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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02022540
Other study ID # PAN-01-101
Secondary ID
Status Completed
Phase Phase 1
First received December 20, 2013
Last updated September 27, 2016
Start date February 2014
Est. completion date May 2016

Study information

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

Clinical Trial 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).


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
PAN-90806 Ophthalmic Solution

Lucentis


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
PanOptica, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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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