Post Intravitreal Injection Topical NSAID vs. Patching

Phase 4

• Conditions: Neovascular Age-related Macular Degeneration; Diabetic Macular Edema; Retinal Vein Occlusion
• Interventions: Drug: Theratears tear drop, (Akron, Ann 111 Arbor, MI); Other: patching; Drug: nepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX)

• Registration Number: NCT03918590
• Lead Sponsor: The New York Eye & Ear Infirmary

Brief 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.

Study Timeline

• Study Start: 2018-12-03
• Status Verified: 2019-04
• Study First Submitted: 2019-04-04
• Study First Submitted QC: 2019-04-15
• Last Update Submitted: 2019-04-15
• Study First Posted: 2019-04-17
• Last Update Posted: 2019-04-17
• Primary Completion: 2019-05-01
• Study Completion: 2019-06-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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• Volunteer written informed consent with the understanding that consent may be withdrawn by the subject at any time without prejudice to future care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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A single drop of preservative-free Artificial Tears	Theratears tear drop, (Akron, Ann 111 Arbor, MI)	A single drop of preservative-free Theratears tear drop, (Akron, Ann Arbor, MI).
Patching	patching	A light pressure patch applied for two hours
A single drop of nepafenac 0.3% suspension	nepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX)	A single drop of nepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX)

Primary Outcome Measures

Name	Time	Method
Post Intravitreal Injection Measurement of Pain	6 hours and 24 hours after intravitreal injection	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.

Trial Locations

Locations (1)

New York Eye and Ear Infirmary; 🇺🇸 New York, New York, United States