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

NCT ID: NCT01589029

Last Updated: 2015-11-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2014-11-30

Brief 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.

Conditions

Proliferative Diabetic Retinopathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CANAKINUMAB (ILARIS®)

Group Type: OTHER

CANAKINUMAB (ILARIS®)

Intervention Type: DRUG

subcutaneous injection every 8 weeks

Interventions

CANAKINUMAB (ILARIS®)

subcutaneous injection every 8 weeks

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

University Hospital, Zürich

OTHER

Sponsor Role: collaborator

PD Dr. med. Stephan Michels

OTHER

Sponsor Role: lead

Responsible Party

PD Dr. med. Stephan Michels

Stephan Michels, MD, MBA, Associate Professor, Head Medical Retina, Department of Ophthalmology, Triemli Hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Stephan Michels, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology, Triemli Hospital Zuerich

Locations

Department of Ophthalmology, Triemli Hospital Zurich

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

Other Identifiers

CACZ885MCH01T

Identifier Type: -

Identifier Source: org_study_id