Patients with persisting macular edema due to diabetic retinopathy. MedDRA version: 9.1 Level: LLT Classification code 10057934 Term: Diabetic macular edema
Conditions
Interventions
Trade Name: Avastin
Product Name: Bevacizumab
Product Code: L01XX28
Pharmaceutical Form: Concentrate for solution for infusion
Trade Name: Volon A
Product Name: triamcinolone
Product Code: H02AB08
P
Sponsors
Vienna Medical University, Dept. of Ophthalmology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria • Signed informed consent • Age 18 years • Patients with type 1 or type 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 20/25 to 20/400 (Snellen equivalent) in the study eye • Patients with decrease in vision in the study eye due to foveal thickening from diabetic macular edema and not to other causes, in the opinion of the investigator • Patients without a necessity for panretinal laser photocoagulation for at least 3 months after study inclusion • If both eyes are eligible, the one with the worse visual acuity will be selected for study treatment unless, based on medical reason, the investigator deems the other eye have got more benefit from study treatment. The other eye will be treated with Grid laser coagulation. 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 a patient for participation in the study in opinion of investigator, e.g., unstable medical status including glycemic control and blood pressure • History of systemic corticosteroids within 3 months prior to randomization or topical, rectal or inhaled corticosteroids in current use more than 3 times per week Prior/Concomitant Treatment • Macular laser photocoagulation • Panretinal laser photocoagulation within the past 3 months • Previous treatment with intravitreal or sub-Tenon triamcinolone within the past 3 months in the study eye • Previous participation in clinical trial involving anti-angiogenic drugs (pegabtanib sodium, ranibizumab, anecortave acetate, protein kinase C inhibitor, etc.) • History of submacular surgery or other surgical intervention for diabetic macular edema in the study eye • Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals) Diabetic Retinopathy Characteristics • High risk proliferative diabetic retinopathy in the study eye without complete panretinal lasercoagulation and having a risk for intravitreal bleeding Concurrent Ocular Conditions • Active intraocular inflammation (grade trace or above) in either eye • Vitreomacular traction in the study eye evident by OCT • Current vitreous hemorrhage in the study eye • Infectious conjunctivitis, keratitis, scleritis, endophthalmitis as well as idiopathic or autoimmuneassociated uveitis in either eye • Structural damage to the center of macula in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of retinal pigment epithelium, subretinal fibrosis, laser scar within foveal avascular zone (FAZ) or organized hard exudate plaques • Ocular disorders in the study eye including retinal vascular occlusion, retinal detachment, macular hole, choroidal neovascularisation • Intraocular surgery (including cataract surgery, YAG laser capsulotomy) in the study eye within 3 months preceding Day 0 • Uncontrolled glaucoma in the study eye (defined as intraocular pressure ?25 mmHg despite treatment with anti-glaucoma medication) • History of glaucoma filtration surgery, corneal transplantation in the study eye Concurrent Systemic Conditions • Systemic hypertension (> 150/100 mmHg) • History of myocardial infarction (in anamnesis or signs in ECG) • History of congestive heart failure • History of stroke or transient ischemic attacks • Significant abnormalities on laboratory testing (signs on failure of kidney, liver disease) • Premenopausal women not using adequate contraception and pregnant or nursing women The following are considered effective means of contraception: surgical sterilization; use of oral contraceptives; barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel; an IUD; or contraceptive hormone implant or patch. • History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications • Current treatment for active systemic infection Other • History of allergy to fluorescein, not amenable to treatment • Inability to obtain fundus photographs or fluorescein angiograms of sufficient qu
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objectives: Evaluation of efficacy of the treatment with intravitreal administered injections of Bevacizumab (Avastin®) compared with Triamcinolone (Volon A®) in patients with clinical significant diabetic macular edema. The main focus of the 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 structural mechanisms of the effect of bevacizumab (Avastin®) compared to triamcinolone (Volon A®) on diabetic macular edema as assessed by fluorescein angiography and ultra high-resolution optical coherence tomography. To observe detailed changes in retinal function, a microperimetry and a multifocal electroretinogram (mERG) will be assessed.;Primary end point(s): end of treatment | — |
Countries
Austria
Outcome results
None listed