Status:
COMPLETED
Safety and Efficacy Study of Small Interfering Ribonucleic Acid (RNA) Molecule (Cand5) to Treat Wet Age-Related Macular Degeneration
Lead Sponsor:
OPKO Health, Inc.
Conditions:
Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
The objective of this study is to evaluate the safety and preliminary efficacy of three doses of Cand5. Cand5, a small interfering RNA molecule that selectively silences the mRNA encoding for VEGF.
Eligibility Criteria
Inclusion
- Patients must have subfoveal classic, predominantly classic, or minimally classic lesions, secondary to AMD.
- Patients must have ETDRS best corrected visual acuity of 64 to 24 letters (20/50 to 20/320 Snellen Equivalent) in the study eye.
- Patients must be age 50 or older
Exclusion
- Patients who have received prior treatment with any investigational new drug or device for wet AMD in the study eye within 24 weeks of the screening visit.
- Patients with advanced glaucoma (greater than 0.8 cup:disk) or intraocular pressure above 22 mmHg in the study eye.
- Patients with any retinal vasculopathies, including diabetic retinopathy, retinal vein occlusions, etc. in the study eye.
- Patients with any subfoveal scarring, atrophy, or hemorrhage in the study eye.
- Patients whose CNV lesion in the study eye contains more than 25% scarring and/or atrophy.
- Patients who have undergone any extrafoveal/juxtafoveal laser treatment of the study eye within two weeks prior to the screening visit.
- Patients who received treatment with an investigational drug within 4 weeks prior to the screening visit.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00259753
Start Date
July 1 2005
End Date
December 1 2007
Last Update
August 5 2008
Active Locations (23)
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1
Acuity Participating Site
Phoenix, Arizona, United States, 85014
2
Retina Centers PC
Tucson, Arizona, United States, 85704
3
Sall Research Medical Center
Artesia, California, United States, 90701
4
Bay Area Retina Associates
Walnut Creek, California, United States, 94598