Efficacy, Safety and Tolerability of Repeated Dosis of Intravitreous Bevacizumab in Uveitic Macular Oedema
NCT ID: NCT01095809
Last Updated: 2012-03-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
5 participants
INTERVENTIONAL
2010-04-30
2013-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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bevacizumab
intravitreous bevacizumab 2,5 mg at baseline, week 4 and 8. reinjection is required.
bevacizumab
2.5mg at baseline, week 4 and 8. Beyond this initial period if needed reinjection criteria are described in protocol
triamcinolone acetonide
intravitreous triamcinolone 2 mg, frequency: 3 months
triamcinolone acetonide
2 mg at baseline; frequency every three months if needed. reinjection criteria are described in protocol
Interventions
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bevacizumab
2.5mg at baseline, week 4 and 8. Beyond this initial period if needed reinjection criteria are described in protocol
triamcinolone acetonide
2 mg at baseline; frequency every three months if needed. reinjection criteria are described in protocol
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* previous thromboembolism or receiving oral anticoagulant treatment
* vitrectomy
* patients with proved tractional macular pathology associated to macular oedema
18 Years
ALL
No
Sponsors
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Hospital Clinic of Barcelona
OTHER
Responsible Party
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Hospital Clinic of Barcelona
Locations
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Hospital de Son Dureta
Palma de Mallorca, Spain/ Baleares, Spain
Hospital Santa creu i Sant Pau
Barcelona, Spain/ Catalonia, Spain
Instituto Vissum Alicante
Alicante, Spain/ Com. Valenciana, Spain
Hospital Vall d'Hebron
Barcelona, Spain/Catalonia, Spain
Hospital Clinic of Barcelona
Barcelona, Spain/Catalonia, Spain
Countries
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Other Identifiers
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EBEV
Identifier Type: -
Identifier Source: org_study_id
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