Diabetic macular edema MedDRA version: 19.0 Level: LLT Classification code 10057934 Term: Diabetic macular edema System Organ Class: 100000004853
Conditions
Interventions
Trade Name: Ozurdex
Product Name: Ozurdex
Product Code: EMEA/H/C/001140
Pharmaceutical Form: Intravitreal implant in applicator
INN or P
Sponsors
Fundación para la Investigación Biomédica del Hospital Universitario Príncipe de Asturias
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with clinically significant diabetic macular edema with new diagnosis and peripheral ischemia AVMC between 23 and 75 letters Hb1ac =65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: Previous history of glaucoma. Previous history of herpes eye infection. Prior history of vitrectomy. Previous therapeutic radiation near the eye region of the study Impossibility to perform fluorescein angiography. Inability to sign informed consent. Participation in a study with a research drug, biological product, or device within 30 days or duration of 5 half-lives of the investigational product (whichever is longer) prior to the start of the study Note: Studies that involve only over-the-counter vitamins, supplements, or diets are not included. Background of a medical disorder (disease, metabolic dysfunction, physical examination finding, clinical analytical finding) that, according to the investigator's opinion, would prevent scheduled study visits, study completion, or safe administration of the product under investigation. Any antecedent or evidence of concurrent intraocular disease in the eye of the study, such as retinal diseases other than EMD that, in the investigator's judgment, may require medical or surgical intervention during the course of the study to prevent or treat loss of acuity visual impairment that could result from that disease, or that limits the potential for visual acuity gain with treatment with the investigational product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the results of treatment of diabetic macular edema with Ozurdex® (sustained release dexamethasone implant) versus Ozurdex® plus selective photocoagulation of the areas of non-perfusion. We will compare both measured functional response and better corrected visual acuity, such as the anatomical response measured by optical coherence tomography (OCT) and the side effects of the treatment.; Secondary Objective: To evaluate the changes in central macular thickness measured by OCT. To assess changes in macular volume as measured by OCT. Number of injections required in each group. ;Primary end point(s): Corrected visual acuity measured with ETDRS after one year of treatment.;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Number of retreatments. Central foveal thickness as measured by OCT Macular volume measured by OCT ;Timepoint(s) of evaluation of this end point: 12 months | — |
Countries
Spain
Contacts
Public ContactCarolina Arruabarrena Sánchez
Hospital Universitario Príncipe de Asturias
Outcome results
None listed