This trial is active, not recruiting.

Condition diabetic macular edema
Treatments ranibizumab, micropulse diode laser
Phase phase 4
Target VEGF
Sponsor GWT-TUD GmbH
Collaborator Novartis
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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Standard therapy of diabetic macular edema with Lucentis (ranibizumab) according to SmPC
ranibizumab Lucentis
Combination of standard therapy of Lucentis (ranibizumab) according to SmPC and micropulse diode laser treatment
ranibizumab Lucentis
micropulse diode laser

Primary Outcomes

change in best corrected visual acuity (BCVA)
time frame: baseline, 12 month

Secondary Outcomes

change in central macular thickness
time frame: baseline, 12 month
number of intravitreal Lucentis injections
time frame: within 12 month

Eligibility Criteria

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by GWT-TUD GmbH.