Study of Topical Ocular PAN-90806 in PDR

Diabetic Retinopathy Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02475109
• Other study ID #: PAN-01-201
• Status: Completed
• Phase: Phase 1
• First received: June 13, 2015
• Last updated: September 27, 2016
• Start date: August 2015
• Est. completion date: July 2016

Study information

• Verified date: September 2016
• Source: PanOptica, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

Drug:
• PAN-90806 Ophthalmic Solution

Locations

Country	Name	City	State
United States	Valley Retina Institute	Harlingen	Texas
United States	Valley Retina Institute	McAllen	Texas

Sponsors (1)

Lead Sponsor	Collaborator
PanOptica, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients with Adverse Events	Safety will be assessed based upon the incidence of all adverse events, ocular and systemic	2 months	Yes
Secondary	The mean change in best-corrected visual acuity from baseline		Week 8	No
Secondary	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)	Week 4 and Week 8	No
Secondary	The mean number of rescue treatments during the study		Week 8	No
Secondary	Time to first rescue treatment		up to Week 8	No