Study of PAN-90806 Eye Drops, Suspension for Neovascular AMD
- Conditions
- Neovascular Age-related Macular Degeneration
- Interventions
- Drug: PAN-90806 Ophthalmic Suspension
- Registration Number
- NCT03479372
- Lead Sponsor
- PanOptica, Inc.
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PAN-90806 Eye Drops, dose 2 PAN-90806 Ophthalmic Suspension PAN-90806 Ophthalmic Suspension taken once daily for 12 weeks PAN-90806 Eye Drops, dose 3 PAN-90806 Ophthalmic Suspension PAN-90806 Ophthalmic Suspension taken once daily for 12 weeks PAN-90806 Eye Drops, dose 1 PAN-90806 Ophthalmic Suspension PAN-90806 Ophthalmic Suspension taken once daily for 12 weeks
- Primary Outcome Measures
Name Time Method Number of participants with treatment-related adverse events up to 12 weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (16)
Retinal Consultants of Nevada
🇺🇸Las Vegas, Nevada, United States
Duke University
🇺🇸Durham, North Carolina, United States
University of Debrecen
🇭🇺Debrecen, Hungary
Bradford Royal Infirmary
🇬🇧Bradford, United Kingdom
Moorefields Eye Hospital
🇬🇧London, United Kingdom
Cumberland Valley Retina Consultants
🇺🇸Hagerstown, Maryland, United States
Colorado Retina Associates
🇺🇸Golden, Colorado, United States
Vision Research Center
🇺🇸Albuquerque, New Mexico, United States
Retina Center of New Jersey
🇺🇸Teaneck, New Jersey, United States
Axon Clinical
🇨🇿Praha, Czechia
Fakultní nemocnice Královské Vinohrady
🇨🇿Praha, Czechia
Semmelweis University
🇭🇺Budapest, Hungary
P. Stradina Clinical University hospital
🇱🇻Riga, Latvia
Barnet Hospital
🇬🇧Barnet, Hertfordshire, United Kingdom
New Cross Hospital
🇬🇧Wolverhampton, West Midlands, United Kingdom
Manchester Royal Eye Hospital
🇬🇧Manchester, United Kingdom