Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005855

Trial Description

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Title

Evaluation of an Additional Therapeutic Approach to Diabetic Macular Edema by Combining Standard Therapy (Intravitreal Injection of a VEGF-inhibitor) With Micropulse Diode Laser Treatment in a Randomized, Controlled Proof of Concept Study

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Trial Acronym

ReCaLL

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URL of the Trial

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Brief Summary in Lay Language

The primary objective of this study is to evaluate if a combination therapy with micropulse
diode laser treatment shows non inferiority on visual acuity within 12 months in comparison
to standard therapy (intravitreal injection of ranibizumab only).

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Brief Summary in Scientific Language

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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

  •   DRKS00005855
  •   2015/02/19
  •   2014/02/10
  •   no
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Secondary IDs

  •   NCT02059772  (ClinicalTrials.gov)
  •   ReCaLL-2013  (GWT-TUD GmbH)
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Health Condition or Problem studied

  •   Diabetic Macular Edema
  •   H36.0 -  Diabetic retinopathy
  •   E10-E14 -  Diabetes mellitus
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Interventions/Observational Groups

  •   Drug: ranibizumab
  •   Procedure: micropulse diode laser
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Treatment
  •   Parallel
  •   IV
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Primary Outcome

- change in best corrected visual acuity (BCVA); time frame: baseline, 12 month

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Secondary Outcome

- change in central macular thickness; time frame: baseline, 12 month
- number of intravitreal Lucentis injections; time frame: within 12 month

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2014/03/31
  •   50
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Inclusion Criteria

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

- Diagnosis of non-ischemic diabetic macular edema with resulting reduction in visual
functionality by determination of best corrected visual acuity (BCVA), ophthalmologic
investigation, SD-OCT, FAG and anamnesis

- BCVA between 0.05 and 0.6 or retinal thickness > 300 µm determined by SD-OCT

- The informed consent form must be signed before any study specific tests or
procedures are done

- Confirmation of the subject's health insurance coverage prior to the first screening
visit

- Age at least 18 years (inclusive) at the first screening visit

- Ability to understand and follow study-related instructions

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Exclusion Criteria

- Severe ischemic maculopathy of the study eye

- Active neovascularization of iris or retina in the study eye

- History of intravitreal injection of VEGF-inhibitor or steroids in study eye within
the last 3 month

- Pathologies of the anterior segment of the study eye with reduced visual acuity (e.g.
corneal opacification, advanced cataract)

- Advanced glaucoma with central defects of the visual field in study eye

- Retinal pathologies with reduced visus (e.g. central scars, age related macular
degeneration) in study eye

- Retinal vascular occlusion in medical history of study eye

- Active or suspected ocular or periocular infections

- Active intraocular inflammation in study eye

- Intraocular surgery of study eye within the last 6 months

- Laser therapy of study eye within the last 6 months

- Systemic steroid therapy within the last 3 month

- HbA1c >10%

- Systolic blood pressure above 170 mmHg and diastolic blood pressure above 110 mmHg
(after at least 3 min in supine position)

- Pregnant or breast-feeding woman and woman without adequate method of contraception.

- Known hypersensitivity to the active substance or to any of the excipients

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Addresses

  • start of 1:1-Block address primary-sponsor
    • GWT-TUD GmbH
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    • Novartis
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    • Klinik für Augenheilkunde, Klinikum Chemnitz gGmbH
    • Klio Ai Becker, MD 
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    • Klio Ai Becker, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/02/23
* This entry means the parameter is not applicable or has not been set.