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Post Intravitreal Injection Topical NSAID vs. Patching

Primary Purpose

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

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
nepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX)
Theratears tear drop, (Akron, Ann 111 Arbor, MI)
patching
Sponsored by
The New York Eye & Ear Infirmary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neovascular Age-related Macular Degeneration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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  • Volunteer written informed consent with the understanding that consent may be withdrawn by the subject at any time without prejudice to future care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

Sites / Locations

  • New York Eye and Ear Infirmary

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Other

Placebo Comparator

Arm Label

A single drop of nepafenac 0.3% suspension

Patching

A single drop of preservative-free Artificial Tears

Arm Description

A single drop of nepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX)

A light pressure patch applied for two hours

A single drop of preservative-free Theratears tear drop, (Akron, Ann Arbor, MI).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 4, 2019
Last Updated
April 15, 2019
Sponsor
The New York Eye & Ear Infirmary
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1. Study Identification

Unique Protocol Identification Number
NCT03918590
Brief Title
Post Intravitreal Injection Topical NSAID vs. Patching
Official Title
Pain Control Following Intravitreal Injection Using Topical Nepefanac 0.3% or Pressure Patching: A Prospective, Randomized, Placebo Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 3, 2018 (Actual)
Primary Completion Date
May 1, 2019 (Anticipated)
Study Completion Date
June 3, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The New York Eye & Ear Infirmary

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Age-related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Group 1: Placebo (Preservative free artificial tears) Group 2: Nepefanac 0.3% suspension Group 3: Patch for 2 hours
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A single drop of nepafenac 0.3% suspension
Arm Type
Active Comparator
Arm Description
A single drop of nepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX)
Arm Title
Patching
Arm Type
Other
Arm Description
A light pressure patch applied for two hours
Arm Title
A single drop of preservative-free Artificial Tears
Arm Type
Placebo Comparator
Arm Description
A single drop of preservative-free Theratears tear drop, (Akron, Ann Arbor, MI).
Intervention Type
Drug
Intervention Name(s)
nepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX)
Intervention Description
NSAID
Intervention Type
Drug
Intervention Name(s)
Theratears tear drop, (Akron, Ann 111 Arbor, MI)
Intervention Description
preservative-free Artificial Tears
Intervention Type
Other
Intervention Name(s)
patching
Intervention Description
no drug/ patching
Primary Outcome Measure Information:
Title
Post Intravitreal Injection Measurement of Pain
Description
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.
Time Frame
6 hours and 24 hours after intravitreal injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
New York Eye and Ear Infirmary
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Post Intravitreal Injection Topical NSAID vs. Patching

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