Pilot Study to Evaluate the Safety and Efficacy of Treatment With ORA102 Combined With Avastin (Bevacizumab) Versus Avastin Alone, in Patients With Neovascular Age Related Macular Degeneration (AMD)

• Status: Unknown status
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is s randomized, multi-center, double blind, 3 arm, phase I/II pilot study to evaluate the safety and efficacy of treatment with ORA102 combined with Avastin (Bevacizumab) versus Avastin alone, in patients with neo-vascular age related macular degeneration (AMD).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ora Bio Ltd.
• Treatments: Bevacizumab

Criteria

Inclusion Criteria:

• Subjects who have provided informed consent, including signing of the informed consent form

• Subject who are able and willing to comply with the study protocol

• Subject must have best corrected visual acuity ETDRS between 20/40 to 20/320 in the study eye

• Subjects whose CNV lesion in the study eye contains more than 25% scarring and/or atrophy

• Women must be post-menopausal 1 year or surgically sterilized. If not, negative serum pregnancy test required within 14 days of randomization

Exclusion Criteria:

• Pregnant or lactating women

• Patients with severe myocardial disease or coronary occlusion

• Patients with severe personality disorder, suicidal risk or psychosis

• Patients with previous history of CVA

• Evidence for liver dysfunction - bilirubin level more than twice than upper limit of the normal value OR ALT/AST>1.5x upper limit of normal value

• Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contra-indicates the use of the investigational drugs or puts the patients in high risk for treatment related complications