A Safety Study of CNTO 2476 in Patients With Age-Related Macular Degeneration
Completed · Phase 1/Phase 2
Conditions studied: Age-related Macular Degeneration
In brief
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 acuity (acuteness or clearness of vision) impairment associated with the geographic atrophy (GA: partial or complete wasting away of retinal layer below the retina) manifestation of age-related macular degeneration (AMD: medical condition which usually affects older adults and results in a loss of vision in the center of the visual field \[the macula\] because of damage to the retina).
Key facts
- Study ID
- NCT01226628
- Run by
- Janssen Research & Development, LLC
- People needed
- 39
- Starts
- 2010-10-21
- Expected to finish
- 2017-05-31
- Last updated by the study team
- 2017-08-08
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Study site — Arcadia, California, United States
- Study site — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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