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

• Status: Unknown status
• Trial end date: 2017-12-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GWT-TUD GmbH
• Collaborator: Novartis
• Treatments: Ranibizumab

Criteria

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