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Post Intravitreal Injection Topical NSAID vs. Patching

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03918590
Recruitment Status : Enrolling by invitation
First Posted : April 17, 2019
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Ronald Gentile, MD, 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.

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.

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Nepafenac

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




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.



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03918590


Locations
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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
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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    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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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