Study of Topical Ocular PAN-90806 in PDR
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)
1 other identifier
interventional
10
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2015
2 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
June 13, 2015
CompletedFirst Posted
Study publicly available on registry
June 18, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedSeptember 28, 2016
September 1, 2016
9 months
June 13, 2015
September 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Patients with Adverse Events
Safety will be assessed based upon the incidence of all adverse events, ocular and systemic
2 months
Secondary Outcomes (4)
The mean change in best-corrected visual acuity from baseline
Week 8
Change in preretinal neovascularization
Week 4 and Week 8
The mean number of rescue treatments during the study
Week 8
Time to first rescue treatment
up to Week 8
Study Arms (1)
PAN-90806 Ophthalmic Solution
EXPERIMENTALPAN-90806 Ophthalmic Solution taken daily for 8 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PanOptica, Inc.lead
Study Sites (2)
Valley Retina Institute
Harlingen, Texas, 78550, United States
Valley Retina Institute
McAllen, Texas, 78503, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Victor H Gonzalez, M.D.
Valley Retina Institute
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2015
First Posted
June 18, 2015
Study Start
August 1, 2015
Primary Completion
May 1, 2016
Study Completion
July 1, 2016
Last Updated
September 28, 2016
Record last verified: 2016-09