Post Intravitreal Injection Topical NSAID vs. Patching

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

Detailed Description
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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.

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

Conditions
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Neovascular Age-related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion

Intervention / Treatment
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* Drug: nepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX)
* Drug: Theratears tear drop, (Akron, Ann 111 Arbor, MI)
* Other: patching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Already scheduled for anti-VEGF injection based on standard of care for disease process. Ability to provide written informed consent Capable of complying with study protocol. Volunteer written informed consent with the understanding that consent may be withdrawn by the subject at any time without prejudice to future care Exclusion Criteria: History of past intraocular injection of steroid medication. Experiencing baseline eye pain Monocular; non-study eye with VA<20/100. Unwilling or unable to follow or comply with all study related procedures

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group 1: Placebo (Preservative free artificial tears) Group 2: Nepefanac 0.3% suspension Group 3: Patch for 2 hours
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A single drop of nepafenac 0.3% suspension<br>A single drop of nepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX) | Drug: nepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX)<br>* NSAID<br>|
| Other: Patching<br>A light pressure patch applied for two hours | Other: patching<br>* no drug/ patching<br>|
| Placebo Comparator: A single drop of preservative-free Artificial Tears<br>A single drop of preservative-free Theratears tear drop, (Akron, Ann Arbor, MI). | Drug: Theratears tear drop, (Akron, Ann 111 Arbor, MI)<br>* preservative-free Artificial Tears<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Intravitreal Injection Measurement of Pain | Change from Baseline post intravitreal injection pain at 6 and 24 hours as measured by the Numeric Pain Rating Scale. The pain numeric rating scale (NRS), on which patients rate their current pain intensity from 0 (no pain) to 10 (worst possible pain), at the screening, 6 hours and 24 hours. | 6 hours and 24 hours after intravitreal injection |