Clinical trial NCT02022540: Phase 1 Study of Topical Ocular PAN-90806 for Neovascular AMD
Official title: A Phase I Open-Label, Multi-Center Trial With Randomization to Dose to Evaluate the Safety and Tolerability of Topical Ocular PAN-90806 in Patients With Neovascular Age-Related Macular Degeneration (AMD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Age-Related Macular Degeneration (AMD)
Keywords: Neovascular Age-Related Macular Degeneration
AMD
Macular Degeneration
Age-Related Macular Degeneration
wet AMD
neovascular AMD
exudative AMD
Lead sponsor: PanOptica, Inc.
Sponsor class: INDUSTRY
First posted: 2013-12-27
Enrollment: 50
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: The objective of this study is to assess the safety and tolerability of topical ocular PAN-90806 in patients with active, subfoveal choroidal neovascularization associated with neovascular Age-Related Macular Degeneration (AMD).


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:

* No prior ocular or systemic treatment or surgery for neovascular AMD in the study eye
* 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
  * 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
* Known serious allergies or hypersensitivity to the fluorescein dye used in angiography or to the components of the PAN-90806 formulation

Primary outcomes:
measure: Safety
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Colorado Springs
country: United States
state: Colorado
city: Winter Haven
country: United States
state: Florida
city: Shawnee Mission
country: United States
state: Kansas
city: Wichita
country: United States
state: Kansas
city: Boston
country: United States
state: Massachusetts
city: Portsmouth
country: United States
state: New Hampshire
city: Bloomfield
country: United States
state: New Jersey
city: Charlotte
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Statesville
country: United States
state: North Carolina
city: Ashland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: West Columbia
country: United States
state: South Carolina
city: Rapid City
country: United States
state: South Dakota
city: Nashville
country: United States
state: Tennessee
city: Abilene
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Harlingen
country: United States
state: Texas
city: McAllen
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Willow Park
country: United States
state: Texas
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: PanOptica, Inc.
name: Martin Wax, M.D.
role: STUDY_DIRECTOR
References: