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

Tracking Information
First Submitted Date ICMJE	November 30, 2005
First Posted Date ICMJE	December 1, 2005
Last Update Posted Date	August 5, 2008
Study Start Date ICMJE	July 2005
Actual Primary Completion Date	December 2007 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: July 24, 2008)	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; (submitted: July 24, 2008)	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
Actual Enrollment ICMJE; (submitted: November 30, 2005)	120
Original Enrollment ICMJE	Same as current
Actual Study Completion Date	December 2007
Actual 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	No
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