Short term effect of Lucentis® (Ranibizumab) as pretreatment to laser photocoagulation versus Lucentis® (Ranibizumab) combined with laser photocoagulation in the treatment of diabetic macular edema. A prospective, randomized study. - Lucentis und Laser
- Conditions
- Patients with macular edema due to diabetic retinopathyMedDRA version: 12.1Level: LLTClassification code 10060837Term: Choroidal neovascularization
- Registration Number
- EUCTR2010-022473-33-AT
- Lead Sponsor
- Department of Ophthalmology, Hietzing Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): end of treatment;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:<br>1. The percent change in macular edema measured with standard optical coherence tomography (OCT)<br>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.
- Secondary Outcome Measures
Name Time Method