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

Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00259753
• Other study ID #: ACU201
• Status: Completed
• Phase: Phase 2
• First received: November 30, 2005
• Last updated: August 4, 2008
• Start date: July 2005
• Est. completion date: December 2007

Study information

• Verified date: July 2008
• Source: OPKO Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Macular Degeneration

Intervention

Drug:
• Bevasiranib

Locations

Country	Name	City	State
United States	Sall Research Medical Center	Artesia	California
United States	Retina Reseach Center	Austin	Texas
United States	Retina Associates of Cleveland	Beachwood	Ohio
United States	Florida Eye Microsurgical Institute, Inc.	Boynton Beach	Florida
United States	Southeast Clinical Research	Charlotte	North Carolina
United States	VitreoRetinal Surgery, P.A.	Edina	Minnesota
United States	Ophthalmology Associates	Fort Worth	Texas
United States	Associated Retinal Consultants	Grand Rapids	Michigan
United States	Vitreo-Retinal Associates PC	Grand Rapids	Michigan
United States	Vitreoretinal Consultants Houston TX	Houston	Texas
United States	Eye Foundation of Kansas City, UMKC School of Medicine	Kansas City	Missouri
United States	Retina Associates of Cleveland, Inc.	Lakewood	Ohio
United States	Retina-Vitreous Center	Lakewood	New Jersey
United States	Retina-Vitreous Consultants	Livingston	New Jersey
United States	OCLI	Lynbrook	New York
United States	Medical College of Wisconsin Eye Institute	Milwaukee	Wisconsin
United States	LuEsther T. Mertz Retinal Research Center	New York	New York
United States	Acuity Participating Site	Phoenix	Arizona
United States	Black Hills Eye Institute	Rapid City	South Dakota
United States	Associated Retinal Consultants, P.C.	Royal Oak	Michigan
United States	Retina Specialist	Towson	Maryland
United States	Retina Centers PC	Tucson	Arizona
United States	Bay Area Retina Associates	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
OPKO Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline at the 12-week evaluation in macular edema as measured by optical coherence tomography.		12 week	No
Secondary	The secondary endpoint is the mean BCVA line/letters change from baseline at the 12-week evaluation.		12 week	No

External Links

•   Sponsor