Study of Topical Ocular PAN-90806 in PDR

NCT ID: NCT02475109

Last Updated: 2016-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-07-31

Brief Summary

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

Detailed Description

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Conditions

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Diabetic Retinopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PAN-90806 Ophthalmic Solution

PAN-90806 Ophthalmic Solution taken daily for 8 weeks.

Group Type EXPERIMENTAL

PAN-90806 Ophthalmic Solution

Intervention Type DRUG

Interventions

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PAN-90806 Ophthalmic Solution

Intervention Type DRUG

Other Intervention Names

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PAN-90806 Eye Drops

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PanOptica, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Victor H Gonzalez, M.D.

Role: PRINCIPAL_INVESTIGATOR

Valley Retina Institute

Locations

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Valley Retina Institute

Harlingen, Texas, United States

Site Status

Valley Retina Institute

McAllen, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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PAN-01-201

Identifier Type: -

Identifier Source: org_study_id

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