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

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ClinicalTrials.gov Identifier: NCT01095809
Recruitment Status : Terminated (New intraocular steroid in the market. Recruitment no longer ethical.)
First Posted : March 30, 2010
Last Update Posted : March 23, 2012
Sponsor:
Information provided by:
Hospital Clinic of Barcelona

Brief 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

Condition or disease Intervention/treatment Phase
Uveitis Drug: bevacizumab Drug: triamcinolone acetonide Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open , Randomized Study About Efficacy, Safety and Tolerability od Repeated Dosis of Intravitreous Bevacizumab in Patients With Uveitic Macular Oedema
Study Start Date : April 2010
Estimated Primary Completion Date : April 2013
Estimated Study Completion Date : April 2013


Arm Intervention/treatment
Experimental: bevacizumab
intravitreous bevacizumab 2,5 mg at baseline, week 4 and 8. reinjection is required.
Drug: bevacizumab
2.5mg at baseline, week 4 and 8. Beyond this initial period if needed reinjection criteria are described in protocol

Experimental: triamcinolone acetonide
intravitreous triamcinolone 2 mg, frequency: 3 months
Drug: triamcinolone acetonide
2 mg at baseline; frequency every three months if needed. reinjection criteria are described in protocol




Primary Outcome Measures :
  1. Macular Thickness Measurements Using Stratus Optical Coherence Tomography [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  1. visual acuity [ Time Frame: 48 weeks ]
  2. intraocular pressure [ Time Frame: 48 weeks ]
  3. opacity crystalline [ Time Frame: 48 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01095809


Locations
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Spain
Hospital de Son Dureta
palma de Mallorca, Spain/ Baleares, Spain, 07014
Hospital Santa creu i Sant Pau
Barcelona, Spain/ catalonia, Spain, 08025
Instituto Vissum Alicante
Alicante, Spain/ Com. Valenciana, Spain, 03016
Hospital Vall d'Hebron
Barcelona, Spain/Catalonia, Spain, 08035
Hospital Clinic of Barcelona
Barcelona, Spain/Catalonia, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona

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Responsible Party: Alfredo Manuel Adan Civera, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT01095809     History of Changes
Other Study ID Numbers: EBEV
First Posted: March 30, 2010    Key Record Dates
Last Update Posted: March 23, 2012
Last Verified: December 2010

Additional relevant MeSH terms:
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Macular Edema
Uveitis
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Uveal Diseases
Bevacizumab
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action