Überprüfung einer ergänzenden Therapie des diabetischen Makulaödems mit dem Diodenlaser zur Standardtherapie mit VEGF-Inhibitoren

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 - ReCaLL

Status

Active, not recruiting

Phases

Phase 2Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003056-21-DE

Enrollment

Unknown

Registered

2013-12-18

Start date

2014-03-19

Completion date

Unknown

Last updated

2017-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

visual impairment due to diabetic macular edema MedDRA version: 18.0 Level: LLT Classification code 10057934 Term: Diabetic macular edema System Organ Class: 100000004853

Interventions

Trade Name: Lucentis Product Name: Lucentis Pharmaceutical Form: Solution for injection Trade Name: Lucentis Product Name: Lucentis Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients at least 18 years with DME and 0.05 300 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

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 - 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

Design outcomes

Primary

Measure	Time frame
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) ;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 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	—

Measure

Time frame

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) ;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 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

Measure	Time frame
Secondary end point(s): - Central macular thickness measured by SD-OCT - Number of treatments with Lucentis;Timepoint(s) of evaluation of this end point: every 4 weeks for a total of 13 month	—

Countries

Germany

Contacts

Public ContactMedical Consulting

GWT-TUD GmbH

medical.consulting@gwtonline.de004935125933189

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026