NCT03918590

Post Intravitreal Injection Topical NSAID vs. Patching

Pain Control Following Intravitreal Injection Using Topical Nepefanac 0.3% or Pressure Patching: A Prospective, Randomized, Placebo Controlled Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: The New York Eye & Ear Infirmary · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective randomized trial, to evaluate post-injection comfort measures comparing topical NSAID (nepafenac 0.3% suspension) and patching.

Detailed description

This is a single masked, randomized, placebo-controlled study that will enroll approximately 60 subjects with recent active retina related disease requiring intravitreal agents. Subjects will be randomized into one of 3 groups in a 1:1:1 ratio, and assigned to receive nepafenac 0.3% suspension or a sham procedure. Subjects will have a one in three (33%) chance of receiving active treatment (no sham procedure), a one in three (33%) chance of receiving patching procedure (no active treatment) or a one in three (33%) chance of receiving placebo (no active treatment). Study participants will then complete the Visual Analog Scale immediately following injection and then after 1 hour, and, 24 hours. The VAS data along with relevant data related to each subject's injection will also be compiled, including, but not limited to: drug injected, diagnosis, co-morbid conditions, history of previous injections, visual acuity, age, and gender.

Conditions

• Neovascular Age-related Macular Degeneration
• Diabetic Macular Edema
• Retinal Vein Occlusion

Interventions

Type	Name	Description
DRUG	nepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX)	NSAID
DRUG	Theratears tear drop, (Akron, Ann 111 Arbor, MI)	preservative-free Artificial Tears
OTHER	patching	no drug/ patching

Timeline

• Start date: 2018-12-03
• Primary completion: 2019-05-01
• Completion: 2019-06-03
• First posted: 2019-04-17
• Last updated: 2019-04-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study