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

Stopped early · Phase 3

Conditions studied: Macular Degeneration

In brief

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.

Key facts

Study ID

NCT00499590

Run by

OPKO Health, Inc.

People needed

338

Starts

2007-08-01

Expected to finish

2009-05-01

Last updated by the study team

2014-10-06

Who can join

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

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.

Where it is running

• Associated Retina Consultants (site 286) — Phoenix, Arizona, United States
• Retina Centers PC (site 215) — Tucson, Arizona, United States
• Eye Medical Center (site 287) — Fresno, California, United States
• Northern California Retina Vitreous Associates (site 320) — Mountain View, California, United States
• Retina Institute of California (site 207) — Pasadena, California, United States
• Retina Consultants San Diego (site 232) — Poway, California, United States
• Retinal Consultants Medical Group (site 289) — Sacramento, California, United States
• Orange County Retina Medical Group (site 252) — Santa Ana, California, United States
• Miramar Eye Specialists Medical Group (site 245) — Ventura, California, United States
• The Eye Care Group, PC (site 315) — Waterbury, Connecticut, United States
• Florida Eye Clinic (site 257) — Altamonte Springs, Florida, United States
• Florida Eye Microsurgical Institute, Inc. (site 217) — Boynton Beach, Florida, United States
• Retina Health Center (site 247) — Fort Myers, Florida, United States
• National Ophthalmic Research Institute at Retina Consultants of SW Florida (site 270) — Fort Myers, Florida, United States
• Magruder Eye Institute (site 264) — Orlando, Florida, United States
• Southern Vitreoretinal Associates, PL (site 309) — Tallahassee, Florida, United States
• University of South Florida Eye Institute (site 311) — Tampa, Florida, United States
• Center for Retina and Macular Disease (site 293) — Winter Haven, Florida, United States
• Southeast Retina Center (site 268) — Augusta, Georgia, United States
• Midwest Eye Institute (site 253) — Indianapolis, Indiana, United States
• Retina Associates, PA (site 295) — Shawnee Mission, Kansas, United States
• Vitreo-Retinal Consultants & Surgeons, P.A. (site 274) — Wichita, Kansas, United States
• Eye Centers of Louisville (site 251) — Louisville, Kentucky, United States
• Retina Specialists (site 231) — Towson, Maryland, United States
• Retinal Consultants of Arizona (site 209) — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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