Proliferative Diabetic RetinopathyPhase 1ILARISNCT01589029
A Pilot Study on the Effects of ILARIS® on Patients With Proliferative Diabetic Retinopathy (PDRP)
A Phase 1 study testing CANAKINUMAB (ILARIS®) in people with Proliferative Diabetic Retinopathy, run by PD Dr. med. Stephan Michels at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proliferative Diabetic Retinopathy
- What is being tested?
- CANAKINUMAB (ILARIS®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2012to Nov 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- -
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Ophthalmology, Triemli Hospital Zurich
Zurich, Canton of Zurich, 8063
About this study
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
- Being tested
- CANAKINUMAB (ILARIS®)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CANAKINUMAB (ILARIS®)Drug
subcutaneous injection every 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| CANAKINUMAB (ILARIS®) | Other | Not described Receives: Drug: CANAKINUMAB (ILARIS®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regression of retinal neovascularizations (NVE and NVD) in FA.
Measured: 24 weeks
Secondary outcomes (3)
Central retinal thickness measured by SD-OCT
Measured: 24 weeks
Best corrected visual acuity
Measured: 24 weeks
Change in HbA1c and inflammatory markers
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2012 (estimated)
- Study startApr 2012
- Primary completionNov 2014
- Study completionNov 2014
Why it stopped: The results of the interim analysis showed that the primary endpoint was not met
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proliferative Diabetic RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- PD Dr. med. Stephan Michels
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis, University Hospital, Zürich
- Responsible party
- Sponsor-investigator, PD Dr. med. Stephan Michels, Triemli Hospital
- Investigators
- Stephan Michels, MD, MBA, Principal investigator, Department of Ophthalmology, Triemli Hospital Zuerich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01589029
- Sponsor's protocol ID
- CACZ885MCH01T
- Acronym
- ILARIS
- Status last verified
- Nov 2015
- First submitted
- 27 Apr 2012
- Last updated
- 24 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on the Effects of ILARIS® on Patients With Proliferative Diabetic Retinopathy (PDRP)
- ClinicalTrials.gov ID
- NCT01589029
- Acronym / sponsor ID
- ILARIS / CACZ885MCH01T
- Conditions
- Proliferative Diabetic Retinopathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The results of the interim analysis showed that the primary endpoint was not met
- Enrolment
- 6 participants (actual)
- Lead sponsor
- PD Dr. med. Stephan MichelsUniversity, hospital or other
- Collaborators
- Novartis, University Hospital, Zürich
- Study start
- Apr 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 1 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CANAKINUMAB (ILARIS®) | Other | Drug: CANAKINUMAB (ILARIS®) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed and dated Informed Consent
- American Diabetes Association (ADA) diagnostic criteria for type 1 (TD1) or type 2 (T2D) diabetes
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CANAKINUMAB (ILARIS®)subcutaneous injection every 8 weeks | Drug | CANAKINUMAB (ILARIS®) |
Primary outcome
Regression of retinal neovascularizations (NVE and NVD) in FA.
Time frame: 24 weeks
3 secondary outcomes
Central retinal thickness measured by SD-OCT
Time frame: 24 weeks
Best corrected visual acuity
Time frame: 24 weeks
Change in HbA1c and inflammatory markers
Time frame: 24 weeks
Results and safety
The study was stopped early (reason given: The results of the interim analysis showed that the primary endpoint was not met). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan Michels, MD, MBA principal investigator
Department of Ophthalmology, Triemli Hospital Zuerich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CANAKINUMAB (ILARIS®) in people with Proliferative Diabetic Retinopathy, run by PD Dr. med. Stephan Michels at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The results of the interim analysis showed that the primary endpoint was not met). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regression of retinal neovascularizations (NVE and NVD) in FA. (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2015.