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

NCT ID: NCT03479372

Last Updated: 2019-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-26

Study Completion Date

2019-06-27

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.

Conditions

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Neovascular Age-related Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Masking will be maintained by using a coded drug supply.

Study Groups

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PAN-90806 Eye Drops, dose 1

PAN-90806 Ophthalmic Suspension taken once daily for 12 weeks

Group Type EXPERIMENTAL

PAN-90806 Ophthalmic Suspension

Intervention Type DRUG

PAN-90806 provided in single-use dropper bottles for topical ocular administration

PAN-90806 Eye Drops, dose 2

PAN-90806 Ophthalmic Suspension taken once daily for 12 weeks

Group Type EXPERIMENTAL

PAN-90806 Ophthalmic Suspension

Intervention Type DRUG

PAN-90806 provided in single-use dropper bottles for topical ocular administration

PAN-90806 Eye Drops, dose 3

PAN-90806 Ophthalmic Suspension taken once daily for 12 weeks

Group Type EXPERIMENTAL

PAN-90806 Ophthalmic Suspension

Intervention Type DRUG

PAN-90806 provided in single-use dropper bottles for topical ocular administration

Interventions

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PAN-90806 Ophthalmic Suspension

PAN-90806 provided in single-use dropper bottles for topical ocular administration

Intervention Type DRUG

Other Intervention Names

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PAN-90806 Eye Drops

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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PanOptica, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin Wax, MD

Role: STUDY_DIRECTOR

PanOptica, Inc.

Locations

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Colorado Retina Associates

Golden, Colorado, United States

Site Status

Cumberland Valley Retina Consultants

Hagerstown, Maryland, United States

Site Status

Retinal Consultants of Nevada

Henderson, Nevada, United States

Site Status

Retinal Consultants of Nevada

Las Vegas, Nevada, United States

Site Status

Retina Center of New Jersey

Bloomfield, New Jersey, United States

Site Status

Retina Center of New Jersey

Teaneck, New Jersey, United States

Site Status

Vision Research Center

Albuquerque, New Mexico, United States

Site Status

Duke University

Durham, North Carolina, United States

Site Status

Fakultní nemocnice Královské Vinohrady

Prague, , Czechia

Site Status

Axon Clinical

Prague, , Czechia

Site Status

Semmelweis University

Budapest, , Hungary

Site Status

University of Debrecen

Debrecen, , Hungary

Site Status

P. Stradina Clinical University hospital

Riga, , Latvia

Site Status

Barnet Hospital

Barnet, Hertfordshire, United Kingdom

Site Status

New Cross Hospital

Wolverhampton, West Midlands, United Kingdom

Site Status

Bradford Royal Infirmary

Bradford, , United Kingdom

Site Status

Moorefields Eye Hospital

London, , United Kingdom

Site Status

Manchester Royal Eye Hospital

Manchester, , United Kingdom

Site Status

Countries

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United States Czechia Hungary Latvia United Kingdom

Other Identifiers

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PAN-01-102

Identifier Type: -

Identifier Source: org_study_id

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