A Pilot Study on the Effects of ILARIS® on Patients With Proliferative Diabetic Retinopathy (PDRP)
Status:
Terminated
Trial end date:
2014-11-01
Target enrollment:
Participant gender:
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.