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

Sponsor

PanOptica, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02022540

Collaborator

(none)

Enrollment

Locations

Arms

26.9

Duration (Months)

2.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Age-Related Macular Degeneration (AMD)	Drug: PAN-90806 Ophthalmic Solution Drug: Lucentis	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Feb 1, 2014

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stage 1 - Group 1 Patients randomized to Group 1 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.	Drug: PAN-90806 Ophthalmic Solution Other Names: PAN-90806 Eye Drops
Experimental: Stage 1 - Group 2 Patients randomized to Group 2 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.	Drug: PAN-90806 Ophthalmic Solution Other Names: PAN-90806 Eye Drops
Experimental: Stage 1- Group 3 Patients randomized to Group 3 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.	Drug: PAN-90806 Ophthalmic Solution Other Names: PAN-90806 Eye Drops
Experimental: Stage 1- Group 4 Patients randomized to Group 4 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.	Drug: PAN-90806 Ophthalmic Solution Other Names: PAN-90806 Eye Drops
Experimental: Stage 1 - Group 5 Patients randomized to Group 5 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.	Drug: PAN-90806 Ophthalmic Solution Other Names: PAN-90806 Eye Drops
Experimental: Stage 2 Patients enrolled in Stage 2 will receive an intravitreal injection of ranibizumab and then 7-9 days later begin daily dosing with PAN-90806 Ophthalmic Solution for 12 weeks	Drug: PAN-90806 Ophthalmic Solution Other Names: PAN-90806 Eye Drops Drug: Lucentis Other Names: ranibizumab

Outcome Measures

Primary Outcome Measures

Safety [3 months]
Presence of any targeted adverse events (TAEs); safety endpoints include adverse events, vital signs, laboratory abnormalities, ophthalmic findings and outcomes

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	City	State	Country
1	Colorado Springs	Colorado	United States
2	Winter Haven	Florida	United States
3	Shawnee Mission	Kansas	United States
4	Wichita	Kansas	United States
5	Boston	Massachusetts	United States
6	Portsmouth	New Hampshire	United States
7	Bloomfield	New Jersey	United States
8	Charlotte	North Carolina	United States
9	Durham	North Carolina	United States
10	Statesville	North Carolina	United States
11	Ashland	Oregon	United States
12	Philadelphia	Pennsylvania	United States
13	West Columbia	South Carolina	United States
14	Rapid City	South Dakota	United States
15	Nashville	Tennessee	United States
16	Abilene	Texas	United States
17	Austin	Texas	United States
18	Harlingen	Texas	United States
19	McAllen	Texas	United States
20	San Antonio	Texas	United States
21	Willow Park	Texas	United States
22	Madison	Wisconsin	United States