Efficacy, Safety and Tolerability of Repeated Dosis of Intravitreous Bevacizumab in Uveitic Macular Oedema

NCT ID: NCT01095809

Last Updated: 2012-03-23

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2013-04-30

Brief Summary

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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

Detailed Description

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Conditions

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Uveitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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bevacizumab

intravitreous bevacizumab 2,5 mg at baseline, week 4 and 8. reinjection is required.

Group Type EXPERIMENTAL

bevacizumab

Intervention Type DRUG

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

Group Type EXPERIMENTAL

triamcinolone acetonide

Intervention Type DRUG

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

Intervention Type DRUG

triamcinolone acetonide

2 mg at baseline; frequency every three months if needed. reinjection criteria are described in protocol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* previous thromboembolism or receiving oral anticoagulant treatment
* vitrectomy
* patients with proved tractional macular pathology associated to macular oedema
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Clinic of Barcelona

OTHER

Sponsor Role lead

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

Site Status

Hospital Santa creu i Sant Pau

Barcelona, Spain/ Catalonia, Spain

Site Status

Instituto Vissum Alicante

Alicante, Spain/ Com. Valenciana, Spain

Site Status

Hospital Vall d'Hebron

Barcelona, Spain/Catalonia, Spain

Site Status

Hospital Clinic of Barcelona

Barcelona, Spain/Catalonia, Spain

Site Status

Countries

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Spain

Other Identifiers

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EBEV

Identifier Type: -

Identifier Source: org_study_id

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