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

Tracking Information

First Received Date ^ICMJE

November 30, 2005

Last Updated Date

August 4, 2008

Start Date ^ICMJE

July 2005

Primary Completion Date

December 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00259753 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Macular Degeneration

Intervention ^ICMJE

Drug: Bevasiranib

Other Name: Cand5

Study Arms

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

120

Completion Date

December 2007

Primary Completion Date

December 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients must have subfoveal classic, predominantly classic, or minimally classic lesions, secondary to AMD.
Patients must have ETDRS best corrected visual acuity of 64 to 24 letters (20/50 to 20/320 Snellen Equivalent) in the study eye.
Patients must be age 50 or older

Exclusion Criteria:

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.
Patients with advanced glaucoma (greater than 0.8 cup:disk) or intraocular pressure above 22 mmHg in the study eye.
Patients with any retinal vasculopathies, including diabetic retinopathy, retinal vein occlusions, etc. in the study eye.
Patients with any subfoveal scarring, atrophy, or hemorrhage in the study eye.
Patients whose CNV lesion in the study eye contains more than 25% scarring and/or atrophy.
Patients who have undergone any extrafoveal/juxtafoveal laser treatment of the study eye within two weeks prior to the screening visit.
Patients who received treatment with an investigational drug within 4 weeks prior to the screening visit.

Sex/Gender

Sexes Eligible for Study:

All

Ages

50 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00259753

Other Study ID Numbers ^ICMJE

ACU201

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Denis O'Shaughnessy, Opko Health

Study Sponsor ^ICMJE

OPKO Health, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Denis O'Shaughnessy, PHD

Opko Health

PRS Account

OPKO Health, Inc.

Verification Date

July 2008

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

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