Pain and Visual Outcome in Intravitreal Bevacizumab Injection

NCT02790775 | Completed Phase 2 DMC

• 1 other identifier: 94312
• Study Type: interventional
• Target: 1,004
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Pain

  Visual Analog Scale (VAS)

  immediately after Intravitreal Bevacizumab Injection

Secondary Outcomes (1)

• Best-corrected visual acuity (BCVA)

  preoperative and 1 month postoperatively.

Study Arms (4)

Injection Anti-VEGF in quadrant 1

ACTIVE COMPARATOR

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

Injection Anti-VEGF in quadrant 2

ACTIVE COMPARATOR

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

InjectionAnti-VEGF in quadrant 3

ACTIVE COMPARATOR

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

InjectionAnti-VEGF in quadrant 4

ACTIVE COMPARATOR

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

Interventions

Anti-VEGF in quadrant 1 DRUG

Injection Anti-VEGF in quadrant 1

Anti-VEGF in quadrant 2 DRUG

Injection Anti-VEGF in quadrant 2

Anti-VEGF in quadrant 3 DRUG

InjectionAnti-VEGF in quadrant 3

Anti-VEGF in quadrant 4 DRUG

InjectionAnti-VEGF in quadrant 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Islamic Republic of Iran

Tehran, Iran

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthalmic Research center

Study Record Dates

• First Submitted: June 1, 2016
• First Posted: June 6, 2016
• Study Start: December 1, 2015
• Primary Completion: May 30, 2016
• Study Completion: August 30, 2016
• Last Updated: August 30, 2017

Record last verified: 2015-09

Locations

IR (1)