Study to Evaluate Effects of Emixustat Hydrochloride in Subjects With Proliferative Diabetic Retinopathy
April 27, 2021 updated by: Kubota Vision Inc.
A Multicenter, Randomized, Double-Masked, Placebo-Controlled, Pilot Study to Evaluate Effects of Emixustat Hydrochloride on Aqueous Humor Biomarkers Associated With Proliferative Diabetic Retinopathy
To evaluate the effects of oral emixustat hydrochloride (emixustat) on aqueous humor biomarkers associated with proliferative diabetic retinopathy (PDR) from baseline to week 12.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Arcadia, California, United States
- Retina Institute of California
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Emixustat hydrochloride
Week 1- Four tablets (2 placebo, 2 emixustat HCl Strength A) Week 2- Four tablets (2 placebo, 2 emixustat HCl Strength B) Week 3- Four tablets (2 placebo, 2 emixustat HCl Strength C) Week 4- Four emixustat HCl tablets (Strength C) All tablets are administered orally once daily. After week 4, all subjects will be held at a stable dose for the remainder of the 12-week dosing regimen. |
Tablet for oral administration
Other Names:
Placebo tablets for oral administration contain only inactive ingredients
|
|
Placebo Comparator: Placebo
Four placebo tablets are administered orally once daily for 12 weeks; Subjects in the placebo group will be mock-titrated on the same schedule as those in the active arm.
|
Placebo tablets for oral administration contain only inactive ingredients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Aqueous Humor Concentration of the Following Biomarkers:IL-6, IL-8, IP-10, PDGF-AA, TGFβ-1, MCP-1, IL-1β, and VEGF, to be Reported in pg/mL Values
Time Frame: Baseline and 12 weeks
|
All values for IL-1β 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Responsible Medical Officer, Kubota Vision Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2016
Primary Completion (Actual)
November 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
April 19, 2016
First Submitted That Met QC Criteria
April 25, 2016
First Posted (Estimate)
April 27, 2016
Study Record Updates
Last Update Posted (Actual)
May 19, 2021
Last Update Submitted That Met QC Criteria
April 27, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4429-203
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.