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

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ClinicalTrials.gov Identifier: NCT02753400
Recruitment Status : Completed
First Posted : April 27, 2016
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Acucela Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Proliferative Diabetic Retinopathy Drug: emixustat hydrochloride Other: Placebo Phase 2

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  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 2016
Actual Primary Completion Date : November 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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.

Drug: emixustat hydrochloride
Tablet for oral administration
Other Name: ACU-4429, Emixustat HCl

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




Primary Outcome Measures :
  1. 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: 12 weeks ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02753400


Locations
United States, California
Retina Institute of California
Arcadia, California, United States
Sponsors and Collaborators
Acucela Inc.
Investigators
Study Director: Responsible Medical Officer Acucela Inc.

Responsible Party: Acucela Inc.
ClinicalTrials.gov Identifier: NCT02753400     History of Changes
Other Study ID Numbers: 4429-203
First Posted: April 27, 2016    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases