UveitisPhase 3EBEVNCT01095809
Efficacy, Safety and Tolerability of Repeated Dosis of Intravitreous Bevacizumab in Uveitic Macular Oedema
A Phase 3 study testing bevacizumab and triamcinolone acetonide in people with Uveitis, run by Hospital Clinic of Barcelona at 5 sites in Spain.
Trial summary
The purpose of this study is to determine whether intravitreous bevacizumab or intravitreous triamcinolone acetonide are effective and safe in the treatment of uveitic macular oedema Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitis
- What is being tested?
- bevacizumab and triamcinolone acetonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 5 sitesSpain
- Study dates
- Apr 2010to Apr 2013
- 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
- adult patients with uveitis or retinal vasculitis with unilateral or bilateral macular oedema
- with macular thickness > 250 micra using OCT
- visual acuity at least 20/200
- with stable treatment with oral prednisone at least during 3 months, either oral ciclosporin or other immunomodulator to treat intraocular inflammatory disease
- patient that can follow study's requirements
- patient who consents to participate
Who cannot join
- presence of corneal or crystalline opacity preventing observation of fundus of eye
- patients requiring ocular surgery in next 3 months
- one-eyed
- pregnancy and child breastfeeding
- previous history of glaucoma
- on treatment woth an experimental ocular drug
Show all 9Show fewer
- previous thromboembolism or receiving oral anticoagulant treatment
- vitrectomy
- patients with proved tractional macular pathology associated to macular oedema
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Instituto Vissum Alicante
Alicante, Spain/ Com. Valenciana, 03016
Hospital Santa creu i Sant Pau
Barcelona, Spain/ Catalonia, 08025
Hospital Vall d'Hebron
Barcelona, Spain/Catalonia, 08035
Hospital Clinic of Barcelona
Barcelona, Spain/Catalonia, 08036
Hospital de Son Dureta
Palma de Mallorca, Spain/ Baleares, 07014
About this study
Official title: Open , Randomized Study About Efficacy, Safety and Tolerability od Repeated Dosis of Intravitreous Bevacizumab in Patients With Uveitic Macular Oedema
The purpose of this study is to determine whether intravitreous bevacizumab or intravitreous triamcinolone acetonide are effective and safe in the treatment of uveitic macular oedema
- Conditions
- Uveitis
- Being tested
- bevacizumab, triamcinolone acetonide
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumabDrug
2.5mg at baseline, week 4 and 8. Beyond this initial period if needed reinjection criteria are described in protocol
triamcinolone acetonideDrug
2 mg at baseline; frequency every three months if needed. reinjection criteria are described in protocol
| Study group | Role | What they receive |
|---|---|---|
| bevacizumab | Experimental | intravitreous bevacizumab 2,5 mg at baseline, week 4 and 8. reinjection is required. Receives: Drug: bevacizumab |
| triamcinolone acetonide | Experimental | intravitreous triamcinolone 2 mg, frequency: 3 months Receives: Drug: triamcinolone acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular Thickness Measurements Using Stratus Optical Coherence Tomography
Measured: 48 weeks
Secondary outcomes (3)
visual acuity
Measured: 48 weeks
intraocular pressure
Measured: 48 weeks
opacity crystalline
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2013 (estimated)
- Study completionApr 2013 (estimated)
Why it stopped: New intraocular steroid in the market. Recruitment no longer ethical.
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.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01095809
- Sponsor's protocol ID
- EBEV
- Acronym
- EBEV
- Status last verified
- Dec 2010
- First submitted
- 29 Mar 2010
- Last updated
- 23 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open , Randomized Study About Efficacy, Safety and Tolerability od Repeated Dosis of Intravitreous Bevacizumab in Patients With Uveitic Macular Oedema
- ClinicalTrials.gov ID
- NCT01095809
- Acronym / sponsor ID
- EBEV / EBEV
- Conditions
- Uveitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: New intraocular steroid in the market. Recruitment no longer ethical.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 30 Mar 2010 (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 intravitreous bevacizumab or intravitreous triamcinolone acetonide are effective and safe in the treatment of uveitic macular oedema
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bevacizumab | Experimental | Drug: bevacizumabintravitreous bevacizumab 2,5 mg at baseline, week 4 and 8. reinjection is required. |
| triamcinolone acetonide | Experimental | Drug: triamcinolone acetonideintravitreous triamcinolone 2 mg, frequency: 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- adult patients with uveitis or retinal vasculitis with unilateral or bilateral macular oedema
- with macular thickness > 250 micra using OCT
- visual acuity at least 20/200
- with stable treatment with oral prednisone at least during 3 months, either oral ciclosporin or other immunomodulator to treat intraocular inflammatory disease
- patient that can follow study's requirements
Key exclusion criteria (9 listed)
- presence of corneal or crystalline opacity preventing observation of fundus of eye
- patients requiring ocular surgery in next 3 months
- one-eyed
- pregnancy and child breastfeeding
- previous history of glaucoma
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 |
|---|---|---|
| bevacizumab2.5mg at baseline, week 4 and 8. Beyond this initial period if needed reinjection criteria are described in protocol | Drug | bevacizumab |
| triamcinolone acetonide2 mg at baseline; frequency every three months if needed. reinjection criteria are described in protocol | Drug | triamcinolone acetonide |
Primary outcome
Macular Thickness Measurements Using Stratus Optical Coherence Tomography
Time frame: 48 weeks
3 secondary outcomes
visual acuity
Time frame: 48 weeks
intraocular pressure
Time frame: 48 weeks
opacity crystalline
Time frame: 48 weeks
Results and safety
The study was stopped early (reason given: New intraocular steroid in the market. Recruitment no longer ethical.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bevacizumab and triamcinolone acetonide in people with Uveitis, run by Hospital Clinic of Barcelona at 5 sites in Spain.
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: stopped early, as of the sponsor's last update on 23 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. 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 was stopped early (reason given: New intraocular steroid in the market. Recruitment no longer ethical.). 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?
Macular Thickness Measurements Using Stratus Optical Coherence Tomography (time frame: 48 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 23 Mar 2012.