Safety and Efficacy Study of Small Interfering Ribonucleic Acid (RNA) Molecule (Cand5) to Treat Wet Age-Related Macular Degeneration
- Registration Number
- NCT00259753
- Lead Sponsor
- OPKO Health, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Bevasiranib 1.5 mg/eye 1 Bevasiranib 0.2 mg/eye 3 Bevasiranib 3.0 mg/eye
- Primary Outcome Measures
Name Time Method change from baseline at the 12-week evaluation in macular edema as measured by optical coherence tomography. 12 week
- Secondary Outcome Measures
Name Time Method The secondary endpoint is the mean BCVA line/letters change from baseline at the 12-week evaluation. 12 week
Trial Locations
- Locations (23)
Associated Retinal Consultants, P.C.
🇺🇸Royal Oak, Michigan, United States
Retina-Vitreous Consultants
🇺🇸Livingston, New Jersey, United States
Vitreoretinal Consultants Houston TX
🇺🇸Houston, Texas, United States
Bay Area Retina Associates
🇺🇸Walnut Creek, California, United States
Florida Eye Microsurgical Institute, Inc.
🇺🇸Boynton Beach, Florida, United States
Associated Retinal Consultants
🇺🇸Grand Rapids, Michigan, United States
Eye Foundation of Kansas City, UMKC School of Medicine
🇺🇸Kansas City, Missouri, United States
Southeast Clinical Research
🇺🇸Charlotte, North Carolina, United States
Retina Reseach Center
🇺🇸Austin, Texas, United States
VitreoRetinal Surgery, P.A.
🇺🇸Edina, Minnesota, United States
OCLI
🇺🇸Lynbrook, New York, United States
LuEsther T. Mertz Retinal Research Center
🇺🇸New York, New York, United States
Vitreo-Retinal Associates PC
🇺🇸Grand Rapids, Michigan, United States
Retina Centers PC
🇺🇸Tucson, Arizona, United States
Medical College of Wisconsin Eye Institute
🇺🇸Milwaukee, Wisconsin, United States
Retina Associates of Cleveland
🇺🇸Beachwood, Ohio, United States
Retina-Vitreous Center
🇺🇸Lakewood, New Jersey, United States
Sall Research Medical Center
🇺🇸Artesia, California, United States
Acuity Participating Site
🇺🇸Phoenix, Arizona, United States
Retina Specialist
🇺🇸Towson, Maryland, United States
Black Hills Eye Institute
🇺🇸Rapid City, South Dakota, United States
Retina Associates of Cleveland, Inc.
🇺🇸Lakewood, Ohio, United States
Ophthalmology Associates
🇺🇸Fort Worth, Texas, United States