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

Sponsor
Hospital Clinic of Barcelona
Study ID
NCT01095809
Phase
PHASE3
Status
Terminated

Conditions

  • Uveitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — DRUG
    2.5mg at baseline, week 4 and 8. Beyond this initial period if needed reinjection criteria are described in protocol
  • triamcinolone acetonide — DRUG
    2 mg at baseline; frequency every three months if needed. reinjection criteria are described in protocol

Study Details

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

Key Dates

First listed
Mar 30, 2010
Start date
Apr 30, 2010
Status verified
Dec 2010
Primary completion
Apr 30, 2013
Completion
Apr 30, 2013

Study Design

Enrollment
5 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: bevacizumab
    intravitreous bevacizumab 2,5 mg at baseline, week 4 and 8. reinjection is required.
  • Experimental: triamcinolone acetonide
    intravitreous triamcinolone 2 mg, frequency: 3 months

Primary Outcome Measure

Macular Thickness Measurements Using Stratus Optical Coherence Tomography [ Time Frame: 48 weeks ]

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