Safety and Efficacy Study of Small Interfering Ribonucleic Acid (RNA) Molecule (Cand5) to Treat Wet Age-Related Macular Degeneration
This study has been completed.
Sponsor:
Opko Health, Inc.
Information provided by:
Opko Health, Inc.
ClinicalTrials.gov Identifier:
NCT00259753
First received: November 30, 2005
Last updated: August 4, 2008
Last verified: July 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Macular Degeneration |
Drug: Bevasiranib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase II, Randomized, Double-Masked, Controlled, Dose Comparison Study of Cand5 for Intravitreal Injection for the Treatment of Subfoveal Choroidal Neovascularization Associated With Wet Age-Related Macular Degeneration |
Resource links provided by NLM:
Genetics Home Reference related topics:
age-related macular degeneration
X-linked juvenile retinoschisis
MedlinePlus related topics:
Macular Degeneration
U.S. FDA Resources
Further study details as provided by Opko Health, Inc.:
Primary Outcome Measures:
- change from baseline at the 12-week evaluation in macular edema as measured by optical coherence tomography. [ Time Frame: 12 week ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The secondary endpoint is the mean BCVA line/letters change from baseline at the 12-week evaluation. [ Time Frame: 12 week ] [ Designated as safety issue: No ]
| Enrollment: | 120 |
| Study Start Date: | July 2005 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
0.2 mg/eye
|
Drug: Bevasiranib
Other Name: Cand5
|
|
Experimental: 2
1.5 mg/eye
|
Drug: Bevasiranib
Other Name: Cand5
|
|
Experimental: 3
3.0 mg/eye
|
Drug: Bevasiranib
Other Name: Cand5
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00259753
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Hide Study LocationsLocations
| United States, Arizona | |
| Acuity Participating Site | |
| Phoenix, Arizona, United States, 85014 | |
| Retina Centers PC | |
| Tucson, Arizona, United States, 85704 | |
| United States, California | |
| Sall Research Medical Center | |
| Artesia, California, United States, 90701 | |
| Bay Area Retina Associates | |
| Walnut Creek, California, United States, 94598 | |
| United States, Florida | |
| Florida Eye Microsurgical Institute, Inc. | |
| Boynton Beach, Florida, United States, 33426 | |
| United States, Maryland | |
| Retina Specialist | |
| Towson, Maryland, United States, 21204 | |
| United States, Michigan | |
| Vitreo-Retinal Associates PC | |
| Grand Rapids, Michigan, United States, 49525 | |
| Associated Retinal Consultants | |
| Grand Rapids, Michigan, United States, 49546 | |
| Associated Retinal Consultants, P.C. | |
| Royal Oak, Michigan, United States, 48073 | |
| United States, Minnesota | |
| VitreoRetinal Surgery, P.A. | |
| Edina, Minnesota, United States, 55435 | |
| United States, Missouri | |
| Eye Foundation of Kansas City, UMKC School of Medicine | |
| Kansas City, Missouri, United States, 64108 | |
| United States, New Jersey | |
| Retina-Vitreous Center | |
| Lakewood, New Jersey, United States, 08701 | |
| Retina-Vitreous Consultants | |
| Livingston, New Jersey, United States, 07039 | |
| United States, New York | |
| OCLI | |
| Lynbrook, New York, United States, 11563 | |
| LuEsther T. Mertz Retinal Research Center | |
| New York, New York, United States, 10021 | |
| United States, North Carolina | |
| Southeast Clinical Research | |
| Charlotte, North Carolina, United States, 28210 | |
| United States, Ohio | |
| Retina Associates of Cleveland | |
| Beachwood, Ohio, United States, 44122 | |
| Retina Associates of Cleveland, Inc. | |
| Lakewood, Ohio, United States, 44107 | |
| United States, South Dakota | |
| Black Hills Eye Institute | |
| Rapid City, South Dakota, United States, 57701 | |
| United States, Texas | |
| Retina Reseach Center | |
| Austin, Texas, United States, 78705 | |
| Ophthalmology Associates | |
| Fort Worth, Texas, United States, 76102 | |
| Vitreoretinal Consultants Houston TX | |
| Houston, Texas, United States, 77030 | |
| United States, Wisconsin | |
| Medical College of Wisconsin Eye Institute | |
| Milwaukee, Wisconsin, United States, 53226 | |
Sponsors and Collaborators
Opko Health, Inc.
Investigators
| Study Director: | Denis O'Shaughnessy, PHD | Opko Health |
More Information
Additional Information:
No publications provided
| Responsible Party: | Denis O'Shaughnessy, Opko Health |
| ClinicalTrials.gov Identifier: | NCT00259753 History of Changes |
| Other Study ID Numbers: | ACU201 |
| Study First Received: | November 30, 2005 |
| Last Updated: | August 4, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Opko Health, Inc.:
|
Wet Age-Related Macular Degeneration |
Additional relevant MeSH terms:
|
Macular Degeneration Choroidal Neovascularization Retinal Degeneration Retinal Diseases Eye Diseases |
Choroid Diseases Uveal Diseases Neovascularization, Pathologic Metaplasia Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013