UveitisPhase 2NCT00803816
Everolimus for the Treatment of Uveitis Unresponsive to Cyclosporine A
A Phase 2 study testing everolimus in people with Uveitis, run by Carsten Heinz at 1 site in Germany.
Trial summary
Study efficacy of everolimus on course of uveitis: obtain quiescence of inflammation after start of treatment duration to obtain quiescence of inflammation number of patients with quiescence of inflammation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitis
- What is being tested?
- everolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2007to Dec 2010
- Phase
- Phase 2
- 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
- endogenous intermediate or posterior uveitis
- no quiesence in previous 3 months under systemic and topical steroids or systemic cyclosporine A
- indication for steroid sparing therapy
- uveitis related vision threating complications
- negative pregnancy test
- effective contraception
Who cannot join
- Ophthalmic parameters:
- silicone oil in anterior chamber of both eyes para- or intraocular corticosteroid injections within previous 8 weeks
- opacities of optic media that obscure visualization of anterior or posterior eye segments
- General parameters:
- requirement for combined immunosuppression for systemic immune-mediated disease contraindication against everolimus or cyclosporine A
- positive tuberculine test (GT 10
Show all 9Show fewer
- currently immunosuppressive therapy with immunosuppressive drug other than cyclosporine
- poor compliance
- known intolerance to medication
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Ophthalmology at St. Franziskus Hospital
Münster, 48145
About this study
Study efficacy of everolimus on course of uveitis:
- obtain quiescence of inflammation after start of treatment
- duration to obtain quiescence of inflammation
- number of patients with quiescence of inflammation
Read the detailed description
occurence of new complications from uveitis
- course of visual acuity (LogMAR): percentage of patients with visual loss of 10 or more numbers on ETDRS as compared to baseline
- change of recurrence rate as compared to time before everolimus treatment
- occurence of recurrence after obtaining remission with everolimus treatment
- duration to occurence of recurrence o number of patients with recurrence
- corticosparing effect from everolimus
- number of patients without topical corticosteroids; number of patients with reduced topical corticosteroids (<3x/daily)
- number of patients without systemic corticosteroids; number of patients with reduced systemic corticosteroids (<10mg/daily)
- efficacy of uveitis within 12 months
- maintenance of remission after withdrawel of everolimus treatment at 12 months o course of cystoid macula edema (FLA, OCT)
- Conditions
- Uveitis
- Being tested
- everolimus
- Keywords
- endogoneous, posterior, intermediate
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
everolimusDrug
everolimus 1.0 - 2.5mg oral daily dosage
| Study group | Role | What they receive |
|---|---|---|
| Addition of everolimus to standard care | Other | refractive to cyclosporine A (CsA) received additional everolimus. Receives: Drug: everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inactivity of uveitis
Measured: 1 year
Secondary outcomes (1)
Reoccurence of uveitis
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2008 (estimated)
- Study startNov 2007
- Primary completionSep 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UveitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carsten Heinz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Carsten Heinz, St. Franziskus Hospital
- Investigators
- Arnd Heiligenhaus, MD, Principal investigator, Department of Ophthalmology at St. Franziskus Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00803816
- Sponsor's protocol ID
- 2006-004876-10
- Status last verified
- May 2015
- First submitted
- 5 Dec 2008
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Everolimus for the Treatment of Uveitis Unresponsive to Cyclosporine A
- ClinicalTrials.gov ID
- NCT00803816
- Acronym / sponsor ID
- 2006-004876-10
- Conditions
- Uveitis
- Keywords
- endogoneous, posterior, intermediate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Carsten HeinzUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 8 Dec 2008 (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.
Study efficacy of everolimus on course of uveitis:
- obtain quiescence of inflammation after start of treatment
- duration to obtain quiescence of inflammation
- number of patients with quiescence of inflammation
Detailed description
occurence of new complications from uveitis
- course of visual acuity (LogMAR): percentage of patients with visual loss of 10 or more numbers on ETDRS as compared to baseline
- change of recurrence rate as compared to time before everolimus treatment
- occurence of recurrence after obtaining remission with everolimus treatment
- duration to occurence of recurrence o number of patients with recurrence
- corticosparing effect from everolimus
- number of patients without topical corticosteroids; number of patients with reduced topical corticosteroids (<3x/daily)
- number of patients without systemic corticosteroids; number of patients with reduced systemic corticosteroids (<10mg/daily)
- efficacy of uveitis within 12 months
- maintenance of remission after withdrawel of everolimus treatment at 12 months o course of cystoid macula edema (FLA, OCT)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Addition of everolimus to standard care | Other | Drug: everolimusrefractive to cyclosporine A (CsA) received additional everolimus. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- endogenous intermediate or posterior uveitis
- no quiesence in previous 3 months under systemic and topical steroids or systemic cyclosporine A
- indication for steroid sparing therapy
- uveitis related vision threating complications
- negative pregnancy test
Key exclusion criteria (9 listed)
- silicone oil in anterior chamber of both eyes para- or intraocular corticosteroid injections within previous 8 weeks
- opacities of optic media that obscure visualization of anterior or posterior eye segments
- requirement for combined immunosuppression for systemic immune-mediated disease contraindication against everolimus or cyclosporine A
- positive tuberculine test (GT 10
- currently immunosuppressive therapy with immunosuppressive drug other than cyclosporine
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 |
|---|---|---|
| everolimuseverolimus 1.0 - 2.5mg oral daily dosage | Drug | Addition of everolimus to standard care |
Primary outcome
Inactivity of uveitis
Time frame: 1 year
1 secondary outcome
Reoccurence of uveitis
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 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.
Arnd Heiligenhaus, MD principal investigator
Department of Ophthalmology at St. Franziskus Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing everolimus in people with Uveitis, run by Carsten Heinz at 1 site in Germany.
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 6 inclusion and 9 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: finished, as of the sponsor's last update on 27 May 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 Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Inactivity of uveitis (time frame: 1 year). 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 27 May 2015.