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

Completed · Phase 2

Conditions studied: Macular Degeneration

In brief

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.

Key facts

Study ID

NCT00259753

Run by

OPKO Health, Inc.

People needed

120

Starts

2005-07-01

Expected to finish

2007-12-01

Last updated by the study team

2008-08-05

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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