Age-Related Macular Degeneration (AMD) Clinical Trial
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)
Verified date | September 2016 |
Source | PanOptica, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 50 |
Est. completion date | May 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 50 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
PanOptica, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety | Presence of any targeted adverse events (TAEs); safety endpoints include adverse events, vital signs, laboratory abnormalities, ophthalmic findings and outcomes | 3 months | Yes |
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