A Phase 2 interventional study of Anti-VEGF in quadrant 1 and Anti-VEGF in quadrant 2 in Diabetic Macular Edema, sponsored by Shahid Beheshti University of Medical Sciences. Completed at 1 site in Iran. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-30.
Sponsored by Shahid Beheshti University of Medical Sciences · Phase 2, Interventional, and Prevention
In this double blind clinical trial, 1000 patients suffering from diabetic macular edema, age-related macular degeneration, neovascularization due to proliferative diabetic retinopathy and cystoid macular edema secondary to retinal vascular occlusions are included. Those with the history of Ocular pain prior to the procedure, any contraindication for Intravitreal Bevacizumab Injection (IVI), history of any kind of anterior segment conditions that could affect pain sensation, history of using systemic analgesic or sedative medications, history of previous eye surgery other than for cataract, glaucoma, uveitis and bullous keratopathy and poor cooperation in using the visual analogue scale (VAS) are excluded from the study. Before starting the treatment all patients undergo complete ophthalmic exam , best-corrected visual acuity (BCVA) checking and macular thickness measurements using optical coherence tomography (OCT). Patients are randomly assigned to each group .Each participant receive one injection in one eye in this study. Pain is measured by subjective grading on a Visual Analog Scale (VAS) immediately after IVI. BCVA and OCT would be checked again at month one.
Shahid Beheshti University of Medical Sciences is the lead sponsor of 229 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
Each participant receive one injection Anti-vascular endothelial growth factor (Anti-VEGF) in one eye in the quadrant 1
Drug: Anti-VEGF in quadrant 1
Each participant receive one injection Anti-vascular endothelial growth factor (Anti-VEGF) in one eye in the quadrant 2
Drug: Anti-VEGF in quadrant 2
Each participant receive one injection Anti-vascular endothelial growth factor (Anti-VEGF) in one eye in the quadrant 3
Drug: Anti-VEGF in quadrant 3
Each participant receive one injection Anti-vascular endothelial growth factor (Anti-VEGF) in one eye in the quadrant 4
Drug: Anti-VEGF in quadrant 4
Pain
Visual Analog Scale (VAS)
Time frame: immediately after Intravitreal Bevacizumab Injection
Best-corrected visual acuity (BCVA)
using Snellen chart
Time frame: preoperative and 1 month postoperatively.
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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Shahid Beheshti University of Medical Sciences →