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A 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 Neovascular Age Related Macular Degeneration (AMD)
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).
Details
| Lead sponsor | Ora Bio Ltd. |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | UNKNOWN |
| Enrolment | 96 |
| Start date | 2009-03 |
| Completion | 2010-06 |
Conditions
- Macular Degeneration
Interventions
- ORA102 and Avastin
- Avastin
Primary outcomes
- The incidence and severity of ocular adverse events, including retinal detachment, increase in IOP, cataract, tearing of the retina, decrease in vision, RPE atrophy, and vitreous hemorrhage, will be evaluated. — 32 weeks
Countries
Israel