Clinical trial NCT00259753: Safety and Efficacy Study of Small Interfering Ribonucleic Acid (RNA) Molecule (Cand5) to Treat Wet Age-Related Macular Degeneration
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Macular Degeneration
Keywords: Wet Age-Related Macular Degeneration
Lead sponsor: OPKO Health, Inc.
Sponsor class: INDUSTRY
First posted: 2005-12-01
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: change from baseline at the 12-week evaluation in macular edema as measured by optical coherence tomography.
timeFrame: 12 week
Secondary outcomes:
measure: The secondary endpoint is the mean BCVA line/letters change from baseline at the 12-week evaluation.
timeFrame: 12 week
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Acuity Participating Site
state: Arizona
city: Tucson
country: United States
facility: Retina Centers PC
state: Arizona
city: Artesia
country: United States
facility: Sall Research Medical Center
state: California
city: Walnut Creek
country: United States
facility: Bay Area Retina Associates
state: California
city: Boynton Beach
country: United States
facility: Florida Eye Microsurgical Institute, Inc.
state: Florida
city: Towson
country: United States
facility: Retina Specialist
state: Maryland
city: Grand Rapids
country: United States
facility: Vitreo-Retinal Associates PC
state: Michigan
city: Grand Rapids
country: United States
facility: Associated Retinal Consultants
state: Michigan
city: Royal Oak
country: United States
facility: Associated Retinal Consultants, P.C.
state: Michigan
city: Edina
country: United States
facility: VitreoRetinal Surgery, P.A.
state: Minnesota
city: Kansas City
country: United States
facility: Eye Foundation of Kansas City, UMKC School of Medicine
state: Missouri
city: Lakewood
country: United States
facility: Retina-Vitreous Center
state: New Jersey
city: Livingston
country: United States
facility: Retina-Vitreous Consultants
state: New Jersey
city: Lynbrook
country: United States
facility: OCLI
state: New York
city: New York
country: United States
facility: LuEsther T. Mertz Retinal Research Center
state: New York
city: Charlotte
country: United States
facility: Southeast Clinical Research
state: North Carolina
city: Beachwood
country: United States
facility: Retina Associates of Cleveland
state: Ohio
city: Lakewood
country: United States
facility: Retina Associates of Cleveland, Inc.
state: Ohio
city: Rapid City
country: United States
facility: Black Hills Eye Institute
state: South Dakota
city: Austin
country: United States
facility: Retina Reseach Center
state: Texas
city: Fort Worth
country: United States
facility: Ophthalmology Associates
state: Texas
city: Houston
country: United States
facility: Vitreoretinal Consultants Houston TX
state: Texas
city: Milwaukee
country: United States
facility: Medical College of Wisconsin Eye Institute
state: Wisconsin
Study officials:
affiliation: Opko Health
name: Denis O'Shaughnessy, PHD
role: STUDY_DIRECTOR
References: