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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:
ClinicalTrials.gov Identifier:
NCT00259753
First Posted: December 1, 2005
Last Update Posted: August 5, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
OPKO Health, Inc.
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


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 ]

Secondary Outcome Measures:
  • The secondary endpoint is the mean BCVA line/letters change from baseline at the 12-week evaluation. [ Time Frame: 12 week ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have subfoveal classic, predominantly classic, or minimally classic lesions, secondary to AMD.
  2. Patients must have ETDRS best corrected visual acuity of 64 to 24 letters (20/50 to 20/320 Snellen Equivalent) in the study eye.
  3. Patients must be age 50 or older

Exclusion Criteria:

  1. 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.
  2. Patients with advanced glaucoma (greater than 0.8 cup:disk) or intraocular pressure above 22 mmHg in the study eye.
  3. Patients with any retinal vasculopathies, including diabetic retinopathy, retinal vein occlusions, etc. in the study eye.
  4. Patients with any subfoveal scarring, atrophy, or hemorrhage in the study eye.
  5. Patients whose CNV lesion in the study eye contains more than 25% scarring and/or atrophy.
  6. Patients who have undergone any extrafoveal/juxtafoveal laser treatment of the study eye within two weeks prior to the screening visit.
  7. Patients who received treatment with an investigational drug within 4 weeks prior to the screening visit.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00259753


  Hide Study Locations
Locations
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:
Responsible Party: Denis O'Shaughnessy, Opko Health
ClinicalTrials.gov Identifier: NCT00259753     History of Changes
Other Study ID Numbers: ACU201
First Submitted: November 30, 2005
First Posted: December 1, 2005
Last Update Posted: August 5, 2008
Last Verified: July 2008

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