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

OPKO Health

Status and phase: Terminated; Phase 3

Conditions: Macular Degeneration

Treatments: Drug: bevasiranib; Drug: ranibizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00499590

ACU301

Details and patient eligibility

About

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.

Enrollment: 338 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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338 participants in 3 patient groups

A

Active Comparator group

Description:

Lucentis® (0.5mg) every 4 weeks.

Treatment:

Drug: ranibizumab

B

Experimental group

Description:

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.

Treatment:

Drug: bevasiranib

C

Experimental group

Description:

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.

Treatment:

Drug: bevasiranib