Study Detail: Novartis Geographic Atrophy (for dry macular degeneration)

Trial Description Summary 
A 14 month study consisting of 18 visits including12 intravitreal injections of an antibody that inhibits activation of Complement 5.  Patient have a 2 out 3 chance of receiving the medication while a 1 out of 3 chance of receiving a placebo (fake injection without injection in the eye).  There is transportation assistance.

Basic Trial Information
Phase I 
Disease: Dry Macular Degeneration- Geographic Atrophy
Status: Enrolling in December 2011 
Age: 55-90 
Sponsor: Novartis 
Protocol # CLFG316A2203 
Study Duration: 12 months 

Eligibility Criteria
Inclusion Criteria
• AMD in EITHER eye defined as drusen larger than 63µm or history of drusen if now obscured by advanced AMD.
• Geographic Atrophy must be approximately 1.3-6 DA in total size.
• May have CNV (wet AMD) in one eye but study eye cannot have CNV.
• Refracted vision of 20/60 or worse.

 Exclusion Criteria
• Any other retinal disease of the macula.
• Media opacities that would interfere with imaging.
• History of eye surgery in the study eye in the past 90 days, or the fellow eye within 30 days.
• History of infectious uveitis, herpes keratitis or endophthalmitis in either eye.
• Participation in any other clinical trials where there is an intervention.  (Vitamin studies or disease that only follow disease characteristics are allowed.)

Study Title
A multicenter, randomized, sham-control, proof-of-concept study of intravitreal LFG316 in patients with geographic atrophy associated with age-related macular degeneration. 

Trial Contact Information
Site: Beachwood 
Study Coordinator: 216/831-5700 x 253