Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT01218750
Brief Summary:
The purpose of this study is to evaluate the safety end efficacy of combined phakoemulsification and vitrectomy with retinal endophotocoagulation and intraoperative use of bevacizumab in patients with diffuse diabetic macular edema (DDME), to determine the possible preoperative and intraoperative factors that might influence surgical outcomes.
Detailed Description:
The pathogenesis of the diabetic macular edema is multiple. Therefore treatment of this disease should be combined too. VEGF is involved in pathogenesis of diabetic macular edema and recently anti-VEGF agents such as bevacizumab have been shown to be beneficial in the treatment of this retinal disorder. However, endogenous VEGF is required for visual function. Growing body evidence indicates that VEGF acts also on nonvascular cells, it plays survival role on Muller cells and photoreceptors. Therefore anti-VEGF therapies should be administered with caution and not persistent. Photocoagulation in nonperfused areas eliminate increased production of VEGF, proliferation of RPE and increased production of PEDF in surrounded impact laser area. Vitrectomy with ILM peeling reliefs traction on the macula, improve oxygenation of the macula leading to decreased vascular permeability with subsequent resolution or decrease in DME. Removed ILM contains a part of the Müller cell endfeet and the horizontal gliosis. It is likely that the proliferation of GFAP-stained gliofibrils, observed in microdamaged Müller cells, preserves the blood-retinal barrier, reinforces architectural cohesion, and opposes the installation of the edema. Therefore, we made hypothesis that combined triple therapy was effective for decreasing macular thickness and improvement of vision for eyes with diffuse diabetic macular edema.
It is important for the surgeon to determine the factors that might influence surgical outcome so that patients are chosen for the procedure that they can get benefit from. Therefore, we evaluated the possible preoperative and intraoperative factors that might influence surgical outcomes
Study:
NCT01218750
Study Brief:
Protocol Section:
NCT01218750