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

Diabetic Macular Edema Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02842541
• Other study ID #: EBI-031-1
• Status: Withdrawn
• Phase: Phase 1
• First received: July 19, 2016
• Last updated: September 13, 2016
• Start date: September 2016
• Est. completion date: February 2018

Study information

• Verified date: September 2016
• Source: Eleven Biotherapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• EBI-031

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eleven Biotherapeutics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No