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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Diabetic Macular Edema

Intervention / Treatment
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* Drug: ranibizumab
* Procedure: micropulse diode laser


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control Group<br>Standard therapy of diabetic macular edema with Lucentis (ranibizumab) according to SmPC | Drug: ranibizumab<br> <br> * Other names: Lucentis;|
| Experimental: Treatment Group<br>Combination of standard therapy of Lucentis (ranibizumab) according to SmPC and micropulse diode laser treatment | Drug: ranibizumab<br> <br> * Other names: Lucentis;Procedure: micropulse diode laser<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in best corrected visual acuity (BCVA) |  | baseline, 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in central macular thickness |  | baseline, 12 month | 
| number of intravitreal Lucentis injections |  | within 12 month |