Study of Topical Ocular PAN-90806 in PDR

Phase 1

Completed

• Conditions: Diabetic Retinopathy
• Interventions: Drug: PAN-90806 Ophthalmic Solution

• Registration Number: NCT02475109
• Lead Sponsor: PanOptica, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-13
• Study First Submitted QC: 2015-06-17
• Study First Posted: 2015-06-18
• Study Start: 2015-08
• Primary Completion: 2016-05
• Study Completion: 2016-07
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-27
• Last Update Posted: 2016-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PAN-90806 Ophthalmic Solution	PAN-90806 Ophthalmic Solution	PAN-90806 Ophthalmic Solution taken daily for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Number of Patients with Adverse Events	2 months	Safety will be assessed based upon the incidence of all adverse events, ocular and systemic

Secondary Outcome Measures

Name	Time	Method
The mean change in best-corrected visual acuity from baseline	Week 8
Change in preretinal neovascularization	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)
The mean number of rescue treatments during the study	Week 8
Time to first rescue treatment	up to Week 8

Trial Locations

Locations (1)

Valley Retina Institute; 🇺🇸 McAllen, Texas, United States