Patients with macular edema due to diabetic retinopathy MedDRA version: 12.1 Level: LLT Classification code 10060837 Term: Choroidal neovascularization
Conditions
Interventions
Trade Name: Lucentis 10 mg/ml
Pharmaceutical Form: Solution for injection
Sponsors
Department of Ophthalmology, Hietzing Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria - Signed informed consent - Age> = 18 years - Patients with type 1 or 2 diabetes mellitus - Patients with diabetic macular edema with center involvement - Central macular thickness (macular edema) of at least 300 microns in the central subfield as measured by OCT - Best corrected visual acuity, using ETDRS charts; of 78 (20/32) to 24 (20/320) in the study eye Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - A condition that would preclude the patient for participation in the study in opinion of investigator, e.g., unstable blood pressure(systolic > 180, diastolic > 110) and unstable glycemic control (Hb1Ac levels > = 9% or recent change in glycamic therapy to intensive Insulin treatment within the past 6 months). - Pregnency or nursing - History of previous heart attack or stroke within the past 6 months - History of allergic reaction to treatment with Ranibizumab - Glaucoma patients with unstable intraocular pressure (> 25 mmHg) Prior/Concomitant treatment in study eye - Macular laser photocoagulation or intravitreal treatment within the past 3 months - Panretinal laser photocoagulation within the past 3 months - Previous intraocular surgery, e.g., vitrectomy and retinal detachment treatment within the past 6 months - History of submacular surgery or other surgical intervention for diabetic macular edema Concurrent Ocular Conditions - Active intraocular inflammation - Macular edema due to ocular disorders including retinal vascular occlusion, retinal detachment, uveitis or postoperatively in the study eye - Vitreomacular traction in the study eye evident by OCT
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of short term efficacy of the Lucentis® pretreatment to laser photocoagulation compared to the combined laser photocoagulation and Lucentis® treatment in patients with clinical significant diabetic macula edema. The main focus of assessments of efficacy is: 1. The percent change in macular edema measured with standard optical coherence tomography (OCT) 2. The absolute change in visual acuity analyzed by standardized charts according to the protocol used in the Early Retreatment in Diabetic Retinopathy Study (ETDRS);Secondary Objective: To explore the effect of pretreatment with Lucentis compared to combined treatment with laser photocoagulation and Lucentis on diabetic macular edema as assessed by percent change in incidence and interval of Lucentis retreatments, percent change in macular edema measured with OCT and percent change in visual acuity (% of gained Letters) using ETDRS charts.;Primary end point(s): end of treatment | — |
Countries
Austria
Outcome results
None listed