Combination of Standard Lucentis Therapy With Micropulse Diode Laser for the Treatment of Diabetic Macular Edema

Phase 4

• Conditions: Diabetic Macular Edema
• Interventions: Drug: ranibizumab; Procedure: micropulse diode laser

• Registration Number: NCT02059772
• Lead Sponsor: GWT-TUD GmbH

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-10
• Study First Submitted QC: 2014-02-10
• Study First Posted: 2014-02-11
• Study Start: 2014-04-30
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-21
• Last Update Posted: 2017-02-23
• Primary Completion: 2017-11
• Study Completion: 2017-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	micropulse diode laser	Combination of standard therapy of Lucentis (ranibizumab) according to SmPC and micropulse diode laser treatment
Control Group	ranibizumab	Standard therapy of diabetic macular edema with Lucentis (ranibizumab) according to SmPC
Treatment Group	ranibizumab	Combination of standard therapy of Lucentis (ranibizumab) according to SmPC and micropulse diode laser treatment

Primary Outcome Measures

Name	Time	Method
change in best corrected visual acuity (BCVA)	baseline, 12 month

Secondary Outcome Measures

Name	Time	Method
change in central macular thickness	baseline, 12 month
number of intravitreal Lucentis injections	within 12 month

Trial Locations

Locations (1)

Klinik für Augenheilkunde, Klinikum Chemnitz gGmbH; 🇩🇪 Chemnitz, Germany