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The objective of this study is to assess the safety and tolerability of topical ocular PAN-90806 in patients with active, subfoveal choroidal neovascularization associated with neovascular Age-Related Macular Degeneration (AMD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage 1 - Group 1 | Experimental | Patients randomized to Group 1 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks. |
|
| Stage 1 - Group 2 | Experimental | Patients randomized to Group 2 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks. |
|
| Stage 1- Group 3 | Experimental | Patients randomized to Group 3 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks. |
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| Stage 1- Group 4 | Experimental | Patients randomized to Group 4 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks. |
|
| Stage 1 - Group 5 | Experimental | Patients randomized to Group 5 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks. |
|
| Stage 2 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PAN-90806 Ophthalmic Solution | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Presence of any targeted adverse events (TAEs); safety endpoints include adverse events, vital signs, laboratory abnormalities, ophthalmic findings and outcomes | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
No prior ocular or systemic treatment or surgery for neovascular AMD in the study eye
History of or current clinical evidence in the study eye of:
History or evidence of the following surgeries in the study eye:
Uncontrolled hypertension despite use of antihypertensive medications
Participation in any investigational drug or device study, systemic or ocular, within past 3 months
Women who are pregnant or nursing
Known serious allergies or hypersensitivity to the fluorescein dye used in angiography or to the components of the PAN-90806 formulation
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| Name | Affiliation | Role |
|---|---|---|
| Martin Wax, M.D. | PanOptica, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado Springs | Colorado | United States | ||||
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Patients enrolled in Stage 2 will receive an intravitreal injection of ranibizumab and then 7-9 days later begin daily dosing with PAN-90806 Ophthalmic Solution for 12 weeks |
|
| Lucentis | Drug |
|
|
| Winter Haven |
| Florida |
| United States |
| Shawnee Mission | Kansas | United States |
| Wichita | Kansas | United States |
| Boston | Massachusetts | United States |
| Portsmouth | New Hampshire | United States |
| Bloomfield | New Jersey | United States |
| Charlotte | North Carolina | United States |
| Durham | North Carolina | United States |
| Statesville | North Carolina | United States |
| Ashland | Oregon | United States |
| Philadelphia | Pennsylvania | United States |
| West Columbia | South Carolina | United States |
| Rapid City | South Dakota | United States |
| Nashville | Tennessee | United States |
| Abilene | Texas | United States |
| Austin | Texas | United States |
| Harlingen | Texas | United States |
| McAllen | Texas | United States |
| San Antonio | Texas | United States |
| Willow Park | Texas | United States |
| Madison | Wisconsin | United States |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| 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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