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

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

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10003
      • New York Eye and Ear Infirmary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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• Volunteer written informed consent with the understanding that consent may be withdrawn by the subject at any time without prejudice to future care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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The New York Eye & Ear Infirmary

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2018
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): June 3, 2019

Study Registration Dates

• First Submitted: April 4, 2019
• First Submitted That Met QC Criteria: April 15, 2019
• First Posted (Actual): April 17, 2019

Study Record Updates

• Last Update Posted (Actual): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Retinal Degeneration; Retinal Diseases; Embolism and Thrombosis; Venous Thrombosis; Thrombosis; Macular Degeneration; Macular Edema; Retinal Vein Occlusion; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Gastrointestinal Agents; Laxatives; Nepafenac; Carboxymethylcellulose Sodium
• Other Study ID Numbers: 16.15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes