Clinical Trials Logo
  1. Home
  2. Other
  3. NCT01589029

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

Proliferative Diabetic Retinopathy Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01589029
Study type Interventional
Source Triemli Hospital
Contact
Status Terminated
Phase Phase 1
Start date April 2012
Completion date November 2014
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT01921192 - Effect of Folic Acid, Vitamin B6 and Vitamin B12 in Diabetic Retinopathy Phase 4
Recruiting NCT01044875 - Trial of Yellow 577 nm Laser Versus Green 532 nm Laser for Proliferative Diabetic Retinopathy N/A
Active, not recruiting NCT00993525 - Intravitreal Ranibizumab For Persistent New Vessels In Diabetic Retinopathy(Inipe Study) Phase 1/Phase 2
Completed NCT01307072 - Compliance to Ophthalmic Follow-up Examinations and Surgical Outcome for Proliferative Diabetic Retinopathy N/A
Completed NCT01758757 - Comparison of Small-gauge Vitrectomy and Conventional Vitrectomy for Proliferative Diabetic Retinopathy N/A
Completed NCT00600236 - HLA and it Relation With the Development of Proliferative Diabetic Retinopathy in Mexican Population Phase 3
Completed NCT05414149 - Efficacy and Safety Comparison of IVR and IVC Before Vitrectomy in Proliferative Diabetic Retinopathy N/A
Completed NCT05408416 - Comparison of Surgery Outcome Between Preoperative IVR and Intraoperative IVR in PPV for PDR N/A
Not yet recruiting NCT04464694 - Pre-vitrectomy Intravitreal Ranibizumab for Patients With Proliferative Diabetic Retinopathy Combined With Diabetic Macular Edema Phase 4
Not yet recruiting NCT03633266 - Anti-VEGF Instead of Intraoperative PRP in Proliferative Diabetic Retinopathy N/A
Completed NCT03490318 - Effectiveness of Multimodal Imaging for the Evaluation of Retinal Oedema And New vesseLs in Diabetic Retinopathy
Completed NCT01627977 - Association of Lutein, Zeaxanthin and Brilliant Blue in Chromovitrectomy Phase 3
Completed NCT00776763 - Ocular Growth Factors Profile in Proliferative Retinopathies Before and After Intravitreal Bevacizumab Phase 2
Terminated NCT00563043 - Changes in Electroretinogram and Contrast Sensitivity After PASCAL Treatment Phase 4
Completed NCT00682240 - Morphological and Functional Retinal Changes Following Retinal Photocoagulation Phase 4
Terminated NCT00563628 - Changes in Macular Thickness After Patterns Scan Laser Phase 4
Completed NCT00446381 - Effect of Macugen(Pegaptanib)on Surgical Outcomes and VEGF Levels in Diabetic Patients With PDR (Diabetic Retinopathy or CSDME (Macular Edema) N/A
Completed NCT02879422 - Genetic Markers and Proliferative Diabetic Retinopathy N/A
Enrolling by invitation NCT02911311 - Conbercept vs Panretinal Photocoagulation for the Management of Proliferative Diabetic Retinopathy N/A
Recruiting NCT05514925 - Cryoapplication Versus Anti-VEGF Before Diabetic Vitrectomy Phase 4