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

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

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).

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