Status:
TERMINATED
Pan-VEGF Blockade for the Treatment of Retinopathy of Prematurity
Lead Sponsor:
Vision Research Foundation
Conditions:
Retinopathy of Prematurity
Eligibility:
All Genders
30-36 years
Phase:
PHASE1
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 th...
Eligibility Criteria
Inclusion
- Eligibility criteria
- Premature newborn infants with bilateral progressive APROP despite complete peripheral retinal ablation.
- Inborn babies at participating NICUs (must meet inclusion criteria 3 through 7)
- Outborn babies transferred to participating NICU (must meet inclusion criteria 3 through 7)
- 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
Exclusion
- 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)
- Neonatologist feels inclusion will unduly challenge the infant
- Refusal of initial consent
- Refusal of subsequent evaluation
- Media opacity precluding fundus visualization (eg: cataract)
- Any ocular or periocular infection(s)
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00702819
Start Date
June 1 2008
End Date
July 1 2009
Last Update
January 27 2010
Active Locations (11)
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1
Childrens Hospital
Los Angeles, California, United States, 90027
2
Jules Stein Eye Center
Los Angeles, California, United States, 90095
3
California Vitreoretinal Center
Menlo Park, California, United States, 94025
4
Bascom Palmer Eye Institute
Miami, Florida, United States, 33136