Safety Study of Intravitreal EBI-031 Given as a Single or Repeat Injection to Subjects With Diabetic Macular Edema

An Open Label, Multi-Center, Safety Study of Intravitreal EBI-031, an Interleukin-6 (IL-6) Inhibitor, Administered as Single and Repeat Injections in Subjects With Diabetic Macular Edema (DME)

The purpose of the study is to evaluate the safety, tolerability, immunogenicity, and pharmacokinetics of up to 3 dose levels of EBI-031 given as an intravitreal injection in subjects with diabetic macular edema. There are two arms to the study, a single dose arm (1 dose) and a repeat dose arm (1 dose each month for 3 months). Eligible subjects will initially enroll in the single dose arm and 3 to 6 subjects will be dosed at each of the 3 dose levels. Safety will be assessed over the 28 days after the single dose prior to moving to the next higher dose level. Once all subjects in the single dose arm have been dosed with EBI-031 and the safety has been assessed eligible subjects will begin enrolling in the repeat dose arm. Subjects in the repeat dose arm will receive one dose each month for 3 months and will be assessed for safety. Escalation to the next higher dose will occur once it is determined safe to proceed to the next dose level. Six subjects will be dosed at each of the 3 dose levels.

Study Overview

• Status: Withdrawn
• Conditions: Diabetic Macular Edema
• Intervention / Treatment: Drug: EBI-031

• Study Type: Interventional
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Give written voluntary informed consent and any authorizations required by local law
• Have a diagnosis of Type 1 or 2 diabetes mellitus
• Have decreased vision determined primarily to be the result of DME in the study eye
• Mean central foveal thickness on Spectral Domain Ocular Coherence Tomography (SD-OCT)> 325 in the study eye within 2 weeks of dosing
• Have best corrected Early Treatment of Diabetic Retinopathy Study (ETDRS) letter score of <73 (~20/40) and >19 (~20/400) in the study eye within 2 weeks of dosing.

Exclusion Criteria:

• Female that is pregnant and lactating
• Any prior history of anti-interleukin 6 (anti-IL-6) treatment, for example: tocilizumab, sirukumab, sarilumab, olokizumab
• Any concurrent biologics for immune disease such as anti-tumor necrosis factor (TNF): Enbrel (etanercept), Humira (adalimumab), Remicade (infliximab); an anti-interleukin 12 (anti-IL-12): Stelara (ustekinumab); or an anti-interleukin 1 (anti-IL-1): Kineret (anakinra), Ilaris (canakinumab), Arcalyst (rilonacept).
• Unstable, uncontrolled diabetes defined as hemoglobin A1C (HbA1C)≥10.5% within 3 months prior to dosing of EBI-031
• Received intravitreal anti-vascular endothelial growth factor (anti-VEGF) such as Eylea (aflibercept) within 8 weeks, Lucentis (ranibizumab) and Avastin (bevacizumab) within 4 months prior to EBI-031
• Significant renal disease, liver disease, or acute congestive heart failure
• History of myocardial infarction (MI), stroke, or transient ischemic attack (TIA)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single dose arm; Subjects will receive a single intravitreal dose of EBI-031	Drug: EBI-031
Experimental: Repeat dose arm; Subjects will receive an intravitreal dose of EBI-031 monthly for 3 months	Drug: EBI-031

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety, tolerability, and immunogenicity as measured by adverse events and anti-drug antibody development of single and repeat doses of EBI-031	Number of Participants With Abnormal Laboratory Values, Adverse Events, and/or antibodies to EBI-031	Measure over the 84 days

Collaborators and Investigators

• Sponsor: Eleven Biotherapeutics
• Investigators: Study Director: Karen Tubridy, Eleven Biotherapeutics

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): February 1, 2018

Study Registration Dates

• First Submitted: July 19, 2016
• First Submitted That Met QC Criteria: July 22, 2016
• First Posted (Estimate): July 25, 2016

Study Record Updates

• Last Update Posted (Estimate): September 15, 2016
• Last Update Submitted That Met QC Criteria: September 13, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema
• Other Study ID Numbers: EBI-031-1