Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

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
History of Changes

November 30, 2005
August 4, 2008
July 2005
December 2007   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00259753 on ClinicalTrials.gov Archive Site
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 ]
Not Provided
Not Provided
Not Provided
 
Safety and Efficacy Study of Small Interfering Ribonucleic Acid (RNA) Molecule (Cand5) to Treat Wet Age-Related Macular Degeneration
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Macular Degeneration
Drug: Bevasiranib
Other Name: Cand5
  • Experimental: 1
    0.2 mg/eye
    Intervention: Drug: Bevasiranib
  • Experimental: 2
    1.5 mg/eye
    Intervention: Drug: Bevasiranib
  • Experimental: 3
    3.0 mg/eye
    Intervention: Drug: Bevasiranib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
December 2007
December 2007   (final data collection date for primary outcome measure)

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.
Both
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00259753
ACU201
Yes
Not Provided
Not Provided
Denis O'Shaughnessy, Opko Health
OPKO Health, Inc.
Not Provided
Study Director: Denis O'Shaughnessy, PHD Opko Health
OPKO Health, Inc.
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP