Study of Topical Ocular PAN-90806 in PDR

• Sponsor: PanOptica, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02475109
• Collaborator: (none)
• Enrollment: 10
• Locations: 2
• Arm: 1
• Duration (Months): 11
• Patients Per Site: 5
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Retinopathy	Drug: PAN-90806 Ophthalmic Solution	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Study Start Date: Aug 1, 2015
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: Jul 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. The mean change in best-corrected visual acuity from baseline [Week 8]

2. 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)

3. The mean number of rescue treatments during the study [Week 8]

4. Time to first rescue treatment [up to Week 8]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Valley Retina Institute	Harlingen	Texas	United States	78550
2	Valley Retina Institute	McAllen	Texas	United States	78503

Sponsors and Collaborators

• PanOptica, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: PanOptica, Inc.
• ClinicalTrials.gov Identifier: NCT02475109
• Other Study ID Numbers: PAN-01-201
• First Posted: Jun 18, 2015
• Last Update Posted: Sep 28, 2016
• Last Verified: Sep 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by PanOptica, Inc.: Proliferative Diabetic Retinopathy
• Additional relevant MeSH terms: Retinal Diseases; Diabetic Retinopathy; Ophthalmic Solutions

Study Results

No Results Posted as of Sep 28, 2016