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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
51
PAN-90806 provided in single-use dropper bottles for topical ocular administration
Colorado Retina Associates
Golden, Colorado, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States
Number of participants with treatment-related adverse events
Time frame: up to 12 weeks
Mean change from baseline in study eye ETDRS Visual Acuity
Time frame: through Week 12
Mean change from baseline in study eye retinal thickness
Time frame: through Week 12
Number of patients needing additional treatment with ranibizumab
Time frame: through Week 12
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