Back to resultsStudy of Topical Ocular PAN-90806 in PDR
Primary Purpose
Diabetic Retinopathy
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PAN-90806 Ophthalmic Solution
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Retinopathy focused on measuring Proliferative Diabetic Retinopathy
Eligibility Criteria
Inclusion Criteria:
- Aged 18 years or older with type 1 or type 2 diabetes
- Proliferative diabetic retinopathy (PDR) in study eye retina with or without diabetic macular edema (DME) involving the center of the macula
- Demonstrate the ability, or have a family member who is willing and able, to instill topical ocular drops in the study eye
Exclusion Criteria:
- Current or recent use (within the last 3 months) of anti-vascular endothelial growth factors (anti-VEGF) in either eye;
- Uncontrolled hypertension despite use of antihypertensive medications
- Unwillingness to refrain from wearing contact lenses for the duration of the study.
- 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
- Valley Retina Institute
- Valley Retina Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PAN-90806 Ophthalmic Solution
Arm Description
PAN-90806 Ophthalmic Solution taken daily for 8 weeks.
Outcomes
Primary Outcome Measures
Number of Patients with Adverse Events
Safety will be assessed based upon the incidence of all adverse events, ocular and systemic
Secondary Outcome Measures
The mean change in best-corrected visual acuity from baseline
Change in preretinal neovascularization
descriptive observations of the presence and extent as determined by ultra-wide field fluorescein angiography (FA) and color fundus photography (FP)
The mean number of rescue treatments during the study
Time to first rescue treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02475109
Brief Title
Study of Topical Ocular PAN-90806 in PDR
Official Title
A Phase 1 Open-Label, Single-Center Study to Evaluate the Safety and Tolerability of Topical Ocular PAN-90806 in Patients With Proliferative Diabetic Retinopathy (PDR)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
July 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 proliferative diabetic retinopathy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy
Keywords
Proliferative Diabetic Retinopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PAN-90806 Ophthalmic Solution
Arm Type
Experimental
Arm Description
PAN-90806 Ophthalmic Solution taken daily for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
PAN-90806 Ophthalmic Solution
Other Intervention Name(s)
PAN-90806 Eye Drops
Primary Outcome Measure Information:
Title
Number of Patients with Adverse Events
Description
Safety will be assessed based upon the incidence of all adverse events, ocular and systemic
Time Frame
2 months
Secondary Outcome Measure Information:
Title
The mean change in best-corrected visual acuity from baseline
Time Frame
Week 8
Title
Change in preretinal neovascularization
Description
descriptive observations of the presence and extent as determined by ultra-wide field fluorescein angiography (FA) and color fundus photography (FP)
Time Frame
Week 4 and Week 8
Title
The mean number of rescue treatments during the study
Time Frame
Week 8
Title
Time to first rescue treatment
Time Frame
up to Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 18 years or older with type 1 or type 2 diabetes
Proliferative diabetic retinopathy (PDR) in study eye retina with or without diabetic macular edema (DME) involving the center of the macula
Demonstrate the ability, or have a family member who is willing and able, to instill topical ocular drops in the study eye
Exclusion Criteria:
Current or recent use (within the last 3 months) of anti-vascular endothelial growth factors (anti-VEGF) in either eye;
Uncontrolled hypertension despite use of antihypertensive medications
Unwillingness to refrain from wearing contact lenses for the duration of the study.
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
Victor H Gonzalez, M.D.
Organizational Affiliation
Valley Retina Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Valley Retina Institute
City
Harlingen
State/Province
Texas
ZIP/Postal Code
78550
Country
United States
Facility Name
Valley Retina Institute
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Study of Topical Ocular PAN-90806 in PDR
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