Trial document



drksid header

  DRKS00006851

Trial Description

start of 1:1-Block title

Title

Correlation of subjective visual parameters with morphologic parameters in reactivation of exsudative maculopathies

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

[---]*

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Different exsudative diseases of the macula (e.g. age related maculopathy (AMD), diabetic macular edema (DME), macular edema in retinal vein occlusion (RVO), myopic choroidal neovascularisation (CNV)) are currently treated by intravitreal injection of VEGF inhibitors. The official recommendations of the german ophthalmological associations (DOG, BVA, RG) include that affected patients shall be controlled in monthly intervals after the end of treatment. These controls require a high logistic support for both patients and examiner (time, transport, devices). The aim of this study is to investigate wether subjective parameters (estimation of the visual acuity and the metamorphopsia) can help to detect reliably a reactivation of disease. For this purpose we plan to compare the current gold standard of clinical examination (visual acuity, morphologic examination with the optical coherence tomography (OCT)) with the above-named subjective parameters. We try to identify patient groups in which the control interval might be adapted. Different diseases (AMD, DME, RVO, myopic CNV) shall be analyzed. In a second step the correlation between subjecitve parameters and morphologic parameters shall be investigated.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00006851
  •   2014/10/09
  •   [---]*
  •   yes
  •   Approved
  •   413/14, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   H35.3 -  Degeneration of macula and posterior pole
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   non-interventional study
    retrospective data analysis of all patients who were examined in the clinical "IVOM-OCT-consultation" (clinical control of the success of treatment about 8 weeks after the last intravitreal injection, 4 weeks after the first control of success). If several appointments in the "IVOM-OCT-consultation" have taken place only the first documented appointment will be analysed (analysis of the documented subjective
    estimation of visual acuity and metamorphopsia, analysis of the documented visual acuity, analysis of the executed OCT)
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

specificity and sensitivity of subjective parameter (e.g. visual acuity, metamorphopsia; evaluation of the subjective devolopment as defined by better / worse / equal) in the evaluation of activity of maculopathy in age related maculopathy, retinal vein occlusion, diabetic retinopathy and other maculopathies

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Differences in specificity and sensitivity of the above-named parameter in different diseases, identification of characteristics of the morphology in reactivated disease, correlation of these characteristics with subjective parameter, correlation with basic data (eye function, age)

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2014/10/15
  •   1200
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

first examination of patients with maculopathy (age related maculopathy, diabetes, retinal vein occlusion, myopia, other diseases with development of choroidal neovascularisation) having received intravitreal injections with anti-VEGF (bevacizumab, ranibizumab, aflibercept) who were adjudged to be not in need of further treatment and were appointed to control examinations in the "IVOM-OCT-Sprechstunde"

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

examination other than primary examination, other interventions (e.g. injection of TAC, Jetrea, Ozurdex), surgery of the study eye in the intervall between last intravitreal injection and OCT control

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für AugenheilkundeUniversitätsklinikum Freiburg
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Klinik für AugenheilkundeUniversitätsklinikum Freiburg
    • Mr.  Dr.  Christoph  Ehlken 
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Klinik für AugenheilkundeUniversitätsklinikum Freiburg
    • Mr.  Dr.  Christoph  Ehlken 
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Klinik für AugenheilkundeUniversitätsklinikum Freiburg
    • Mr.  Dr.  Christoph  Ehlken 
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Klinik für AugenheilkundeUniversitätsklinikum Freiburg
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.