Study to Evaluate Effects of Emixustat Hydrochloride in Subjects With Proliferative Diabetic Retinopathy

Proliferative Diabetic Retinopathy Clinical Trial

Official title:

A Multicenter, Randomized, Double-Masked, Placebo-Controlled, Pilot Study to Evaluate Effects of Emixustat Hydrochloride on Aqueous Humor Biomarkers Associated With Proliferative Diabetic Retinopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02753400
• Other study ID #: 4429-203
• Status: Completed
• Phase: Phase 2
• Start date: May 2016
• Est. completion date: December 2017

Study information

• Verified date: April 2021
• Source: Kubota Vision Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the effects of oral emixustat hydrochloride (emixustat) on aqueous humor biomarkers associated with proliferative diabetic retinopathy (PDR) from baseline to week 12.

Description:

This is a multicenter, randomized, double-masked, placebo-controlled study to evaluate the effects of emixustat in subjects with PDR. Subjects will be randomly assigned to either emixustat or placebo arms and treated once daily (QD) for 12 weeks. Doses of emixustat will be doubled on a weekly basis until week 4 after which all subjects will be held at a stable dose for the remainder of the 12-week dosing regimen. Subjects in the placebo group will be mock-titrated on the same schedule as those in the emixustat arm.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Able and willing to provide written informed consent

• Documented diagnosis of type 1 or type 2 diabetes mellitus

• Meets specific ocular criteria for the study eye including but not limited to, the presence of PDR with or without diabetic macular edema in study eye for which treatment can be deferred for at least 4 weeks after Day 1 visit

• Media clarity, pupillary dilation, and subject cooperation sufficient to obtain adequate assessments

Exclusion Criteria:

• Any condition that would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease or glycemic control)

• History of myocardial infarction or other acute cardiac event

• History of chronic renal failure requiring dialysis or kidney transplant

• Prior participation in any clinical study of emixustat

• Treatment with any investigational study drug within 30 days of screening

• Known allergy to fluorescein sodium for injection in angiography

• Treatment with specific prohibited medications or therapy beginning 4 weeks prior to screening and throughout the duration of the study

• History of systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization

• Pre-specified laboratory abnormalities at screening

• Specific ocular characteristics in the study eye

• Male subjects who are not surgically sterile and are not willing to practice a medically accepted method of birth control with their female partner of childbearing potential from screening through 30 days following completion of the study

• Female subjects of childbearing potential who are not willing to practice a medically accepted method of birth control with their non-surgically sterile male sexual partner from screening through 30 days following completion of the study

• Female subjects who are pregnant or lactating

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Proliferative Diabetic Retinopathy
• Retinal Diseases

Intervention

Drug:
• emixustat hydrochloride
Tablet for oral administration

Other:
• Placebo
Placebo tablets for oral administration contain only inactive ingredients

Locations

Country	Name	City	State
United States	Retina Institute of California	Arcadia	California

Sponsors (1)

Lead Sponsor	Collaborator
Kubota Vision Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Aqueous Humor Concentration of the Following Biomarkers:IL-6, IL-8, IP-10, PDGF-AA, TGFß-1, MCP-1, IL-1ß, and VEGF, to be Reported in pg/mL Values	All values for IL-1ß were below the lower limit of detection and were recorded as zero. Tests for IP-10 and MCP-1 failed accuracy and stability testing during assay development and were dropped from the study. The assay for PDGF-AA could not be developed.and results were not reported.	Baseline and 12 weeks