Safety and Efficacy Study of Small Interfering Ribonucleic Acid (RNA) Molecule (Cand5) to Treat Wet Age-Related Macular Degeneration
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ClinicalTrials.gov Identifier: NCT00259753 |
Recruitment Status
:
Completed
First Posted
: December 1, 2005
Last Update Posted
: August 5, 2008
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Sponsor:
OPKO Health, Inc.
Information provided by:
OPKO Health, Inc.
Tracking Information | ||||
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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 |
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 |
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Condition ICMJE | Macular Degeneration | |||
Intervention ICMJE | Drug: Bevasiranib
Other Name: Cand5 |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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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 |