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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Active Comparator |
| |
| 3 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ORA102 and Avastin | Drug | treatment with intravitreal injections of Avastin 1.25mg (0.05ml)and ORA102 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Central Retinal thickness and presence of intra/sub-retinal fluid observed by OCT at week 32 | 32 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yossi Israeli | Contact | +972-26067006 | yos@orabio.com |
| Name | Affiliation | Role |
|---|---|---|
| Itay Chovers, MD | Hadassah Medical Organization | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barzilai Medical Center | Recruiting | Ashkelon | Israel | |||
| Carmel Medical Center |
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| Avastin | Drug | treatment with intravitreal injections of Avastin 1.25mg (0.05ml) |
|
| Recruiting |
| Haifa |
| Israel |
| Hadassah Medical center Israel | Recruiting | Jerusalem | Israel |
|
| Ziv Medical Center | Recruiting | Safed | Israel |
| Tel-Aviv Sourasky Medical Center | Recruiting | Tel Aviv | Israel |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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