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

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 II

Genetics Home Reference related topics:

X-linked juvenile retinoschisis

MedlinePlus related topics:

Macular Degeneration

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study

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

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
1: Experimental 0.2 mg/eye	Drug: Bevasiranib
2: Experimental 1.5 mg/eye	Drug: Bevasiranib
3: Experimental 3.0 mg/eye	Drug: Bevasiranib

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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

Sponsor

This link exits the ClinicalTrials.gov site

Responsible Party:	Opko Health ( Denis O'Shaughnessy )
Study ID Numbers:	ACU201
First Received:	November 30, 2005
Last Updated:	August 4, 2008
ClinicalTrials.gov Identifier:	NCT00259753
Health Authority:	United States: Food and Drug Administration