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To evaluate the safety, tolerability and efficacy of OTX-TKI for intravitreal use, in subjects who have neovascular age-related macular degeneration (AMD).
A multi-center, dose escalation, Phase 1, safety, tolerability and efficacy study to evaluate three dose groups of the OTX-TKI implant to treat subjects with a diagnosis of primary subfoveal neovascularization secondary to AMD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (Low Dose) | Experimental | Subjects will receive a low dose of OTX-TKI |
|
| Cohort 2 (Middle Dose) | Experimental | Subjects will receive a middle dose of OTX-TKI. |
|
| Cohort 3 (High Dose) | Experimental | Subjects will receive a high dose of OTX-TKI. |
|
| Cohort 3 (Anti-VEGF) | Experimental | Subjects will receive OTX-TKI plus a single anti-VEGF injection |
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| Cohort 4 (High Dose) | Experimental | Subjects will receive a high dose of OTX-TKI. |
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| Cohort 4 (Anti-VEGF) | Experimental | Subjects will receive OTX-TKI plus a single anti-VEGF injection |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OTX-TKI | Drug | OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment emergent adverse events for each subject | All adverse events from screening through end of study will be captured | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the Maximum Tolerated Dose of the OTX-TKI injection | A Central Reading Center will evaluate multiple imaging modalities to confirm evidence of biological activity for subjects that have been treated with the OTX-TKI injection. If all subjects tolerate lower dosages, additional subjects will be treated at higher dosages. All data will be evaluated by the DSMC who, in concert with the Medical Monitor, will determine the Maximally Tolerated Dose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ocular Therapeutix, Inc. | Sydney | Site 1 | Australia | |||
| Ocular Therapeutiux, Inc. |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
| D000068258 | Bevacizumab |
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| OTX-TKI | Drug | OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI). |
|
| OTX-TKI | Drug | OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI). |
|
| OTX-TKI | Drug | OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI). |
|
| Anti-VEGF | Drug | Standard of care therapy used to block vascular endothelial growth factor |
|
|
| OTX-TKI | Drug | OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI). |
|
| Anti-VEGF | Drug | Standard of care therapy used to block vascular endothelial growth factor |
|
|
| 9 months |
| Sydney |
| Site 2 |
| Australia |
| Ocular Therapeutiux, Inc. | Sydney | Site 3 | Australia |
| Ocular Therapeutix, Inc. | Adelaide | Australia |
| Ocular Therapeutix, Inc. | Albury | Australia |
| Ocular Therapeutix, Inc. | Melbourne | Australia |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |