Status:
COMPLETED
A Safety Study of CNTO 2476 in Patients With Age-Related Macular Degeneration
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE1
PHASE2
Brief Summary
The main purpose of this study to evaluate the safety and tolerability of CNTO 2476 administered subretinally (beneath the retina) using the iTrack Model 275 micro catheter in patients with visual acu...
Detailed Description
The study is a Phase 1/2a, multicenter, randomized (the study medication is assigned by chance), single dose, dose escalation, fellow-eye controlled study evaluating the safety and clinical response o...
Eligibility Criteria
Inclusion
- Women must be incapable of childbearing
- Patient must be a suitable candidate for ophthalmologic surgery, is willing and able to comply with the surgical procedure, scheduled visits, treatment plan, laboratory tests and other study procedures
- Confirmed diagnosis of bilateral geographic atrophy (GA) of the macula bilaterally caused by age-related macular degeneration
Exclusion
- Evidence of exudative ("wet") age -related macular degeneration in either eye
- Evidence of other significant ophthalmologic disease (eg, glaucoma)
- Ocular hypertension
- Previous cell therapy other than blood components
- Previous treatment for age-related macular degeneration (AMD) other than antioxidant or zinc supplements or other oral vitamin supplements
Key Trial Info
Start Date :
October 21 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2017
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT01226628
Start Date
October 21 2010
End Date
May 31 2017
Last Update
August 8 2017
Active Locations (2)
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1
Arcadia, California, United States
2
Philadelphia, Pennsylvania, United States