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)

Ora Bio

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Macular Degeneration

Treatments

Drug: ORA102 and Avastin

Drug: Avastin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00745511

OB-DAMD-01

Details and patient eligibility

About

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).

Enrollment

96 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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