Clincosm LogoSign in Get a demo

Safety and Efficacy Study of Small Interfering Ribonucleic Acid (RNA) Molecule (Cand5) to Treat Wet Age-Related Macular Degeneration

Sponsor
OPKO Health, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00259753
Collaborator
(none)
120
Enrollment
23
Locations
3
Arms
29
Duration (Months)
5.2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
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
Study Start Date :
Jul 1, 2005
Actual Primary Completion Date :
Dec 1, 2007
Actual Study Completion Date :
Dec 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

0.2 mg/eye

Drug: Bevasiranib
Other Names:
  • Cand5

    		•
    Experimental: 2

    1.5 mg/eye

    Drug: Bevasiranib
    Other Names:
  • Cand5

    		•
    Experimental: 3

    3.0 mg/eye

    Drug: Bevasiranib
    Other Names:
  • Cand5

    		•

    Outcome Measures

    Primary Outcome Measures

    1. change from baseline at the 12-week evaluation in macular edema as measured by optical coherence tomography. [12 week]

    Secondary Outcome Measures

    1. The secondary endpoint is the mean BCVA line/letters change from baseline at the 12-week evaluation. [12 week]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    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
    5 Florida Eye Microsurgical Institute, Inc. Boynton Beach Florida United States 33426
    6 Retina Specialist Towson Maryland United States 21204
    7 Vitreo-Retinal Associates PC Grand Rapids Michigan United States 49525
    8 Associated Retinal Consultants Grand Rapids Michigan United States 49546
    9 Associated Retinal Consultants, P.C. Royal Oak Michigan United States 48073
    10 VitreoRetinal Surgery, P.A. Edina Minnesota United States 55435
    11 Eye Foundation of Kansas City, UMKC School of Medicine Kansas City Missouri United States 64108
    12 Retina-Vitreous Center Lakewood New Jersey United States 08701
    13 Retina-Vitreous Consultants Livingston New Jersey United States 07039
    14 OCLI Lynbrook New York United States 11563
    15 LuEsther T. Mertz Retinal Research Center New York New York United States 10021
    16 Southeast Clinical Research Charlotte North Carolina United States 28210
    17 Retina Associates of Cleveland Beachwood Ohio United States 44122
    18 Retina Associates of Cleveland, Inc. Lakewood Ohio United States 44107
    19 Black Hills Eye Institute Rapid City South Dakota United States 57701
    20 Retina Reseach Center Austin Texas United States 78705
    21 Ophthalmology Associates Fort Worth Texas United States 76102
    22 Vitreoretinal Consultants Houston TX Houston Texas United States 77030
    23 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00259753
    Other Study ID Numbers:
    • ACU201
    First Posted:
    Dec 1, 2005
    Last Update Posted:
    Aug 5, 2008
    Last Verified:
    Jul 1, 2008
    Keywords provided by , ,
    Wet Age-Related Macular Degeneration
    Additional relevant MeSH terms:
    Macular Degeneration

    Study Results

    No Results Posted as of Aug 5, 2008