Status:
COMPLETED
Study of PAN-90806 Eye Drops, Suspension for Neovascular AMD
Lead Sponsor:
PanOptica, Inc.
Conditions:
Neovascular Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE1
PHASE2
Brief Summary
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
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 eligi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2019
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT03479372
Start Date
April 26 2018
End Date
June 27 2019
Last Update
July 9 2019
Active Locations (18)
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1
Colorado Retina Associates
Golden, Colorado, United States, 80401
2
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States, 21740
3
Retinal Consultants of Nevada
Henderson, Nevada, United States, 89052
4
Retinal Consultants of Nevada
Las Vegas, Nevada, United States, 89144