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Double-masked, uncontrolled, multi-center, study in which participants will be randomized to one of 3 doses of topical ocular PAN 90806 administered once daily for 12 weeks.
Patients with newly diagnosed, active, pathologic CNV associated with neovascular AMD will be screened for inclusion into the study after providing written informed consent. Participants who are eligible for the study will be centrally randomized at Day 1 to one of three doses of PAN-90806 Eye Drops. Participants will be instructed to apply one drop of PAN-90806 to the ocular surface of the identified study eye once daily for twelve (12) weeks.
Participants will return for follow-up visits at Week 2, Week 4, Week 8, Week 12, 1 week after stopping PAN-90806 treatment and 1 month after stopping PAN-90806 treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PAN-90806 Eye Drops, dose 1 | Experimental | PAN-90806 Ophthalmic Suspension taken once daily for 12 weeks |
|
| PAN-90806 Eye Drops, dose 2 | Experimental | PAN-90806 Ophthalmic Suspension taken once daily for 12 weeks |
|
| PAN-90806 Eye Drops, dose 3 | Experimental | PAN-90806 Ophthalmic Suspension taken once daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PAN-90806 Ophthalmic Suspension | Drug | PAN-90806 provided in single-use dropper bottles for topical ocular administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events | up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in study eye ETDRS Visual Acuity | through Week 12 | |
| Mean change from baseline in study eye retinal thickness | through Week 12 | |
| Number of patients needing additional treatment with ranibizumab |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Wax, MD | PanOptica, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado Retina Associates | Golden | Colorado | 80401 | United States | ||
| Cumberland Valley Retina Consultants |
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Masking will be maintained by using a coded drug supply.
|
| through Week 12 |
| Hagerstown |
| Maryland |
| 21740 |
| United States |
| Retinal Consultants of Nevada | Henderson | Nevada | 89052 | United States |
| Retinal Consultants of Nevada | Las Vegas | Nevada | 89144 | United States |
| Retina Center of New Jersey | Bloomfield | New Jersey | 07003 | United States |
| Retina Center of New Jersey | Teaneck | New Jersey | 07666 | United States |
| Vision Research Center | Albuquerque | New Mexico | 87109 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Fakultní nemocnice Královské Vinohrady | Prague | 100 34 | Czechia |
| Axon Clinical | Prague | 150 00 | Czechia |
| Semmelweis University | Budapest | 1085 | Hungary |
| University of Debrecen | Debrecen | 4032 | Hungary |
| P. Stradina Clinical University hospital | Riga | LV1002 | Latvia |
| Barnet Hospital | Barnet | Hertfordshire | EN5 3DJ | United Kingdom |
| New Cross Hospital | Wolverhampton | West Midlands | WV10 0QP | United Kingdom |
| Bradford Royal Infirmary | Bradford | BD9 6RJ | United Kingdom |
| Moorefields Eye Hospital | London | EC1V 2PD | United Kingdom |
| Manchester Royal Eye Hospital | Manchester | M13 9WL | United Kingdom |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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