MedTrace Logo

A Pilot Study on the Effects of ILARIS® on Patients With Proliferative Diabetic Retinopathy (PDRP)

NCT01589029 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2015-11-24

No results posted yet for this study

Summary

The pilot study evaluates the efficacy and safety of Canakinumab (ILARIS®) in subjects with proliferative diabetic retinopathy secondary to type 1 and 2 diabetes. Ten subjects will be enrolled to receive 150 mg Canakinumab (ILARIS®) by subcutaneous injection. Beginning on day 0, each subject will receive a subcutaneous injection of study drug every 8 weeks for 16 weeks, a total of 3 injections. All subjects will undergo regular follow-up assessments every 8 weeks through 24 weeks. Fluorescein angiography (FA) is repeated every 8 weeks. In case of progression of retinal neovascularization on FA panretinal laser photocoagulation is administered as rescue therapy. The primary outcome is the regression of retinal neovascularizations (NVE and NVD) in FA at 24 weeks. In addition to key secondary outcomes including regression of diabetic macular edema, change in best-corrected visual acuity, change in HbA1c levels and change in markers of systemic inflammation. Safety will be assessed by measurements of vital signs, clinical laboratory assessments, and the recording of adverse clinical events.

Conditions

  • Proliferative Diabetic Retinopathy

Interventions

DRUG

CANAKINUMAB (ILARIS®)

subcutaneous injection every 8 weeks

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • University Hospital, Zürich

    collaborator OTHER

  • PD Dr. med. Stephan Michels

    lead OTHER

Principal Investigators

  • Stephan Michels, MD, MBA · Department of Ophthalmology, Triemli Hospital Zuerich

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01589029 on ClinicalTrials.gov