Trial document





This trial has been registered retrospectively.
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  DRKS00004918

Trial Description

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Title

Switch of anti-VEGF agents (Bevacizumab and Ranibizumab) in non-responders to anti-VEGF treatment in AMD

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This study inverstigates the clinical outcomes of patients who have been treated for AMD with intravitreal injections of an VEGF-inhibitor (bevacizumab or ranibizumab) and switched to the other after being defined as non-responders.

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Brief Summary in Scientific Language

retrospective analysis of clinical course and potential risk factors in non-responders to anti-VEGF treatment for AMD

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00004918
  •   2013/07/04
  •   [---]*
  •   yes
  •   Approved
  •   428/12, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   H35.3 -  Degeneration of macula and posterior pole
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Interventions/Observational Groups

  •   switch from intravitreal bevacizumab (at least 3 monthly injections) to 3 monthly injections of ranibizumab.
    No further data besides the clinical routine will be collected.
  •   switch from intravitreal ranibizumab (at least 3 monthly injections) to 3 monthly injections of bevacizumab.
    No further data besides the clinical routine will be collected.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

regression analysis to look for prognostic factors before and after switch of medication: age, injections before switch, medication before switch, visual acuity (5m distant VA) and retinal thickness (central macular thickness measured by OCT (optical coherence tomography)) at the time of switch

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Secondary Outcome

change of visual acuity (5m distance VA) and retinal thickness (central macular thickness measured by OCT) 4 weeks after 3 intravitreal injections after switching the medication

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2012/11/06
  •   435
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

intravitreal injections for treatment of AMD, switch of medication after at least 3 monthly injections to the other medication after max. 100 days, at least 3 monthly injections after switch, data available for visual acuity before,a fter, and at time of switch

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Exclusion Criteria

indications other than AMD, other reasons/comorbidity for impaired visual acuity, intraocular surgery during time of study, therapy regime other than mentioned under inclusion criteria, macular hemorrhage during time of study, missing data

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Addresses

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    • Universitäts-Augenklinik Freiburg
    • Killianstraße 5
    • 79106  Freiburg
    • Germany
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    • Universitäts-Augenklinik Freiburg
    • Mr.  Dr.  Christoph  Ehlken 
    • Killianstraße 5
    • 79106  Freiburg
    • Germany
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    • Universitäts-Augenklinik Freiburg
    • Mr.  Dr.  Christoph  Ehlken 
    • Killianstraße 5
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitäts-Augenklinik Freiburg
    • Killianstraße 5
    • 79106  Freiburg
    • Germany
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2012/11/30
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Trial Publications, Results and other Documents

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