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
Conditionsvisual impairment due to diabetic macular edemaMedDRA version: 18.0Level: LLTClassification code 10057934Term: Diabetic macular edemaSystem Organ Class: 100000004853Therapeutic area: Diseases [C] - Eye Diseases [C11]
DrugsLucentis
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.
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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