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Completed

NCT Number: NCT02475109

Study of Topical Ocular PAN-90806 in PDR

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

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Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Retinal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Valley Retina Institute, Harlingen, Texas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PAN-90806 Ophthalmic Solution

Drug

Other names: PAN-90806 Eye Drops

Primary outcomes

  1. 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

Secondary outcomes

  1. The mean change in best-corrected visual acuity from baseline

    Time frame: Week 8

  2. 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)

  3. The mean number of rescue treatments during the study

    Time frame: Week 8

  4. Time to first rescue treatment

    Time frame: up to Week 8

Sponsors and collaborators

Lead sponsor

PanOptica, Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 18, 2015
Registry last updated
Sep 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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