Back to resultsPhase 1 Study of Topical Ocular PAN-90806 for Neovascular AMD
Primary Purpose
Age-Related Macular Degeneration (AMD)
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PAN-90806 Ophthalmic Solution
Lucentis
Sponsored by
About this trial
This is an interventional treatment trial for Age-Related Macular Degeneration (AMD) focused on measuring Neovascular Age-Related Macular Degeneration, AMD, Macular Degeneration, Age-Related Macular Degeneration, wet AMD, neovascular AMD, exudative AMD
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Stage 1 - Group 1
Stage 1 - Group 2
Stage 1- Group 3
Stage 1- Group 4
Stage 1 - Group 5
Stage 2
Arm Description
Patients randomized to Group 1 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.
Patients randomized to Group 2 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.
Patients randomized to Group 3 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.
Patients randomized to Group 4 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.
Patients randomized to Group 5 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.
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
Outcomes
Primary Outcome Measures
Safety
Presence of any targeted adverse events (TAEs); safety endpoints include adverse events, vital signs, laboratory abnormalities, ophthalmic findings and outcomes
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02022540
Brief Title
Phase 1 Study of Topical Ocular PAN-90806 for Neovascular AMD
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 Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PanOptica, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration (AMD)
Keywords
Neovascular Age-Related Macular Degeneration, AMD, Macular Degeneration, Age-Related Macular Degeneration, wet AMD, neovascular AMD, exudative AMD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stage 1 - Group 1
Arm Type
Experimental
Arm Description
Patients randomized to Group 1 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.
Arm Title
Stage 1 - Group 2
Arm Type
Experimental
Arm Description
Patients randomized to Group 2 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.
Arm Title
Stage 1- Group 3
Arm Type
Experimental
Arm Description
Patients randomized to Group 3 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.
Arm Title
Stage 1- Group 4
Arm Type
Experimental
Arm Description
Patients randomized to Group 4 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.
Arm Title
Stage 1 - Group 5
Arm Type
Experimental
Arm Description
Patients randomized to Group 5 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.
Arm Title
Stage 2
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
PAN-90806 Ophthalmic Solution
Other Intervention Name(s)
PAN-90806 Eye Drops
Intervention Type
Drug
Intervention Name(s)
Lucentis
Other Intervention Name(s)
ranibizumab
Primary Outcome Measure Information:
Title
Safety
Description
Presence of any targeted adverse events (TAEs); safety endpoints include adverse events, vital signs, laboratory abnormalities, ophthalmic findings and outcomes
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Wax, M.D.
Organizational Affiliation
PanOptica, Inc.
Official's Role
Study Director
Facility Information:
City
Colorado Springs
State/Province
Colorado
Country
United States
City
Winter Haven
State/Province
Florida
Country
United States
City
Shawnee Mission
State/Province
Kansas
Country
United States
City
Wichita
State/Province
Kansas
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Portsmouth
State/Province
New Hampshire
Country
United States
City
Bloomfield
State/Province
New Jersey
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Durham
State/Province
North Carolina
Country
United States
City
Statesville
State/Province
North Carolina
Country
United States
City
Ashland
State/Province
Oregon
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
West Columbia
State/Province
South Carolina
Country
United States
City
Rapid City
State/Province
South Dakota
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Abilene
State/Province
Texas
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Harlingen
State/Province
Texas
Country
United States
City
McAllen
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Willow Park
State/Province
Texas
Country
United States
City
Madison
State/Province
Wisconsin
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Phase 1 Study of Topical Ocular PAN-90806 for Neovascular AMD
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