- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01589029
A Pilot Study on the Effects of ILARIS® on Patients With Proliferative Diabetic Retinopathy (PDRP) (ILARIS)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Zurich, Switzerland, 8063
- Department of Ophthalmology, Triemli Hospital Zurich
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Signed and dated Informed Consent
American Diabetes Association (ADA) diagnostic criteria for type 1 (TD1) or type 2 (T2D) diabetes
Evidence of proliferative diabetic retinopathy with:
- Active retinal neovascularization defined by fluorescein angiography as non-high risk proliferative diabetic retinopathy (PDRP; NVD < 1/3 disc area; NVE < ½ disc area) or
- High risk PDRP treated with prior panretinal laser photocoagulation (PRP), showing persistent, active retinal neovascularization. The last session of PRP should not be within 12 weeks prior to enrolment.
Diabetes (Type I or II) must be stable which is defined as not requiring a change in medication over the last 4 weeks
Age ≥ 18
For female subjects of child-bearing age, a negative serum pregnancy test is mandatory. For subjects with reproductive potential, a willingness to utilize adequate contraception and not become pregnant. Adequate contraceptive measures include oral contraceptives (stable use for two or more cycles prior to Screening); IUD; Depo-Provera®; Norplant® System implants; condom or diaphragm used in conjunction with contraceptive sponge, foam or jelly; and abstinence.
Ability to regular follow-up visits
-
Exclusion Criteria:
Patients requiring laser coagulation or intravitreal therapy with steroids or anti-VEGF drugs for diabetic macular edema within the first 6 months after enrolment
Patients with laser coagulation or any intravitreal therapy within three months prior to enrollment Media opacification not allowing adequate retinal examination
Allergy to fluorescein (Fluorescein Angiography)
Known HIV antibody, hepatitis B surface antigen, and/or hepatitis C antibody
History of malignancy except basal cell skin carcinoma prior to study entry
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibody
History or evidence of active tuberculosis (TB) infection at Visit 1 or one of the risk factors for tuberculosis such as residence in a congregate setting (e.g. homeless shelter), substance abuse, health-care workers with unprotected exposure to patients who are at high risk of TB or patients with TB disease, close contact (i.e. share the same air space in a household or other enclosed environment for a prolonged period (days or weeks) with a person with active pulmonary TB disease within the last 12 months
History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection, at Visit 1, determined as defined by local guidelines/ local medical practice. If presence of tuberculosis is established then treatment (according to local guidelines) must have been completed prior to randomization
Live vaccinations within 3 months prior to the randomization visit or live vaccinations planned during the trial.
History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
Any biologic drugs targeting the immune system (for example, TNF blockers, anakinra, rituximab, abatacept, tocilizumab)
active atopic disease
history or symptoms of a demyelinating disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: CANAKINUMAB (ILARIS®)
|
subcutaneous injection every 8 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Regression of retinal neovascularizations (NVE and NVD) in FA.
Time Frame: 24 weeks
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Central retinal thickness measured by SD-OCT
Time Frame: 24 weeks
|
24 weeks
|
Best corrected visual acuity
Time Frame: 24 weeks
|
24 weeks
|
Change in HbA1c and inflammatory markers
Time Frame: 24 weeks
|
24 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stephan Michels, MD, MBA, Department of Ophthalmology, Triemli Hospital Zuerich
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CACZ885MCH01T
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Proliferative Diabetic Retinopathy
-
University of CataniaUnknownProliferative Diabetic Retinopathy | Non Proliferative Diabetic RetinopathyItaly
-
Asociación para Evitar la Ceguera en MéxicoUnknownProliferative Diabetic Retinopathy | Non Proliferative Diabetic RetinopathyMexico
-
Valo Health, Inc.RecruitingProliferative Diabetic Retinopathy | Non-proliferative Diabetic RetinopathyUnited States
-
Asociación para Evitar la Ceguera en MéxicoUnknownNon Proliferative Diabetic Retinopathy. | Proliferative Diabetic Retinopathy.Mexico
-
Ocuphire Pharma, Inc.CompletedDiabetic Retinopathy | Diabetic Macular Edema | NPDR - Non Proliferative Diabetic Retinopathy | PDR - Proliferative Diabetic RetinopathyUnited States
-
King Khaled Eye Specialist HospitalCompletedDiabetic Macular Edema | Proliferative Diabetic Retinopathy | Non-proliferative Diabetic RetinopathySaudi Arabia
-
Retina Macula InstituteAllerganCompletedDiabetic Macular Edema | Proliferative Diabetic Retinopathy | Non-proliferative Diabetic RetinopathyUnited States
-
Asociación para Evitar la Ceguera en MéxicoCompletedProliferative Diabetic Retinopathy | Severe Nonproliferative | Active Photocoagulated Diabetic RetinopathyMexico
-
Jaeb Center for Health ResearchNational Eye Institute (NEI); Genentech, Inc.CompletedProliferative Diabetic RetinopathyUnited States
-
CHU de ReimsCompletedProliferative Diabetic RetinopathyFrance
Clinical Trials on CANAKINUMAB (ILARIS®)
-
Rabin Medical CenterUnknown
-
Charite University, Berlin, GermanyNovartis PharmaceuticalsCompletedVasculitis | UrticariaGermany
-
Charite University, Berlin, GermanyTerminatedAdult-Onset Still´s DiseaseGermany
-
Charite University, Berlin, GermanyNovartis PharmaceuticalsCompleted
-
Radboud University Medical CenterNovartisCompleted
-
Mario Negri Institute for Pharmacological ResearchNovartis PharmaceuticalsTerminated
-
Novartis PharmaceuticalsNo longer availableCytokine Release Syndrome in COVID-19-induced Pneumonia
-
University of LeipzigNovartis PharmaceuticalsRecruitingMyelodysplastic Syndromes | AnemiaGermany
-
University of ZurichUnknownChronic Idiopathic UrticariaSwitzerland
-
University of ZurichCompleted