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

This study is currently recruiting participants.
Verified April 2012 by Triemli Hospital
Sponsor:
Collaborators:
Novartis
University Hospital, Zürich
Information provided by (Responsible Party):
PD Dr. med. Stephan Michels, Triemli Hospital
ClinicalTrials.gov Identifier:
NCT01589029
First received: April 27, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Proliferative Diabetic Retinopathy
Drug: CANAKINUMAB (ILARIS®)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study on the Effects of ILARIS® on Patients With Proliferative Diabetic Retinopathy (PDRP)

Resource links provided by NLM:


Further study details as provided by Triemli Hospital:

Primary Outcome Measures:
  • Regression of retinal neovascularizations (NVE and NVD) in FA. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Central retinal thickness measured by SD-OCT [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Best corrected visual acuity [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in HbA1c and inflammatory markers [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: April 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: CANAKINUMAB (ILARIS®)
    subcutaneous injection every 8 weeks
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  1. 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
  2. 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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01589029

Contacts
Contact: Stephan Michels, MD, MBA +41444663200 studien.augenklinik@zuerich.ch

Locations
Switzerland
Department of Ophthalmology, Triemli Hospital Zurich Recruiting
Zurich, Switzerland, 8063
Contact: Sarah Eisenstein    +4144466 ext 3200    studien.augenklinik@zuerich.ch   
Sponsors and Collaborators
PD Dr. med. Stephan Michels
Novartis
University Hospital, Zürich
Investigators
Principal Investigator: Stephan Michels, MD, MBA Department of Ophthalmology, Triemli Hospital Zuerich
  More Information

No publications provided

Responsible Party: PD Dr. med. Stephan Michels, Stephan Michels, MD, MBA, Associate Professor, Head Medical Retina, Department of Ophthalmology, Triemli Hospital, Triemli Hospital
ClinicalTrials.gov Identifier: NCT01589029     History of Changes
Other Study ID Numbers: CACZ885MCH01T
Study First Received: April 27, 2012
Last Updated: April 27, 2012
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 15, 2014