Post Intravitreal Injection Topical NSAID vs. Patching

• ClinicalTrials.gov Identifier: NCT03918590
• Recruitment Status: Unknown
• First Posted: April 17, 2019
• Last Update Posted: April 17, 2019
• Sponsor: The New York Eye & Ear Infirmary
• Information provided by (Responsible Party): Ronald Gentile, MD, The New York Eye & Ear Infirmary

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Neovascular Age-related Macular Degeneration; Diabetic Macular Edema; Retinal Vein Occlusion	Drug: nepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX); Drug: Theratears tear drop, (Akron, Ann 111 Arbor, MI); Other: patching	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Group 1: Placebo (Preservative free artificial tears) Group 2: Nepefanac 0.3% suspension Group 3: Patch for 2 hours
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Pain Control Following Intravitreal Injection Using Topical Nepefanac 0.3% or Pressure Patching: A Prospective, Randomized, Placebo Controlled Trial
• Actual Study Start Date: December 3, 2018
• Estimated Primary Completion Date: May 1, 2019
• Estimated Study Completion Date: June 3, 2019

Arms and Interventions

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
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

Outcome Measures

Primary Outcome Measures :

1. Post Intravitreal Injection Measurement of Pain [ Time Frame: 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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, New York

New York Eye and Ear Infirmary

New York, New York, United States, 10003

Sponsors and Collaborators

The New York Eye & Ear Infirmary

More Information

• Responsible Party: Ronald Gentile, MD, Professor, The New York Eye & Ear Infirmary
• ClinicalTrials.gov Identifier: NCT03918590
• Other Study ID Numbers: 16.15
• First Posted: April 17, 2019
• Last Update Posted: April 17, 2019
• Last Verified: April 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Macular Degeneration; Macular Edema; Retinal Vein Occlusion; Retinal Degeneration; Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Nepafenac; Carboxymethylcellulose Sodium; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Laxatives; Gastrointestinal Agents