Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Evaluate the safety, tolerability, and efficacy of OTX-TKI for intravitreal use in subjects with Neovascular Age-Related Macular Degeneration
Multicenter, double masked, randomized, parallel-group study to evaluate the safety, tolerability, and efficacy of OTX-TKI for intravitreal use in subjects with Neovascular Age-Related Macular Degeneration
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OTX-TKI | Active Comparator |
| |
| Aflibercept | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OTX-TKI/Sham | Drug | OTX-TKI is one dose so subsequent visits will be sham to maintain the mask |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | Incidence and severity of treatment emergent adverse events | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| BCVA changes | BCVA Changes from Baseline | Through study completion, an average of 1 year |
| Central subfield thickness changes | Central subfield thickness changes from baseline |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ocular Therapeutix | Bakersfield | California | 93309 | United States | ||
| Ocular Therapeutix |
Not provided
3:1
Not provided
Not provided
Not provided
| Aflibercept/Sham |
| Drug |
Aflibercept administered every 8 weeks |
|
|
| Through study completion, an average of 1 year |
| Rescue Therapy | Proportion of subjects receiving rescue therapy | Through study completion, an average of 1 year |
| Absence of Fluid | Proportion of subjects with absence of foveal fluid | Through study completion, an average of 1 year |
| Number of injections | Number of injections from baseline | Through study completion, an average of 1 year |
| Oxnard |
| California |
| 93036 |
| United States |
| Ocular Therapeutix | Altamonte Springs | Florida | 32701 | United States |
| Ocular Therapeutix | St. Petersburg | Florida | 33711 | United States |
| Ocular Therapeutix | Reno | Nevada | 89502 | United States |
| Ocular Therapeutix | The Woodlands | Texas | 77384 | United States |
| ID | Term |
|---|---|
| C533178 | aflibercept |
Not provided
Not provided
Not provided