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

Primary Purpose

Diabetic Macular Edema

Status

Withdrawn

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

EBI-031

About this trial

This is an interventional treatment trial for Diabetic Macular Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Single dose arm

Repeat dose arm

Arm Description

Subjects will receive a single intravitreal dose of EBI-031

Subjects will receive an intravitreal dose of EBI-031 monthly for 3 months

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02842541

First Posted

July 19, 2016

Last Updated

September 13, 2016

Sponsor

Eleven Biotherapeutics

1. Study Identification

Unique Protocol Identification Number

NCT02842541

Brief Title

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

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Withdrawn

Why Stopped

New study planned.

Study Start Date

September 2016 (undefined)

Primary Completion Date

October 2017 (Anticipated)

Study Completion Date

February 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eleven Biotherapeutics

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Macular Edema

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single dose arm

Arm Type

Experimental

Arm Description

Subjects will receive a single intravitreal dose of EBI-031

Arm Title

Repeat dose arm

Arm Type

Experimental

Arm Description

Subjects will receive an intravitreal dose of EBI-031 monthly for 3 months

Intervention Type

Drug

Intervention Name(s)

EBI-031

Primary Outcome Measure Information:

Title

Safety, tolerability, and immunogenicity as measured by adverse events and anti-drug antibody development of single and repeat doses of EBI-031

Description

Number of Participants With Abnormal Laboratory Values, Adverse Events, and/or antibodies to EBI-031

Time Frame

Measure over the 84 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karen Tubridy

Organizational Affiliation

Eleven Biotherapeutics

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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