Status:
UNKNOWN
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)
Lead Sponsor:
Ora Bio Ltd.
Conditions:
Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE1
PHASE2
Brief 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, i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2010
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00745511
Start Date
March 1 2009
End Date
June 1 2010
Last Update
June 9 2009
Active Locations (5)
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1
Barzilai Medical Center
Ashkelon, Israel
2
Carmel Medical Center
Haifa, Israel
3
Hadassah Medical center Israel
Jerusalem, Israel
4
Ziv Medical Center
Safed, Israel