Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD

NCT00499590 | Terminated Phase 3 Results DMC

• 1 other identifier: ACU301
• Study Type: interventional
• Target: 338
• Locations: 2 countries
• Sites: 60

Brief Summary

The purpose of this study is to compare the safety and effectiveness of bevasiranib given either every 8 weeks or every 12 weeks after an initial pre-treatment with 3 injections of Lucentis® (ranibizumab injection) compared to Lucentis® given every 4 weeks to people with wet AMD. Patients will be assigned at random (like tossing a coin) to receive one of three treatments options for 104 weeks.

Conditions

Macular Degeneration

Keywords

AMD; Macular Degeneration; bevasiranib; COBALT study; age related macular degeneration; wet AMD; wet age related macular degeneration

Outcome Measures

Primary Outcomes (1)

• Visual Acuity

  avoidance of 3 or more lines of vision loss

  week 60

Secondary Outcomes (1)

• Need for Rescue Therapy, Time to Rescue Therapy, and Number of Patients With a 3 or More Line Gain in Vision

  Week 60

Study Arms (3)

A

ACTIVE COMPARATOR

Lucentis® (0.5mg) every 4 weeks.

Drug: ranibizumab

B

EXPERIMENTAL

Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 \& 6.

Drug: bevasiranib

C

EXPERIMENTAL

Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 \& 6.

Drug: bevasiranib

Interventions

bevasiranib DRUG

Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks

B; C

ranibizumab DRUG

Lucentis® (0.5 mg)administered intravitreally every 4 weeks.

Also known as: Lucentis®

A

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be age 50 years or older
• Patients must have predominantly classic, minimally classic or occult with no classic lesions secondary to Age Related Macular Degeneration.
• The study eye must have ETDRS best corrected visual acuity of 69 to 24 letters (20/40 to 20/320 Snellen equivalent).
• Patients must be willing and able to return for scheduled monthly follow-up visits for two-years.

You may not qualify if:

• Prior pharmacologic treatment for AMD in the study (patients can not have previously received Avastin®/Lucentis®, Macugen®, or any other anti-VEGF agents, steroid treatments, PDT, radiation treatment, or any experimental therapies for AMD in the study eye)
• Any intraocular surgery of the study eye within 12 weeks of screening
• Previous posterior vitrectomy of the study eye
• Advanced glaucoma or intraocular pressure above 22 mm Hg in the study eye despite treatment.

Sponsors & Collaborators

• OPKO Health, Inc.: lead

Study Sites (60)

Retinal Consultants of Arizona (site 209)

Phoenix, Arizona, 85014, United States

Location

Associated Retina Consultants (site 286)

Phoenix, Arizona, 85020, United States

Location

Retina Centers PC (site 215)

Tucson, Arizona, 85704, United States

Location

Eye Medical Center (site 287)

Fresno, California, 93720, United States

Location

Northern California Retina Vitreous Associates (site 320)

Mountain View, California, 94040, United States

Location

Retina Institute of California (site 207)

Pasadena, California, 91105, United States

Location

Retina Consultants San Diego (site 232)

Poway, California, 93064, United States

Location

Retinal Consultants Medical Group (site 289)

Sacramento, California, 95819, United States

Location

Orange County Retina Medical Group (site 252)

Santa Ana, California, 92705, United States

Location

Miramar Eye Specialists Medical Group (site 245)

Ventura, California, 93003, United States

Location

The Eye Care Group, PC (site 315)

Waterbury, Connecticut, 06708, United States

Location

Florida Eye Clinic (site 257)

Altamonte Springs, Florida, 32701, United States

Location

Florida Eye Microsurgical Institute, Inc. (site 217)

Boynton Beach, Florida, 33426, United States

Location

Retina Health Center (site 247)

Fort Myers, Florida, 33901, United States

Location

National Ophthalmic Research Institute at Retina Consultants of SW Florida (site 270)

Fort Myers, Florida, 33912, United States

Location

Magruder Eye Institute (site 264)

Orlando, Florida, 32803, United States

Location

Southern Vitreoretinal Associates, PL (site 309)

Tallahassee, Florida, 32308, United States

Location

University of South Florida Eye Institute (site 311)

Tampa, Florida, 33612, United States

Location

Center for Retina and Macular Disease (site 293)

Winter Haven, Florida, 33880, United States

Location

Southeast Retina Center (site 268)

Augusta, Georgia, 30909, United States

Location

Midwest Eye Institute (site 253)

Indianapolis, Indiana, 46280, United States

Location

Retina Associates, PA (site 295)

Shawnee Mission, Kansas, 66204, United States

Location

Vitreo-Retinal Consultants & Surgeons, P.A. (site 274)

Wichita, Kansas, 67214, United States

Location

Eye Centers of Louisville (site 251)

Louisville, Kentucky, 40207, United States

Location

Retina Specialists (site 231)

Towson, Maryland, 21204, United States

Location

Retina Associates St. Louis (site 300)

Florissant, Missouri, 63031, United States

Location

Eye Foundation of Kansas City Truman Medical Center (site 272)

Kansas City, Missouri, 64108, United States

Location

Retinal Consultants of Nevada (site 273)

Las Vegas, Nevada, 89144, United States

Location

Eyesight Ophthalmic Services, PA (site 290)

Portsmouth, New Hampshire, 03801, United States

Location

Delaware Valley Retina Associates (site 261)

Lawrenceville, New Jersey, 08648, United States

Location

Retina-Vitreous Consultants (site 216)

Livingston, New Jersey, 07039, United States

Location

Retina Associates of New Jersey (site 298)

Teaneck, New Jersey, 07666, United States

Location

Capital Region Retina (site 316)

Albany, New York, 12206, United States

Location

New York Eye & Ear Infirmary (site 272)

New York, New York, 10003, United States

Location

Vitreous-Retina-Macula Consultants of New York (site 239)

New York, New York, 10022, United States

Location

Carolina Eye Associates (site 308)

Southern Pines, North Carolina, 28387, United States

Location

Retina Associates of Cleveland (site 228)

Beachwood, Ohio, 44122, United States

Location

Cincinnati Eye Institute (site 285)

Cincinnati, Ohio, 45242, United States

Location

Retina Associates of Cleveland, Inc. (site 219)

Lakewood, Ohio, 44107, United States

Location

Retina-Vitreous Associates (site 266)

Toledo, Ohio, 43608, United States

Location

Retina and Vitreous Center of Southern Oregon (site 271)

Ashland, Oregon, 97520, United States

Location

Ophthalmology Associates of PA (site 297)

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Palmetto Retina Center (site 275)

West Columbia, South Carolina, 29169, United States

Location

Black Hills Regional Eye Institute (site 202)

Rapid City, South Dakota, 57701, United States

Location

Southeastern Retina Associates, PC (Site 250)

Knoxville, Tennessee, 37909, United States

Location

Retina Research Institute of Texas, L.L.C. (site 269)

Abilene, Texas, 79606, United States

Location

Austin Retina Associates (site 304)

Austin, Texas, 78705, United States

Location

Retina Research Center (site 204)

Austin, Texas, 78705, United States

Location

University of Texas Medical Branch- Galveston (site 301

Galveston, Texas, 77555, United States

Location

Houston Eye Associates (site 321)

Houston, Texas, 77025, United States

Location

Valley Retina Institue, PA (site 258)

McAllen, Texas, 78503, United States

Location

Eye Care Associates of East Texas (site 282)

Tyler, Texas, 75701, United States

Location

Rocky Mountain Retina Consultants (site 256)

Salt Lake City, Utah, 84107, United States

Location

University of Utah, John A. Moran Eye Center (site 205)

Salt Lake City, Utah, 84132, United States

Location

University of Virginia- Ophthalmology Dept. (site 254)

Charlottesville, Virginia, 22908, United States

Location

Calgary Retina Consultants (site 318)

Calgary, Alberta, T3E 7M8, Canada

Location

Ivey Eye Institute (site 314)

London, Ontario, N6A 4G5, Canada

Location

Canadian Centre for Advanced Eye Therapeutics (site 291)

Mississauga, Ontario, L4W 1W9, Canada

Location

Sunnybrook Health Sciences Centre (site 305)

Toronto, Ontario, M4N 3M5, Canada

Location

Eye Centre Pasqua Hospital (site 299)

Regina, Saskatchewan, S4T 1A5, Canada

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

bevasiranib; Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

Study was terminated early.

Results Point of Contact

• Title: Jane Hsiao, PhD, MBA
• Organization: OPKO Health, Inc.

jhsiao@opko.com

305-575-6004

Study Officials

• Denis O'Shaughnessy, Ph.D.

  Senior VP of Clincial Development

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2007
• First Posted: July 11, 2007
• Study Start: August 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: May 1, 2009
• Last Updated: October 6, 2014
• Results First Posted: October 6, 2014

Record last verified: 2014-09

Locations

CA (5); US (55)