Comparison of the efficacy of treatment of retinal macular inflammation due to diabetes with ozurdex or with ozurdex plus laser treatment in the area.
- Conditions
- Diabetic macular edemaMedDRA version: 19.0 Level: LLT Classification code 10057934 Term: Diabetic macular edema System Organ Class: 100000004853Therapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2016-003870-41-ES
- Lead Sponsor
- Fundación para la Investigación Biomédica del Hospital Universitario Príncipe de Asturias
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 30
Patients with clinically significant diabetic macular edema with new diagnosis and peripheral ischemia
AVMC between 23 and 75 letters
Hb1ac <9
Pseudophakic
Over 18 years
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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.;<br> Secondary Objective: To evaluate the changes in central macular thickness measured by OCT.<br> To assess changes in macular volume as measured by OCT.<br> Number of injections required in each group.<br> ;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 Outcome Measures
Name Time Method <br> Secondary end point(s): Number of retreatments.<br> Central foveal thickness as measured by OCT<br> Macular volume measured by OCT<br> ;Timepoint(s) of evaluation of this end point: 12 months