Study of PAN-90806 Eye Drops, Suspension for Neovascular AMD

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized, Double Masked, Uncontrolled , Multicenter Phase I/II Study to Evaluate Safety and Tolerability of PAN-90806 Eye Drops, Suspension in Treatment-Naïve Participants With Neovascular Age-Related Macular Degeneration (AMD)

Conditions
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Neovascular Age-related Macular Degeneration

Intervention / Treatment
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* Drug: PAN-90806 Ophthalmic Suspension


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis in the study eye of active, pathologic, newly diagnosed and previously untreated, subfoveal choroidal neovascular (CNV) lesions secondary to neovascular AMD Aged 50 years or older Demonstrate the ability, or have a family member who is willing and able, to instill topical ocular drops in the study eye Exclusion Criteria: Prior ocular or systemic treatment or surgery for neovascular AMD in the study eye Prior use within the last 3 months or a high possibility of requiring treatment with anti-VEGF therapy in the fellow eye during the study Significant retinal serous pigment epithelial detachment (PED), atrophy, or fibrosis/scar involving the fovea History of or current clinical evidence in the study eye of aphakia, diabetic macular edema, any ocular inflammation or infections, pathological myopia, retinal detachment, advanced glaucoma, and/or significant media opacity, including cataract History or evidence of the following surgeries in the study eye: penetrating keratoplasty or vitrectomy; corneal transplant; corneal or intraocular surgery within 3 months of Screening 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 Women of child-bearing potential who are not using a highly effective form of birth control Known serious allergies or hypersensitivity to the fluorescein dye used in angiography or to the components of the PAN-90806 formulation

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PAN-90806 Eye Drops, dose 1<br>PAN-90806 Ophthalmic Suspension taken once daily for 12 weeks | Drug: PAN-90806 Ophthalmic Suspension<br>* PAN-90806 provided in single-use dropper bottles for topical ocular administration<br>* Other names: PAN-90806 Eye Drops;|
| Experimental: PAN-90806 Eye Drops, dose 2<br>PAN-90806 Ophthalmic Suspension taken once daily for 12 weeks | Drug: PAN-90806 Ophthalmic Suspension<br>* PAN-90806 provided in single-use dropper bottles for topical ocular administration<br>* Other names: PAN-90806 Eye Drops;|
| Experimental: PAN-90806 Eye Drops, dose 3<br>PAN-90806 Ophthalmic Suspension taken once daily for 12 weeks | Drug: PAN-90806 Ophthalmic Suspension<br>* PAN-90806 provided in single-use dropper bottles for topical ocular administration<br>* Other names: PAN-90806 Eye Drops;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events |  | up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | through Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AMD, wet AMD, exudative AMD, macular degeneration