Phase 1 Study of Topical Ocular PAN-90806 for Neovascular AMD

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02022540
• Other study ID #: PAN-01-101
• 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

• Age-Related Macular Degeneration (AMD)
• Macular Degeneration
• Wet Macular Degeneration

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