Anterior UveitisPhase 2NCT00823173
Exploratory Study on Topical ESBA105 in Acute Anterior Uveitis
A Phase 2 study testing ESBA105 in people with Anterior Uveitis, run by ESBATech AG at 3 sites in Germany.
Trial summary
The purpose of this study is to determine whether ESBA105, a topically applied TNF-alpha inhibitor, is safe and clinically active when applied to the eye of patients suffering from acute anterior uveitis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Uveitis
- What is being tested?
- ESBA105
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesGermany
- Study dates
- Jan 2009to 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
- Signed and dated informed consent.
- Patients with the typical presentation of HLA-B27 positive AAU (unilateral, painful anterior uveitis of sudden onset).
- 2+ anterior chamber cells according to the SUN Working Group criteria, as assessed by slit lamp biomicroscopy.
- Start of the typical first symptoms of the current attack, defined as the point in time when the patient felt the first sensation of the attack, within the last 72 hours before initiation of treatment with the study medication.
- Negative pregnancy test for females of childbearing potential (pre menopausal, <2 years post-menopausal, not surgically sterile).
- Patients with a negative QuantiFERON TB Gold test result.
- Patients who currently have no clinically apparent symptoms of an HLA B27 associated acute extraocular disorder requiring systemic immunosuppressive therapy.
- Patients who are willing and able to cooperate with study requirements.
Who cannot join
- IOP elevation requiring therapy.
- Uncontrolled diabetes mellitus and diabetic retinopathy.
- Patients with a single eye or a pinhole Snellen visual acuity 20/200 or worse in the non study eye.
- Patients with 1+ or less anterior chamber cells.
- Patients with 3+ or 4+ anterior chamber cells or hypopyon.
- Patients in whom the time of the beginning of the current attack can not be determined.
Show all 19Show fewer
- Patients exhibiting corneal ulceration or a history of recurrent herpetic keratitis or clinical evidence of herpetic dermatitis.
- Patients currently treated with topical corticosteroids.
- Patients treated with systemic immunosuppressive therapy within the last 2 months.
- Patients treated with a systemically administered TNF-alpha inhibitor within the last 2 months.
- Pregnant or breast-feeding women or women of childbearing potential, who with their partners refuse to use 2 reliable methods of contraception (including 1 barrier method) during the study.
- Male patients with a female partner who could become pregnant and who refuse, with their partner, to use 2 reliable methods of contraception (including 1 barrier method) during the study.
- Patients whose clinical presentation is suggestive for an active bacterial, viral or fungal infection anywhere in the body.
- Patients with history of recurrent infections, or a clinical presentation suggestive of a chronic infection requiring antimicrobial therapy (e.g. syphilis) including active episodes of serious viral infections by, e.g. herpes simplex, herpes zoster, cytomegalic or hepatitis viruses or clinical signs of fungal infections, such as histoplasmosis, aspergillosis or coccidiomycosis.
- Patients presenting with higher intraocular pressure in the uveitic eye than in the contralateral eye.
- Patients with known carrier status of human immunodeficiency virus, hepatitis B or hepatitis C.
- Patients with a history of demyelinating disease (multiple sclerosis) or optic neuritis.
- Patients with positive or unclear QuantiFERON TB Gold test result or history of high risk exposure to Mycobacterium tuberculosis.
- Patients with known coexisting malignancy.
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Charité Humboldt University
Berlin, State of Berlin, 13353
Uveitis-Zentrum Franziskus Hospital
Münster, North Rhine-Westphalia, 48145
Universitäts-Augenklinik
Tübingen, Baden-Würtemberg, 72076
About this study
Official title: An Open Label Exploratory Study to Assess the Safety, Tolerability and Clinical Activity of Topically Applied ESBA105 in Patients With Acute Anterior Uveitis
The purpose of this study is to determine whether ESBA105, a topically applied TNF-alpha inhibitor, is safe and clinically active when applied to the eye of patients suffering from acute anterior uveitis
Read the detailed description
Acute anterior uveitis (AAU) is a common, recurrent disease characterized by inflammation of the iris and ciliary body. Though usually effectively treated by topical corticosteroids, novel treatment modalities are required to overcome the limitations and adverse effect problems associated with the use of corticosteroids. TNF-alpha has been recognized as a central disease mediator in AAU, as shown by preclinical models and clinical data with systemically applied TNF-alpha inhibitors.
ESBA105 is a topically applied TNF-alpha inhibitor that is characterized by efficient penetration into the eye resulting in high intraocular drug levels. A recently completed Phase I trial confirmed that safety and tolerability of topical ESBA105 in healthy individuals is excellent and systemic exposure is low.
In this pilot trial, the safety, local tolerability and clinical activity of topical ESBA105 in the treatment of patients with acute anterior uveitis shall be explored.
- Conditions
- Anterior Uveitis
- Being tested
- ESBA105
- Keywords
- Uveitis, TNF-alpha, Topical, ESBA105, scFv antibody fragment, ocular inflammation
- Medical subject headings
- Uveitis, Anterior, Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESBA105Biological
ESBA105 eye drops (10mg/mL), initially applied in hourly dosing intervals, followed by later dose tapering (prolongation of dosing intervals)
| Study group | Role | What they receive |
|---|---|---|
| Topical ESBA105 | Experimental | ESBA105 applied as eye drops Receives: Biological: ESBA105 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the level of intraocular inflammation (anterior chamber cell count according to SUN Working group criteria)
Measured: 28 Days
Secondary outcomes (3)
Nature and incidence of adverse events, physical and ophthalmological findings and laboratory test results
Measured: 28 Days
Systemic exposure to study drug
Measured: 28 Days
Changes in disease severity as assessed by visual analogue scale (VAS)
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionDec 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 Anterior 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- ESBATech AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Manfred Zierhut, MD, Study chair, Universitäts-Augenklinik Tübingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00823173
- Sponsor's protocol ID
- ESBA105CRD04
- Status last verified
- Sep 2010
- First submitted
- 14 Jan 2009
- Last updated
- 26 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Exploratory Study to Assess the Safety, Tolerability and Clinical Activity of Topically Applied ESBA105 in Patients With Acute Anterior Uveitis
- ClinicalTrials.gov ID
- NCT00823173
- Acronym / sponsor ID
- ESBA105CRD04
- Conditions
- Anterior Uveitis
- Keywords
- Uveitis, TNF-alpha, Topical, ESBA105, scFv antibody fragment, ocular inflammation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- ESBATech AGIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 15 Jan 2009 (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 purpose of this study is to determine whether ESBA105, a topically applied TNF-alpha inhibitor, is safe and clinically active when applied to the eye of patients suffering from acute anterior uveitis
Detailed description
Acute anterior uveitis (AAU) is a common, recurrent disease characterized by inflammation of the iris and ciliary body. Though usually effectively treated by topical corticosteroids, novel treatment modalities are required to overcome the limitations and adverse effect problems associated with the use of corticosteroids. TNF-alpha has been recognized as a central disease mediator in AAU, as shown by preclinical models and clinical data with systemically applied TNF-alpha inhibitors.
ESBA105 is a topically applied TNF-alpha inhibitor that is characterized by efficient penetration into the eye resulting in high intraocular drug levels. A recently completed Phase I trial confirmed that safety and tolerability of topical ESBA105 in healthy individuals is excellent and systemic exposure is low.
In this pilot trial, the safety, local tolerability and clinical activity of topical ESBA105 in the treatment of patients with acute anterior uveitis shall be explored.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Topical ESBA105 | Experimental | Biological: ESBA105ESBA105 applied as eye drops |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed and dated informed consent.
- Patients with the typical presentation of HLA-B27 positive AAU (unilateral, painful anterior uveitis of sudden onset).
- 2+ anterior chamber cells according to the SUN Working Group criteria, as assessed by slit lamp biomicroscopy.
- Start of the typical first symptoms of the current attack, defined as the point in time when the patient felt the first sensation of the attack, within the last 72 hours before initiation of treatment with the study medication.
- Negative pregnancy test for females of childbearing potential (pre menopausal, <2 years post-menopausal, not surgically sterile).
Key exclusion criteria (19 listed)
- IOP elevation requiring therapy.
- Uncontrolled diabetes mellitus and diabetic retinopathy.
- Patients with a single eye or a pinhole Snellen visual acuity 20/200 or worse in the non study eye.
- Patients with 1+ or less anterior chamber cells.
- Patients with 3+ or 4+ anterior chamber cells or hypopyon.
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 |
|---|---|---|
| ESBA105ESBA105 eye drops (10mg/mL), initially applied in hourly dosing intervals, followed by later dose tapering (prolongation of dosing intervals) | Biological | Topical ESBA105 |
Primary outcome
Changes in the level of intraocular inflammation (anterior chamber cell count according to SUN Working group criteria)
Time frame: 28 Days
3 secondary outcomes
Nature and incidence of adverse events, physical and ophthalmological findings and laboratory test results
Time frame: 28 Days
Systemic exposure to study drug
Time frame: 28 Days
Changes in disease severity as assessed by visual analogue scale (VAS)
Time frame: 28 Days
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 26 May 2011.
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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.
Manfred Zierhut, MD study chair
Universitäts-Augenklinik Tübingen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ESBA105 in people with Anterior Uveitis, run by ESBATech AG at 3 sites 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 8 inclusion and 19 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 26 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Changes in the level of intraocular inflammation (anterior chamber cell count according to SUN Working group criteria) (time frame: 28 Days). 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 26 May 2011.