Phase 1 Study of Topical Ocular PAN-90806 for Neovascular AMD
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)
1 other identifier
interventional
50
1 country
22
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2014
Typical duration for phase_1
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2013
CompletedFirst Posted
Study publicly available on registry
December 27, 2013
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedSeptember 28, 2016
September 1, 2016
2.1 years
December 20, 2013
September 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety
Presence of any targeted adverse events (TAEs); safety endpoints include adverse events, vital signs, laboratory abnormalities, ophthalmic findings and outcomes
3 months
Study Arms (6)
Stage 1 - Group 1
EXPERIMENTALPatients randomized to Group 1 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.
Stage 1 - Group 2
EXPERIMENTALPatients randomized to Group 2 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.
Stage 1- Group 3
EXPERIMENTALPatients randomized to Group 3 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.
Stage 1- Group 4
EXPERIMENTALPatients randomized to Group 4 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.
Stage 1 - Group 5
EXPERIMENTALPatients randomized to Group 5 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.
Stage 2
EXPERIMENTALPatients 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PanOptica, Inc.lead
Study Sites (22)
Unknown Facility
Colorado Springs, Colorado, United States
Unknown Facility
Winter Haven, Florida, United States
Unknown Facility
Shawnee Mission, Kansas, United States
Unknown Facility
Wichita, Kansas, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Portsmouth, New Hampshire, United States
Unknown Facility
Bloomfield, New Jersey, United States
Unknown Facility
Charlotte, North Carolina, United States
Unknown Facility
Durham, North Carolina, United States
Unknown Facility
Statesville, North Carolina, United States
Unknown Facility
Ashland, Oregon, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
West Columbia, South Carolina, United States
Unknown Facility
Rapid City, South Dakota, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
Abilene, Texas, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
Harlingen, Texas, United States
Unknown Facility
McAllen, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Willow Park, Texas, United States
Unknown Facility
Madison, Wisconsin, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Martin Wax, M.D.
PanOptica, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2013
First Posted
December 27, 2013
Study Start
February 1, 2014
Primary Completion
March 1, 2016
Study Completion
May 1, 2016
Last Updated
September 28, 2016
Record last verified: 2016-09