Pain and Visual Outcome in Intravitreal Bevacizumab Injection (pain & visual)

Shahid Beheshti University of Medical Sciences

Status and phase: Completed; Phase 2

Conditions: Diabetic Macular Edema

Treatments: Drug: Anti-VEGF in quadrant 4; Drug: Anti-VEGF in quadrant 1; Drug: Anti-VEGF in quadrant 2; Drug: Anti-VEGF in quadrant 3

Study type: Interventional

Funder types: Other

Identifiers

NCT02790775

94312

Details and patient eligibility

About

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.

Enrollment: 1,004 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

1,004 participants in 4 patient groups

Injection Anti-VEGF in quadrant 1

Active Comparator group

Description:

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

Treatment:

Drug: Anti-VEGF in quadrant 1

Injection Anti-VEGF in quadrant 2

Active Comparator group

Description:

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

Treatment:

Drug: Anti-VEGF in quadrant 2

InjectionAnti-VEGF in quadrant 3

Active Comparator group

Description:

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

Treatment:

Drug: Anti-VEGF in quadrant 3

InjectionAnti-VEGF in quadrant 4

Active Comparator group

Description:

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

Treatment:

Drug: Anti-VEGF in quadrant 4