Diabetic Macular Edema MedDRA version: 9.1 Level: LLT Classification code 10057934 Term: Diabetic macular edema
Conditions
Sponsors
University of Szeged, Medical and Pharmaceutical Center, Department of Ophthalmology
Semmelweis University Department of Ophthalmology
Cholnoky F. County Hospital Veszprém Department of Ophthalmology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male of female type I. or II. diabetic patients over 18 years of age. 2. Diagnosis of DME secondary to diabetic retinopathy, and decrease in vision is due to DME and not due to other causes, in the opinion of the investigator. 3. Patients who have a BCVA score between 78 and 39 letters in the study eye using ETDRS-like visual acuity charts at a testing distance of 4 meters. 4. Expectation by the investigator that patient will potentially benefit from laser treatment or ranibizumab treatment. 5. Willing and able to comply with all study procedures. 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: 1. Active intraocular inflammation, any active infection or history of uveitis 2. Uncontrolled glaucoma or neovascularization of the iris in study eye 3. Structural damage within 0.5 disc diameter of the center of the macula in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), epiretinal membrane involving fovea or organized hard exudate plaques 4. Concurrent disease in the study eye that could compromise visual acuity or prevent the improvement of visual acuity (including diabetic proliferative retinopathy) or require medical or surgical intervention during the study period, including cataract, retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause. 5. Panretinal laser photocoagulation in the study eye within 6 months prior to or during the study or focal/grid laser photocoagulation in the study eye within 3 months prior to study entry 6. Treatment with anti-angiogenic drugs (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc.) or intravitreal corticosteroids in study eye within 3 months prior to randomization 7. Any intraocular surgery in the study eye within 3 months prior to randomization 8. History of vitrectomy in study eye 9. Ocular conditions in the study eye that require chronic concomitant therapy with topical ocular or systemically administered corticosteroids 10. Pregnancy and lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: To evaluate the mean change in best corrected visual acuity (BCVA) from Baseline over 12 months. ;Secondary Objective: Secondary objective: To evaluate the mean change in retinal thickness as assessed with OCT from Baseline over 12 months. To measure the change in the extension of foveal avascular zone, foveal thickness and macular volume by fluorescein angiography and OCT, respectively. To assess the change of foveal avascular zone extension. To assess the change in retinal function (color vision, contrast sensitivity, multifocal ERG) To evaluate the rate of adverse events ;Primary end point(s): 1. Efficacy will be assessed by mean change of BCVA measured by ETDRS charts and mean change of retinal thickness measured by optical coherence tomography over 12 month. | — |
Countries
Hungary
Outcome results
None listed