Uveitis, IntermediatePhase 3NCT00344253
Randomized, Controlled Trial to Test the Efficacy of Interferon Beta in the Treatment of Intermediate Uveitis
A Phase 3 study testing Interferon beta and Methotrexate in people with Uveitis, Intermediate and Macular Edema, run by Heidelberg University at 1 site in Germany.
Trial summary
The purpose of this study is to investigate if interferon beta is superior to the standard treatment with Methotrexate for the treatment of intermediate uveitis and macular edema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitis, Intermediate, Macular Edema, Multiple Sclerosis
- What is being tested?
- Interferon beta and Methotrexate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2006to Jan 2012
- Phase
- Phase 3
- 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
- Male and female patients age 18 and over
- Active uni- or bilateral non-infectious intermediate uveitis of at least 1 year duration
- Visual acuity on the worse eye at least 0.1 (20/200) and maximally 0.6 (20/30) caused by macular edema, defined by foveal thickness ≥ 250 µm
- Either primary uveitis or diagnosis of Multiple Sclerosis
- Previous treatment with oral corticosteroids in a dose of 0.5 mg per kg bodyweight of prednisone equivalent without sufficient success
- Previous treatment with other immunosuppressive drugs is facultative
Who cannot join
- Exclusively anterior uveitis
- Absence of macular edema
- Optic nerve atrophy after neuritis nervi optici
- Peri-or intraocular injection of corticosteroids in the previous 3 months
- Allergies against any interferon
- Depression diagnosed by a psychiatrist
Show all 17Show fewer
- Hepatic disease
- Infectious Uveitis
- Other auto-immune diseases but MS
- Pregnancy, Lactation
- Lack of reliable contraception
- Patients with metabolic, psychiatric or neoplastic diseases
- Active diseases like asthma, psoriasis or inflammatory bowel disease who have to be treated with corticosteroids
- primary or secondary immune deficiency
- Tuberculosis or other infectious lung diseases
- Hepatitis B or C
- Life vaccination during the trial duration
Trial locations and contacts
1 site in 1 country.
Germany1 site
Interdisciplinary Uveitis Center, University of Heidelberg
Heidelberg, 69120
About this study
Official title: A Monocentric, Randomized, Controlled Trial to Test the Efficacy of Interferon-beta in the Treatment of Disseminated Encephalomyelitis (ED)-Associated and Primary Intermediate Uveitis in Comparison to Standard Treatment (TEAM)
The purpose of this study is to investigate if interferon beta is superior to the standard treatment with Methotrexate for the treatment of intermediate uveitis and macular edema.
Read the detailed description
Deuter et al were the first to show the anti-edematous effect of interferon alpha on inflammatory macular edema (Deuter C. M. E., Kötter I., Günaydin I., Zierhut M. Treatment of the Cystoid Macular Oedema in Behçet's Disease with Interferon Alfa-2a, Retina, in press). In an interventional, multi-centric pilot-study we could demonstrate a positive effect of interferon beta on ED associated uveitis, especially in reducing the macular edema. Undesired effects of the treatment were not observed.
Thus we want to test the efficacy and safety of interferon beta compared to standard treatment with methotrexate in a prospective, clinically controlled trial on patients who suffer from intermediate uveitis with inflammatory macular edema who either have associated ED or have no systemic disease association, i.e. primary uveitis. .
- Conditions
- Uveitis, Intermediate, Macular Edema, Multiple Sclerosis
- Being tested
- Interferon beta, Methotrexate
- Keywords
- Uveitis, Macular Edema, Interferon, Multiple Sclerosis, Encephalomyelitis disseminata (ED)
- Medical subject headings
- Uveitis, Intermediate, Macular Edema, Multiple Sclerosis, Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon betaDrug
MethotrexateDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Interferon beta 3x weekly Receives: Drug: Interferon beta |
| 2 | Active comparator | Methotrexate sc 20 mg weekly Receives: Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in visual acuity (3 lines ETDRS)at month 1,3,6 and 12
Measured: at month 1,3,6 and 12
Secondary outcomes (3)
Reduction of macular edema (OCT)
Measured: at month 1,3,6 and 12
Reduction intraocular inflammation (2 step change, SUN classification)
Measured: at month 1,3,6 and 12
Increase in retinal light sensitivity (fundus controlled perimetry)
Measured: at month 1,3 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2006 (estimated)
- Study startMar 2006
- Primary completionMar 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uveitis, IntermediateStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- Serono GmbH
- Responsible party
- Principal investigator, Friederike Mackensen, Heidelberg University
- Investigators
- Matthias D Becker, MD, PhD,FEBO, Principal investigator, Interdisciplinary Uveitis Center, University of HeidelbergFriederike Mackensen, MD, FEBO, Principal investigator, Interdisciplinary Uveitis Center,University of HeidelbergRegina Max, MD, Study director, Interdisciplinary Uveitis Center,University of Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00344253
- Sponsor's protocol ID
- EudraCT-Number: 2004-004403-37
- Status last verified
- Nov 2012
- First submitted
- 22 Jun 2006
- Last updated
- 3 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Becker MD, Heiligenhaus A, Hudde T, Storch-Hagenlocher B, Wildemann B, Barisani-Asenbauer T, Thimm C, Stubiger N, Trieschmann M, Fiehn C. Interferon as a treatment for uveitis associated with multiple sclerosis. Br J Ophthalmol. 2005 Oct;89(10):1254-7. doi: 10.1136/bjo.2004.061119.
PubMed 16170111
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Monocentric, Randomized, Controlled Trial to Test the Efficacy of Interferon-beta in the Treatment of Disseminated Encephalomyelitis (ED)-Associated and Primary Intermediate Uveitis in Comparison to Standard Treatment (TEAM)
- ClinicalTrials.gov ID
- NCT00344253
- Acronym / sponsor ID
- EudraCT-Number: 2004-004403-37
- Conditions
- Uveitis, Intermediate, Macular Edema, Multiple Sclerosis
- Keywords
- Uveitis, Macular Edema, Interferon, Multiple Sclerosis, Encephalomyelitis disseminata (ED)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- Serono GmbH
- Study start
- Mar 2006
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 26 Jun 2006 (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 investigate if interferon beta is superior to the standard treatment with Methotrexate for the treatment of intermediate uveitis and macular edema.
Detailed description
Deuter et al were the first to show the anti-edematous effect of interferon alpha on inflammatory macular edema (Deuter C. M. E., Kötter I., Günaydin I., Zierhut M. Treatment of the Cystoid Macular Oedema in Behçet's Disease with Interferon Alfa-2a, Retina, in press). In an interventional, multi-centric pilot-study we could demonstrate a positive effect of interferon beta on ED associated uveitis, especially in reducing the macular edema. Undesired effects of the treatment were not observed.
Thus we want to test the efficacy and safety of interferon beta compared to standard treatment with methotrexate in a prospective, clinically controlled trial on patients who suffer from intermediate uveitis with inflammatory macular edema who either have associated ED or have no systemic disease association, i.e. primary uveitis. .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Interferon betaInterferon beta 3x weekly |
| 2 | Active comparator | Drug: MethotrexateMethotrexate sc 20 mg weekly |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female patients age 18 and over
- Active uni- or bilateral non-infectious intermediate uveitis of at least 1 year duration
- Visual acuity on the worse eye at least 0.1 (20/200) and maximally 0.6 (20/30) caused by macular edema, defined by foveal thickness ≥ 250 µm
- Either primary uveitis or diagnosis of Multiple Sclerosis
- Previous treatment with oral corticosteroids in a dose of 0.5 mg per kg bodyweight of prednisone equivalent without sufficient success
Key exclusion criteria (17 listed)
- Exclusively anterior uveitis
- Absence of macular edema
- Optic nerve atrophy after neuritis nervi optici
- Peri-or intraocular injection of corticosteroids in the previous 3 months
- Allergies against any interferon
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 |
|---|---|---|
| Interferon beta | Drug | 1 |
| Methotrexate | Drug | 2 |
Primary outcome
Change in visual acuity (3 lines ETDRS)at month 1,3,6 and 12
Time frame: at month 1,3,6 and 12
3 secondary outcomes
Reduction of macular edema (OCT)
Time frame: at month 1,3,6 and 12
Reduction intraocular inflammation (2 step change, SUN classification)
Time frame: at month 1,3,6 and 12
Increase in retinal light sensitivity (fundus controlled perimetry)
Time frame: at month 1,3 and 12
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 3 Dec 2012.
- Background: PubMed 16170111Becker MD, Heiligenhaus A, Hudde T, Storch-Hagenlocher B, Wildemann B, Barisani-Asenbauer T, Thimm C, Stubiger N, Trieschmann M, Fiehn C. Interferon as a treatment for uveitis associated with multiple sclerosis. Br J Ophthalmol. 2005 Oct;89(10):1254-7. doi: 10.1136/bjo.2004.061119.
- Homepage with further information and downloadsLink provided by the sponsor.
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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.
Matthias D Becker, MD, PhD,FEBO principal investigator
Interdisciplinary Uveitis Center, University of Heidelberg
Friederike Mackensen, MD, FEBO principal investigator
Interdisciplinary Uveitis Center,University of Heidelberg
Regina Max, MD study director
Interdisciplinary Uveitis Center,University of Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Interferon beta and Methotrexate in people with Uveitis, Intermediate and Macular Edema, run by Heidelberg University 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 17 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 3 Dec 2012. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change in visual acuity (3 lines ETDRS)at month 1,3,6 and 12 (time frame: at month 1,3,6 and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00344253, which also lists 1 linked publication.
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 3 Dec 2012; AzTrials last refreshed its copy on 31 Oct 2026.