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Retina Associates - Research Coordinators
 
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Study Detail: COBALT

Trial Description Summary : A 2 year study of bevasiranib sodium (study drug) that is injected every 8 or 12 weeks as maintenance therapy. This is done following 3 injections of Lucentis® (FDA approved drug that is the currently approved treatment) compared with Lucentis® monotherapy every 4 weeks in patients with Exudative Age-Related Macular Degeneration (also known as wet AMD or wet macular degeneration).

Basic Trial Information

Phase

Disease

Status

Age

Sponsor

Protocol #

Three

Exudative Age related macular degeneration (wet form)

Enrolling

50 or older

OpKO

ACU301

Study Duration: Two years

Eligibility Criteria:

Inclusion Criteria

· Subfoveal CNV (classic, minimally classic, or occult with no classic lesions) total lesion size including blood, scarring and NV <12 total disc areas (30.48mm)

· ETDRS of 69 to 24 letters (20/40 to 20/320) in the study eye

· Occult with no classic must have recent progression of disease: SRH or 1 line VA loss past 12 week or FA lesion growth by >10% in the past 12 weeks.

· Age 50 or older

· Other inclusion criteria per study coordinator

Exclusion Criteria

· Previous treatment in the study eye with ANY agent except vitamins and minerals

· Concomitant disease in the study eye, uveitis, RPE tears or rips, acute ocular or periocular infections.

· Advanced Glaucoma (C/D .0.8) IOP >22mmHgwith treatment

· Any retinal vasculopathies in the study eye

· Subfoveal Scarring, atrophy, or hemorrhage >500um in the study eye

· CNV more than 25% scarring and/or fibrosis

· CNV from other causes

· Intraocular surgery in study eye within 12 weeks prior to screening

· Extrafoveal/juxtafoveal laser in study eye within 2 weeks prior to screening

· Previous PPV

· Known allergies to FA not amenable to tx with diphenhydramine

· Radiation to head or neck

· Any investigational drug within 4 weeks prior to screening

· Intravitreal device or drug implant in the study eye

· Premenopausal women not using adequate contraception

· Other exclusion criteria per study coordinator

Study Title : OpKO COBALT "A Phase 3, randomized, double-masked, parallel-assignment study of intravitreal bevasiranib sodium, administered every 8 or 12 weeks as maintenance therapry following three injections of Lucentis® compared with Lucentis® monotherapy every 4 weeks in patients with Exudative Age-Related Macular Degenration (AMD)

Trial Contact Information

Site

Study Coordinator

Beachwood

Steph at 216/831-5704 ext. 6800

Lakewood

Susan at 216/831-5704 ext. 6800