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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00259753

  Show 23 Study Locations
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 October 19, 2014