Combination of Standard Lucentis Therapy With Micropulse Diode Laser for the Treatment of Diabetic Macular Edema
This trial is active, not recruiting.
|Condition||diabetic macular edema|
|Treatments||ranibizumab, micropulse diode laser|
|Start date||April 2014|
|End date||June 2016|
|Trial size||25 participants|
|Trial identifier||NCT02059772, ReCaLL-2013|
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).
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
change in best corrected visual acuity (BCVA)
time frame: baseline, 12 month
change in central macular thickness
time frame: baseline, 12 month
number of intravitreal Lucentis injections
time frame: within 12 month
Male or female participants at least 18 years old.
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
|Official title||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|
Call for more information