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Clinical Trials/EUCTR2013-003056-21-DE
EUCTR2013-003056-21-DE
Active, not recruiting
Phase 1

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 - ReCa

GWT-TUD GmbH0 sitesDecember 18, 2013

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
visual impairment due to diabetic macular edema
Sponsor
GWT-TUD GmbH
Status
Active, not recruiting
Last Updated
9 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 18, 2013
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Patients at least 18 years with DME and 0\.05 \< BCVA \< 0\.6 or retinal thickness \>300 µm (determined by SD\-OCT)
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1\.2 Adults (18\-64 years) yes
  • F.1\.2\.1 Number of subjects for this age range 30
  • F.1\.3 Elderly (\>\=65 years) yes
  • F.1\.3\.1 Number of subjects for this age range 20

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 visual (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

Outcomes

Primary Outcomes

Not specified

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