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| ID | Type | Description | Link |
|---|---|---|---|
| SOL-X | Other Identifier | Ocular Therapeutix, Inc. |
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| Name | Class |
|---|---|
| Fortrea | INDUSTRY |
| Duke Reading Center | UNKNOWN |
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Study to Evaluate Long-Term Safety of Intravitreal OTX-TKI (Axitinib Implant) in Participants with Neovascular Age-Related Macular Degeneration Who Successfully Completed 2-Year OTX-TKI-2023-AMD-301 or OTX-TKI-2023-AMD-303 Study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OTX-TKI | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OTX-TKI | Drug | Intravitreal Injection of OTX-TKI |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of treatment-emergent adverse events (TEAEs) from Baseline (Day 1) through Week 144 | Number of events | from Baseline (Day 1) through Week 144 |
| Proportion of participants with severe vision loss (defined as ≥ 30 Early Treatment Diabetic Retinopathy Study [ETDRS] letters loss) from Baseline (Day 1) through Week 144 | Percentage | from Baseline (Day 1) through Week 144 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | Contact | 781-357-4000 | clinicalaffairs@ocutx.com | |
| Nichole Wilkes | Contact | 770-375-1020 | nwilkes@ocutx.com |
| Name | Affiliation | Role |
|---|---|---|
| Dilsher Dhoot, MD | California Retina Consultants (CRC)-Bakersfield | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Retina Consultants (CRC) | Recruiting | Bakersfield | California | 93309 | United States |
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| California Retina Consultants (CRC) | Recruiting | Santa Barbara | California | 93103 | United States |
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| Retina Group of New England | Recruiting | Waterford | Connecticut | 06385 | United States |
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| Retina Group of Florida - Fort Lauderdale | Recruiting | Fort Lauderdale | Florida | 33308 | United States |
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| Cumberland Valley Retina Associates | Recruiting | Hagerstown | Maryland | 21740 | United States |
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| Mid Atlantic Retina Specialists | Recruiting | Hagerstown | Maryland | 21740 | United States |
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| Palmetto Retina Center | Recruiting | West Columbia | South Carolina | 29619 | United States |
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| Austin Retina Associates | Recruiting | Austin | Texas | 78705 | United States |
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