Study of Topical Ocular PAN-90806 in PDR

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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02475109

Enrollment

Registered

2015-06-18

Start date

2015-08-31

Completion date

2016-07-31

Last updated

2016-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinopathy

Keywords

Proliferative Diabetic Retinopathy

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.

Interventions

DRUGPAN-90806 Ophthalmic Solution

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026