Phase 1 Study of Topical Ocular PAN-90806 for Neovascular AMD

Study Overview
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Brief Summary
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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).

Official Title
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A Phase I Open-Label, Multi-Center Trial With Randomization to Dose to Evaluate the Safety and Tolerability of Topical Ocular PAN-90806 in Patients With Neovascular Age-Related Macular Degeneration (AMD)

Conditions
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Age-Related Macular Degeneration (AMD)

Intervention / Treatment
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* Drug: PAN-90806 Ophthalmic Solution
* Drug: Lucentis


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: 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: aphakia diabetic macular edema any ocular inflammation or infections pathological myopia retinal detachment advanced glaucoma 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 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stage 1 - Group 1<br>Patients randomized to Group 1 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks. | Drug: PAN-90806 Ophthalmic Solution<br> <br> * Other names: PAN-90806 Eye Drops;|
| Experimental: Stage 1 - Group 2<br>Patients randomized to Group 2 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks. | Drug: PAN-90806 Ophthalmic Solution<br> <br> * Other names: PAN-90806 Eye Drops;|
| Experimental: Stage 1- Group 3<br>Patients randomized to Group 3 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks. | Drug: PAN-90806 Ophthalmic Solution<br> <br> * Other names: PAN-90806 Eye Drops;|
| Experimental: Stage 1- Group 4<br>Patients randomized to Group 4 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks. | Drug: PAN-90806 Ophthalmic Solution<br> <br> * Other names: PAN-90806 Eye Drops;|
| Experimental: Stage 1 - Group 5<br>Patients randomized to Group 5 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks. | Drug: PAN-90806 Ophthalmic Solution<br> <br> * Other names: PAN-90806 Eye Drops;|
| Experimental: Stage 2<br>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 | Drug: PAN-90806 Ophthalmic Solution<br> <br> * Other names: PAN-90806 Eye Drops;Drug: Lucentis<br> <br> * Other names: ranibizumab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neovascular Age-Related Macular Degeneration, AMD, Macular Degeneration, Age-Related Macular Degeneration, wet AMD, neovascular AMD, exudative AMD