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

PanOptica

Status and phase: Completed; Phase 2; Phase 1

Conditions: Neovascular Age-related Macular Degeneration

Treatments: Drug: PAN-90806 Ophthalmic Suspension

Study type: Interventional

Funder types: Industry

Identifiers

NCT03479372

PAN-01-102

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 51 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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51 participants in 3 patient groups

PAN-90806 Eye Drops, dose 1

Experimental group

Description:

PAN-90806 Ophthalmic Suspension taken once daily for 12 weeks

Treatment:

Drug: PAN-90806 Ophthalmic Suspension

PAN-90806 Eye Drops, dose 2

Experimental group

Description:

PAN-90806 Ophthalmic Suspension taken once daily for 12 weeks

Treatment:

Drug: PAN-90806 Ophthalmic Suspension

PAN-90806 Eye Drops, dose 3

Experimental group

Description:

PAN-90806 Ophthalmic Suspension taken once daily for 12 weeks

Treatment:

Drug: PAN-90806 Ophthalmic Suspension