Trial document




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  DRKS00007999

Trial Description

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Title

Retrospective analysis of treatment with intravitreal injections in patients with AMD, DME and RVO in clinical practice

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Different pathologies of the macula, such as age-related macular degeneration (AMD), diabetic macular edema (DME) or macular edema secondary to retinal vein occlusion (RVO), are treated with intravitreal injections of VEGF-inhibitors. Re-treatment after the initial injections is based on evaluations of visual acuity, fundoscopy, fluorescence angiography, and optical coherence tomography (OCT). However, clinical results under real-life conditions are often inferior to those presented in the phase III trials with a strict control regimen. We would like to compare our real-life results with those in clinical studies, especially concerning VA, number of injections, injection free intervals, and drop-outs, in a retrospective study.

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Brief Summary in Scientific Language

Background: Different pathologies of the macula, such as age-related macular degeneration (AMD), diabetic macular edema (DME) or macular edema secondary to retinal vein occlusion (RVO), are treated with intravitreal injections (IVI) of VEGF-inhibitors. Re-treatment after the initial injections is based on evaluations of visual acuity, fundoscopy, fluorescence angiography, and optical coherence tomography (OCT). However, clinical results under real-life conditions, as seen in phase IV studies for wet AMD (WAVE, PONS, Lumiere) are often inferior to those presented in the phase III trials with a strict control regimen.
Purpose: to compare real-life results of patients treated and monitored within specialized outpatient clinics ("IVOM-Kontrollsprechstunde" with monthly examinations or injections) in the University Eye Hospital, Freiburg,Germany, with those in clinical phase III and IV studies.
Methods: retrospective analysis of patients recruited from our outpatients clinic. Patients who received IVI from the abovementioned diseases are eligible. Patients with comorbidities affecting VA or distribution of medication (e.g. after vitrectomy) are excluded. Parameters are visual acuity (VA), proportion of patients with stable VA (loss <15 letters), number of injections, injection free intervals, and drop-outs within 12/24/36 months.

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Organizational Data

  •   DRKS00007999
  •   2015/04/08
  •   [---]*
  •   yes
  •   Approved
  •   412/14, 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
  •   H34.8 -  Other retinal vascular occlusions
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Interventions/Observational Groups

  •   Treatment of patients with AMD, DME, or RVO, with anti-VEGF agents (Avastin, Lucentis, Eylea), according to the official guidelines by DOG (Deutsche Ophthalmologische Gesellschaft), RG (Retinologische Gesellschaft), and BVA (Bundesverband Deutscher Augenärzte).
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Health care system
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

proportion of patients with loss of <15 letters visual acuity after 12 months

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Secondary Outcome

change of visual acuity (VA) within 12/24/36 months
proportion of patients with a) loss of <15 letters after 24/36 months
b) gain of at least 15 letters after 12/24/36 months
descriptive statistics:
number of injections within up to 36 months
rate of injections-free intervals of at least 6/8/12 weeks
proportion of patients with active disease or under regular control examinations after 12/24/36 months
test for differences between the aforementioned indications (AMD; DME; RVO)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/04/08
  •   1800
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

patients receiving intravitreal injections of anti-VEGF for AMD, DME, or RVO
patients who were monitored in our IVOM-outpatients clinic and who received their first injection at least 12 months ago
informed consent

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Exclusion Criteria

VA-limiting ocular comorbidity (such as other maculopathies, advanced or uncontrolled glaucoma). Vitrectomy in patient history in study eye. VA-relevant surgery during study (such as cataract surgery).

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Addresses

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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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    • 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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    • Zentrum für AugenheilkundeUniversität Freiburg
    • Mr.  Dr.   Christoph  Ehlken 
    • Killianstrasse 5
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.