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:
Information provided by:
Opko Health, Inc.
ClinicalTrials.gov Identifier:
NCT00259753
First received: November 30, 2005
Last updated: August 4, 2008
Last verified: July 2008
  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:


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:

  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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
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 April 17, 2014