Phase 1 Study of Topical Ocular PAN-90806 for Neovascular AMD
Status: | Active, not recruiting |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 50 - Any |
Updated: | 4/21/2016 |
Start Date: | February 2014 |
End Date: | June 2016 |
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)
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).
PAN-90806 in patients with active, subfoveal choroidal neovascularization associated with
neovascular Age-Related Macular Degeneration (AMD).
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
We found this trial at
22
sites
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