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

• Status: Withdrawn
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the safety and effectiveness of three doses of intravitreal bevasiranib sodium as maintenance therapy for Age-Related Macular Degeneration following initiation of anti-VEGF therapy with three doses of Lucentis®.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OPKO Health, Inc.
• Treatments: Ranibizumab

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.