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

NCT ID: NCT00259753

Last Updated: 2008-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Macular Degeneration

Keywords

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Wet Age-Related Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

0.2 mg/eye

Group Type EXPERIMENTAL

Bevasiranib

Intervention Type DRUG

2

1.5 mg/eye

Group Type EXPERIMENTAL

Bevasiranib

Intervention Type DRUG

3

3.0 mg/eye

Group Type EXPERIMENTAL

Bevasiranib

Intervention Type DRUG

Interventions

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Bevasiranib

Intervention Type DRUG

Other Intervention Names

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Cand5

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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OPKO Health, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Opko Health

Principal Investigators

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Denis O'Shaughnessy, PHD

Role: STUDY_DIRECTOR

Opko Health

Locations

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Acuity Participating Site

Phoenix, Arizona, United States

Site Status

Retina Centers PC

Tucson, Arizona, United States

Site Status

Sall Research Medical Center

Artesia, California, United States

Site Status

Bay Area Retina Associates

Walnut Creek, California, United States

Site Status

Florida Eye Microsurgical Institute, Inc.

Boynton Beach, Florida, United States

Site Status

Retina Specialist

Towson, Maryland, United States

Site Status

Vitreo-Retinal Associates PC

Grand Rapids, Michigan, United States

Site Status

Associated Retinal Consultants

Grand Rapids, Michigan, United States

Site Status

Associated Retinal Consultants, P.C.

Royal Oak, Michigan, United States

Site Status

VitreoRetinal Surgery, P.A.

Edina, Minnesota, United States

Site Status

Eye Foundation of Kansas City, UMKC School of Medicine

Kansas City, Missouri, United States

Site Status

Retina-Vitreous Center

Lakewood, New Jersey, United States

Site Status

Retina-Vitreous Consultants

Livingston, New Jersey, United States

Site Status

OCLI

Lynbrook, New York, United States

Site Status

LuEsther T. Mertz Retinal Research Center

New York, New York, United States

Site Status

Southeast Clinical Research

Charlotte, North Carolina, United States

Site Status

Retina Associates of Cleveland

Beachwood, Ohio, United States

Site Status

Retina Associates of Cleveland, Inc.

Lakewood, Ohio, United States

Site Status

Black Hills Eye Institute

Rapid City, South Dakota, United States

Site Status

Retina Reseach Center

Austin, Texas, United States

Site Status

Ophthalmology Associates

Fort Worth, Texas, United States

Site Status

Vitreoretinal Consultants Houston TX

Houston, Texas, United States

Site Status

Medical College of Wisconsin Eye Institute

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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ACU201

Identifier Type: -

Identifier Source: org_study_id