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

Primary Purpose

Macular Degeneration

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bevasiranib
Sponsored by
OPKO Health, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration focused on measuring Wet Age-Related Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Acuity Participating Site
  • Retina Centers PC
  • Sall Research Medical Center
  • Bay Area Retina Associates
  • Florida Eye Microsurgical Institute, Inc.
  • Retina Specialist
  • Vitreo-Retinal Associates PC
  • Associated Retinal Consultants
  • Associated Retinal Consultants, P.C.
  • VitreoRetinal Surgery, P.A.
  • Eye Foundation of Kansas City, UMKC School of Medicine
  • Retina-Vitreous Center
  • Retina-Vitreous Consultants
  • OCLI
  • LuEsther T. Mertz Retinal Research Center
  • Southeast Clinical Research
  • Retina Associates of Cleveland
  • Retina Associates of Cleveland, Inc.
  • Black Hills Eye Institute
  • Retina Reseach Center
  • Ophthalmology Associates
  • Vitreoretinal Consultants Houston TX
  • Medical College of Wisconsin Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

1

2

3

Arm Description

0.2 mg/eye

1.5 mg/eye

3.0 mg/eye

Outcomes

Primary Outcome Measures

change from baseline at the 12-week evaluation in macular edema as measured by optical coherence tomography.

Secondary Outcome Measures

The secondary endpoint is the mean BCVA line/letters change from baseline at the 12-week evaluation.

Full Information

First Posted
November 30, 2005
Last Updated
August 4, 2008
Sponsor
OPKO Health, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00259753
Brief Title
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

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
OPKO Health, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
Keywords
Wet Age-Related Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
0.2 mg/eye
Arm Title
2
Arm Type
Experimental
Arm Description
1.5 mg/eye
Arm Title
3
Arm Type
Experimental
Arm Description
3.0 mg/eye
Intervention Type
Drug
Intervention Name(s)
Bevasiranib
Other Intervention Name(s)
Cand5
Primary Outcome Measure Information:
Title
change from baseline at the 12-week evaluation in macular edema as measured by optical coherence tomography.
Time Frame
12 week
Secondary Outcome Measure Information:
Title
The secondary endpoint is the mean BCVA line/letters change from baseline at the 12-week evaluation.
Time Frame
12 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denis O'Shaughnessy, PHD
Organizational Affiliation
Opko Health
Official's Role
Study Director
Facility Information:
Facility Name
Acuity Participating Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Facility Name
Retina Centers PC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Sall Research Medical Center
City
Artesia
State/Province
California
ZIP/Postal Code
90701
Country
United States
Facility Name
Bay Area Retina Associates
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Florida Eye Microsurgical Institute, Inc.
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
Retina Specialist
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Vitreo-Retinal Associates PC
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49525
Country
United States
Facility Name
Associated Retinal Consultants
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Associated Retinal Consultants, P.C.
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
VitreoRetinal Surgery, P.A.
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Eye Foundation of Kansas City, UMKC School of Medicine
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Retina-Vitreous Center
City
Lakewood
State/Province
New Jersey
ZIP/Postal Code
08701
Country
United States
Facility Name
Retina-Vitreous Consultants
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
OCLI
City
Lynbrook
State/Province
New York
ZIP/Postal Code
11563
Country
United States
Facility Name
LuEsther T. Mertz Retinal Research Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Southeast Clinical Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Retina Associates of Cleveland
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Retina Associates of Cleveland, Inc.
City
Lakewood
State/Province
Ohio
ZIP/Postal Code
44107
Country
United States
Facility Name
Black Hills Eye Institute
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Retina Reseach Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Ophthalmology Associates
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76102
Country
United States
Facility Name
Vitreoretinal Consultants Houston TX
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Medical College of Wisconsin Eye Institute
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.opko.com
Description
Sponsor

Learn more about this trial

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

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