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

Phase 3

Terminated

• Conditions: Macular Degeneration
• Interventions: Drug: bevasiranib; Drug: ranibizumab

• Registration Number: NCT00499590
• Lead Sponsor: OPKO Health, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-07-10
• Study First Submitted QC: 2007-07-10
• Study First Posted: 2007-07-11
• Study Start: 2007-08
• Primary Completion: 2009-03
• Study Completion: 2009-05
• Status Verified: 2014-09
• Results First Submitted: 2014-09-25
• Results First Submitted QC: 2014-09-29
• Last Update Submitted: 2014-09-29
• Results First Posted: 2014-10-06
• Last Update Posted: 2014-10-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 338

Inclusion Criteria

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

Exclusion Criteria

1. 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)
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 despite treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C	bevasiranib	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.
A	ranibizumab	Lucentis® (0.5mg) every 4 weeks.
B	bevasiranib	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.

Primary Outcome Measures

Name	Time	Method
Visual Acuity	week 60	avoidance of 3 or more lines of vision loss

Secondary Outcome Measures

Name	Time	Method
Need for Rescue Therapy, Time to Rescue Therapy, and Number of Patients With a 3 or More Line Gain in Vision	Week 60

Trial Locations

Locations (60)

Retinal Consultants of Arizona (site 209); 🇺🇸 Phoenix, Arizona, United States

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

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