Study of Topical Ocular PAN-90806 in PDR

September 27, 2016 updated by: PanOptica, Inc.

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)

The objective of this study is to assess the safety and tolerability of topical ocular PAN-90806 in patients with proliferative diabetic retinopathy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Harlingen, Texas, United States, 78550
        • Valley Retina Institute
      • McAllen, Texas, United States, 78503
        • Valley Retina Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PAN-90806 Ophthalmic Solution
PAN-90806 Ophthalmic Solution taken daily for 8 weeks.
Drug: PAN-90806 Ophthalmic Solution
Other Names:
  • PAN-90806 Eye Drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients with Adverse Events
Time Frame: 2 months
Safety will be assessed based upon the incidence of all adverse events, ocular and systemic
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The mean change in best-corrected visual acuity from baseline
Time Frame: Week 8
Week 8
Change in preretinal neovascularization
Time Frame: Week 4 and Week 8
descriptive observations of the presence and extent as determined by ultra-wide field fluorescein angiography (FA) and color fundus photography (FP)
Week 4 and Week 8
The mean number of rescue treatments during the study
Time Frame: Week 8
Week 8
Time to first rescue treatment
Time Frame: up to Week 8
up to Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PanOptica, Inc.

Investigators

  • Principal Investigator: Victor H Gonzalez, M.D., Valley Retina Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

June 13, 2015

First Submitted That Met QC Criteria

June 17, 2015

First Posted (Estimate)

June 18, 2015

Study Record Updates

Last Update Posted (Estimate)

September 28, 2016

Last Update Submitted That Met QC Criteria

September 27, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAN-01-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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