Pain and Visual Outcome in Intravitreal Bevacizumab Injection

Phase 2

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Drug: Anti-VEGF in quadrant 2; Drug: Anti-VEGF in quadrant 1; Drug: Anti-VEGF in quadrant 3; Drug: Anti-VEGF in quadrant 4

• Registration Number: NCT02790775
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-09
• Study Start: 2015-12
• Primary Completion: 2016-05-30
• Study First Submitted: 2016-06-01
• Study First Submitted QC: 2016-06-01
• Study First Posted: 2016-06-06
• Study Completion: 2016-08-30
• Last Update Submitted: 2017-08-29
• Last Update Posted: 2017-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1004

Inclusion Criteria

• diabetic macular edema, age-related macular degeneration, neovascularization due to proliferative diabetic retinopathy and cystoid macular edema secondary to retinal vascular occlusions

Exclusion Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Injection Anti-VEGF in quadrant 2	Anti-VEGF in quadrant 2	Each participant receive one injection Anti-vascular endothelial growth factor (Anti-VEGF) in one eye in the quadrant 2
Injection Anti-VEGF in quadrant 1	Anti-VEGF in quadrant 1	Each participant receive one injection Anti-vascular endothelial growth factor (Anti-VEGF) in one eye in the quadrant 1
InjectionAnti-VEGF in quadrant 3	Anti-VEGF in quadrant 3	Each participant receive one injection Anti-vascular endothelial growth factor (Anti-VEGF) in one eye in the quadrant 3
InjectionAnti-VEGF in quadrant 4	Anti-VEGF in quadrant 4	Each participant receive one injection Anti-vascular endothelial growth factor (Anti-VEGF) in one eye in the quadrant 4

Primary Outcome Measures

Name	Time	Method
Pain	immediately after Intravitreal Bevacizumab Injection	Visual Analog Scale (VAS)

Secondary Outcome Measures

Name	Time	Method
Best-corrected visual acuity (BCVA)	preoperative and 1 month postoperatively.	using Snellen chart

Trial Locations

Locations (1)

Islamic Republic of Iran; 🇮🇷 Tehran, Iran, Islamic Republic of