Clinical trial NCT03479372: Study of PAN-90806 Eye Drops, Suspension for Neovascular AMD
Official title: A Randomized, Double Masked, Uncontrolled , Multicenter Phase I/II Study to Evaluate Safety and Tolerability of PAN-90806 Eye Drops, Suspension in Treatment-Naïve Participants With Neovascular Age-Related Macular Degeneration (AMD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Neovascular Age-related Macular Degeneration
Keywords: AMD
wet AMD
exudative AMD
macular degeneration
Lead sponsor: PanOptica, Inc.
Sponsor class: INDUSTRY
First posted: 2018-03-27
Enrollment: 51
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with treatment-related adverse events
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Mean change from baseline in study eye ETDRS Visual Acuity
timeFrame: through Week 12
measure: Mean change from baseline in study eye retinal thickness
timeFrame: through Week 12
measure: Number of patients needing additional treatment with ranibizumab
timeFrame: through Week 12
Other outcomes:
Locations:
city: Golden
country: United States
facility: Colorado Retina Associates
state: Colorado
city: Hagerstown
country: United States
facility: Cumberland Valley Retina Consultants
state: Maryland
city: Henderson
country: United States
facility: Retinal Consultants of Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Retinal Consultants of Nevada
state: Nevada
city: Bloomfield
country: United States
facility: Retina Center of New Jersey
state: New Jersey
city: Teaneck
country: United States
facility: Retina Center of New Jersey
state: New Jersey
city: Albuquerque
country: United States
facility: Vision Research Center
state: New Mexico
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Praha
country: Czechia
facility: Fakultní nemocnice Královské Vinohrady
city: Praha
country: Czechia
facility: Axon Clinical
city: Budapest
country: Hungary
facility: Semmelweis University
city: Debrecen
country: Hungary
facility: University of Debrecen
city: Riga
country: Latvia
facility: P. Stradina Clinical University hospital
city: Barnet
country: United Kingdom
facility: Barnet Hospital
state: Hertfordshire
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
state: West Midlands
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary
city: London
country: United Kingdom
facility: Moorefields Eye Hospital
city: Manchester
country: United Kingdom
facility: Manchester Royal Eye Hospital
Study officials:
affiliation: PanOptica, Inc.
name: Martin Wax, MD
role: STUDY_DIRECTOR
References: