Pain and Visual Outcome in Intravitreal Bevacizumab Injection

NCT ID: NCT02790775

Last Updated: 2017-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 1004 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-08-30

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.

Conditions

Diabetic Macular Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Injection Anti-VEGF in quadrant 1

Each participant receive one injection Anti-vascular endothelial growth factor (Anti-VEGF) in one eye in the quadrant 1

Group Type: ACTIVE_COMPARATOR

Anti-VEGF in quadrant 1

Intervention Type: DRUG

Injection Anti-VEGF in quadrant 2

Each participant receive one injection Anti-vascular endothelial growth factor (Anti-VEGF) in one eye in the quadrant 2

Group Type: ACTIVE_COMPARATOR

Anti-VEGF in quadrant 2

Intervention Type: DRUG

InjectionAnti-VEGF in quadrant 3

Each participant receive one injection Anti-vascular endothelial growth factor (Anti-VEGF) in one eye in the quadrant 3

Group Type: ACTIVE_COMPARATOR

Anti-VEGF in quadrant 3

Intervention Type: DRUG

InjectionAnti-VEGF in quadrant 4

Each participant receive one injection Anti-vascular endothelial growth factor (Anti-VEGF) in one eye in the quadrant 4

Group Type: ACTIVE_COMPARATOR

Anti-VEGF in quadrant 4

Intervention Type: DRUG

Interventions

Anti-VEGF in quadrant 1

Intervention Type: DRUG

Anti-VEGF in quadrant 2

Intervention Type: DRUG

Anti-VEGF in quadrant 3

Intervention Type: DRUG

Anti-VEGF in quadrant 4

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Zahra Rabbani Khah

Ophthalmic Research center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Islamic Republic of Iran

Tehran, , Iran

Countries

Iran

Other Identifiers

94312

Identifier Type: -

Identifier Source: org_study_id