Überprüfung einer ergänzenden Therapie des diabetischen Makulaödems mit dem Diodenlaser zur Standardtherapie mit VEGF-Inhibitore
- Conditions
- visual impairment due to diabetic macular edemaMedDRA version: 18.0Level: LLTClassification code 10057934Term: Diabetic macular edemaSystem Organ Class: 100000004853Therapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2013-003056-21-DE
- Lead Sponsor
- GWT-TUD GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
- 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
- Laser therapy of study eye within the last 6 months
- Systemic steroid therapy within the last 3 month
- Uncontrolled blood sugar or blood pressure
- Pregnant or breast feeding woman and woman without adequate method of contraception
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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) as measured by best corrected visual acuity (BCVA)<br><br>;Secondary Objective: To evaluate the influence of a combination therapy of diabetic macular edema with micropulse diode laser and Lucentis® on central macular thickness measured by SD-OCT and<br>To evaluate the influence of a combination therapy of diabetic macular edema with micropulse diode laser and Lucentis® on number of treatments with Lucentis® in comparison to standard therapy (intravitreal injection of ranibizumab only);Primary end point(s): Best corrected visual acuity (BCVA);Timepoint(s) of evaluation of this end point: every 4 weeks for a total of 13 month
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Central macular thickness measured by SD-OCT<br>- Number of treatments with Lucentis;Timepoint(s) of evaluation of this end point: every 4 weeks for a total of 13 month