations (19)
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1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
2
Jules Stein Eye Institute, UCLA
Los Angeles, California, United States, 90095
3
Eye Insitute at Stanford
Palo Alto, California, United States, 94303
4
Bascon Palmer Eye Institute
Miami, Florida, United States, 33136