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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Triemli Hospital.
Recruitment status was  Recruiting
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

April 27, 2012
April 27, 2012
April 2012
September 2013   (final data collection date for primary outcome measure)
Regression of retinal neovascularizations (NVE and NVD) in FA. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Pilot Study on the Effects of ILARIS® on Patients With Proliferative Diabetic Retinopathy (PDRP)
A Pilot Study on the Effects of ILARIS® on Patients With Proliferative Diabetic Retinopathy (PDRP)

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Proliferative Diabetic Retinopathy
Drug: CANAKINUMAB (ILARIS®)
subcutaneous injection every 8 weeks
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
May 2014
September 2013   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact: Stephan Michels, MD, MBA +41444663200 studien.augenklinik@zuerich.ch
Switzerland
 
NCT01589029
CACZ885MCH01T
Yes
PD Dr. med. Stephan Michels, Triemli Hospital
PD Dr. med. Stephan Michels
  • Novartis
  • University Hospital, Zürich
Principal Investigator: Stephan Michels, MD, MBA Department of Ophthalmology, Triemli Hospital Zuerich
Triemli Hospital
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP