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

August 4, 2008 updated by: OPKO Health, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85014
        • Acuity Participating Site
      • Tucson, Arizona, United States, 85704
        • Retina Centers PC
    • California
      • Artesia, California, United States, 90701
        • Sall Research Medical Center
      • Walnut Creek, California, United States, 94598
        • Bay Area Retina Associates
    • Florida
      • Boynton Beach, Florida, United States, 33426
        • Florida Eye Microsurgical Institute, Inc.
    • Maryland
      • Towson, Maryland, United States, 21204
        • Retina Specialist
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Associated Retinal Consultants
      • Grand Rapids, Michigan, United States, 49525
        • Vitreo-Retinal Associates PC
      • Royal Oak, Michigan, United States, 48073
        • Associated Retinal Consultants, P.C.
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • VitreoRetinal Surgery, P.A.
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Eye Foundation of Kansas City, UMKC School of Medicine
    • New Jersey
      • Lakewood, New Jersey, United States, 08701
        • Retina-Vitreous Center
      • Livingston, New Jersey, United States, 07039
        • Retina-Vitreous Consultants
    • New York
      • Lynbrook, New York, United States, 11563
        • OCLI
      • New York, New York, United States, 10021
        • LuEsther T. Mertz Retinal Research Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Southeast Clinical Research
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Retina Associates of Cleveland
      • Lakewood, Ohio, United States, 44107
        • Retina Associates of Cleveland, Inc.
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Black Hills Eye Institute
    • Texas
      • Austin, Texas, United States, 78705
        • Retina Reseach Center
      • Fort Worth, Texas, United States, 76102
        • Ophthalmology Associates
      • Houston, Texas, United States, 77030
        • Vitreoretinal Consultants Houston TX
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change from baseline at the 12-week evaluation in macular edema as measured by optical coherence tomography.
Time Frame: 12 week
12 week

Secondary Outcome Measures

Outcome Measure
Time Frame
The secondary endpoint is the mean BCVA line/letters change from baseline at the 12-week evaluation.
Time Frame: 12 week
12 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OPKO Health, Inc.

Investigators

  • Study Director: Denis O'Shaughnessy, PHD, OPKO Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (ACTUAL)

December 1, 2007

Study Completion (ACTUAL)

December 1, 2007

Study Registration Dates

First Submitted

November 30, 2005

First Submitted That Met QC Criteria

November 30, 2005

First Posted (ESTIMATE)

December 1, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

August 5, 2008

Last Update Submitted That Met QC Criteria

August 4, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACU201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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