Pain and Visual Outcome in Intravitreal Bevacizumab Injection

Diabetic Macular Edema Clinical Trial

— pain & visual  

Official title:

Evaluation of the Pain and Visual Outcome Associated With Location of Intravitreal Bevacizumab Injection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02790775
• Other study ID #: 94312
• Status: Completed
• Phase: Phase 2
• First received: June 1, 2016
• Last updated: August 29, 2017
• Start date: December 2015
• Est. completion date: August 30, 2016

Study information

• Verified date: September 2015
• Source: Shahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1004
• Est. completion date: August 30, 2016
• Est. primary completion date: May 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Macular Edema

Intervention

Drug:
• Anti-VEGF in quadrant 1

• Anti-VEGF in quadrant 2

• Anti-VEGF in quadrant 3

• Anti-VEGF in quadrant 4

Locations

Country	Name	City	State
Iran, Islamic Republic of	Islamic Republic of Iran	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Visual Analog Scale (VAS)	immediately after Intravitreal Bevacizumab Injection
Secondary	Best-corrected visual acuity (BCVA)	using Snellen chart	preoperative and 1 month postoperatively.