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

Last updated: September 29, 2014
Sponsor: OPKO Health, Inc.
Overall Status: Terminated

Phase

3

Condition

Macular Degeneration

Geographic Atrophy

Treatment

N/A

Clinical Study ID

NCT00499590
ACU301
  • Ages > 50
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients must be age 50 years or older

  2. Patients must have predominantly classic, minimally classic or occult with no classiclesions secondary to Age Related Macular Degeneration.

  3. The study eye must have ETDRS best corrected visual acuity of 69 to 24 letters (20/40to 20/320 Snellen equivalent).

  4. Patients must be willing and able to return for scheduled monthly follow-up visits fortwo-years.

Exclusion

Exclusion Criteria:

  1. Prior pharmacologic treatment for AMD in the study (patients can not have previouslyreceived Avastin®/Lucentis®, Macugen®, or any other anti-VEGF agents, steroidtreatments, PDT, radiation treatment, or any experimental therapies for AMD in thestudy eye)

  2. Any intraocular surgery of the study eye within 12 weeks of screening

  3. Previous posterior vitrectomy of the study eye

  4. Advanced glaucoma or intraocular pressure above 22 mm Hg in the study eye despitetreatment.

Study Design

Total Participants: 338
Study Start date:
August 01, 2007
Estimated Completion Date:
May 31, 2009

Connect with a study center

  • Calgary Retina Consultants (site 318)

    Calgary, Alberta T3E 7M8
    Canada

    Site Not Available

  • Ivey Eye Institute (site 314)

    London, Ontario N6A 4G5
    Canada

    Site Not Available

  • Canadian Centre for Advanced Eye Therapeutics (site 291)

    Mississauga, Ontario L4W 1W9
    Canada

    Site Not Available

  • Sunnybrook Health Sciences Centre (site 305)

    Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • Eye Centre Pasqua Hospital (site 299)

    Regina, Saskatchewan S4T 1A5
    Canada

    Site Not Available

  • Associated Retina Consultants (site 286)

    Phoenix, Arizona 85020
    United States

    Site Not Available

  • Retinal Consultants of Arizona (site 209)

    Phoenix, Arizona 85014
    United States

    Site Not Available

  • Retina Centers PC (site 215)

    Tucson, Arizona 85704
    United States

    Site Not Available

  • Eye Medical Center (site 287)

    Fresno, California 93720
    United States

    Site Not Available

  • Northern California Retina Vitreous Associates (site 320)

    Mountain View, California 94040
    United States

    Site Not Available

  • Retina Institute of California (site 207)

    Pasadena, California 91105
    United States

    Site Not Available

  • Retina Consultants San Diego (site 232)

    Poway, California 93064
    United States

    Site Not Available

  • Retinal Consultants Medical Group (site 289)

    Sacramento, California 95819
    United States

    Site Not Available

  • Orange County Retina Medical Group (site 252)

    Santa Ana, California 92705
    United States

    Site Not Available

  • Miramar Eye Specialists Medical Group (site 245)

    Ventura, California 93003
    United States

    Site Not Available

  • The Eye Care Group, PC (site 315)

    Waterbury, Connecticut 06708
    United States

    Site Not Available

  • Florida Eye Clinic (site 257)

    Altamonte Springs, Florida 32701
    United States

    Site Not Available

  • Florida Eye Microsurgical Institute, Inc. (site 217)

    Boynton Beach, Florida 33426
    United States

    Site Not Available

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

    Fort Myers, Florida 33912
    United States

    Site Not Available

  • Retina Health Center (site 247)

    Fort Myers, Florida 33901
    United States

    Site Not Available

  • Magruder Eye Institute (site 264)

    Orlando, Florida 32803
    United States

    Site Not Available

  • Southern Vitreoretinal Associates, PL (site 309)

    Tallahassee, Florida 32308
    United States

    Site Not Available

  • University of South Florida Eye Institute (site 311)

    Tampa, Florida 33612
    United States

    Site Not Available

  • Center for Retina and Macular Disease (site 293)

    Winter Haven, Florida 33880
    United States

    Site Not Available

  • Southeast Retina Center (site 268)

    Augusta, Georgia 30909
    United States

    Site Not Available

  • Midwest Eye Institute (site 253)

    Indianapolis, Indiana 46280
    United States

    Site Not Available

  • Retina Associates, PA (site 295)

    Shawnee Mission, Kansas 66204
    United States

    Site Not Available

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

    Wichita, Kansas 67214
    United States

    Site Not Available

  • Eye Centers of Louisville (site 251)

    Louisville, Kentucky 40207
    United States

    Site Not Available

  • Retina Specialists (site 231)

    Towson, Maryland 21204
    United States

    Site Not Available

  • Retina Associates St. Louis (site 300)

    Florissant, Missouri 63031
    United States

    Site Not Available

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

    Kansas City, Missouri 64108
    United States

    Site Not Available

  • Retinal Consultants of Nevada (site 273)

    Las Vegas, Nevada 89144
    United States

    Site Not Available

  • Eyesight Ophthalmic Services, PA (site 290)

    Portsmouth, New Hampshire 03801
    United States

    Site Not Available

  • Delaware Valley Retina Associates (site 261)

    Lawrenceville, New Jersey 08648
    United States

    Site Not Available

  • Retina-Vitreous Consultants (site 216)

    Livingston, New Jersey 07039
    United States

    Site Not Available

  • Retina Associates of New Jersey (site 298)

    Teaneck, New Jersey 07666
    United States

    Site Not Available

  • Capital Region Retina (site 316)

    Albany, New York 12206
    United States

    Site Not Available

  • New York Eye & Ear Infirmary (site 272)

    New York, New York 10003
    United States

    Site Not Available

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

    New York, New York 10022
    United States

    Site Not Available

  • Carolina Eye Associates (site 308)

    Southern Pines, North Carolina 28387
    United States

    Site Not Available

  • Retina Associates of Cleveland (site 228)

    Beachwood, Ohio 44122
    United States

    Site Not Available

  • Cincinnati Eye Institute (site 285)

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • Retina Associates of Cleveland, Inc. (site 219)

    Lakewood, Ohio 44107
    United States

    Site Not Available

  • Retina-Vitreous Associates (site 266)

    Toledo, Ohio 43608
    United States

    Site Not Available

  • Retina and Vitreous Center of Southern Oregon (site 271)

    Ashland, Oregon 97520
    United States

    Site Not Available

  • Ophthalmology Associates of PA (site 297)

    Bala Cynwyd, Pennsylvania 19004
    United States

    Site Not Available

  • Palmetto Retina Center (site 275)

    West Columbia, South Carolina 29169
    United States

    Site Not Available

  • Black Hills Regional Eye Institute (site 202)

    Rapid City, South Dakota 57701
    United States

    Site Not Available

  • Southeastern Retina Associates, PC (Site 250)

    Knoxville, Tennessee 37909
    United States

    Site Not Available

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

    Abilene, Texas 79606
    United States

    Site Not Available

  • Austin Retina Associates (site 304)

    Austin, Texas 78705
    United States

    Site Not Available

  • Retina Research Center (site 204)

    Austin, Texas 78705
    United States

    Site Not Available

  • University of Texas Medical Branch- Galveston (site 301

    Galveston, Texas 77555
    United States

    Site Not Available

  • Houston Eye Associates (site 321)

    Houston, Texas 77025
    United States

    Site Not Available

  • Valley Retina Institue, PA (site 258)

    McAllen, Texas 78503
    United States

    Site Not Available

  • Eye Care Associates of East Texas (site 282)

    Tyler, Texas 75701
    United States

    Site Not Available

  • Rocky Mountain Retina Consultants (site 256)

    Salt Lake City, Utah 84107
    United States

    Site Not Available

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

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • University of Virginia- Ophthalmology Dept. (site 254)

    Charlottesville, Virginia 22908
    United States

    Site Not Available

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