Post Intravitreal Injection Topical NSAID vs. Patching

Diabetic Macular Edema Clinical Trial

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

Status Enrolling by invitation

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT03918590
• Study type: Interventional
• Source: The New York Eye & Ear Infirmary
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: December 3, 2018
• Completion date: June 3, 2019