Post Intravitreal Injection Topical NSAID vs. Patching

NCT ID: NCT03918590

Last Updated: 2019-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-03

Study Completion Date

2019-06-03

Brief Summary

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

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Group 1: Placebo (Preservative free artificial tears) Group 2: Nepefanac 0.3% suspension Group 3: Patch for 2 hours
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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A single drop of nepafenac 0.3% suspension

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

Group Type ACTIVE_COMPARATOR

nepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX)

Intervention Type DRUG

NSAID

Patching

A light pressure patch applied for two hours

Group Type OTHER

patching

Intervention Type OTHER

no drug/ patching

A single drop of preservative-free Artificial Tears

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

Group Type PLACEBO_COMPARATOR

Theratears tear drop, (Akron, Ann 111 Arbor, MI)

Intervention Type DRUG

preservative-free Artificial Tears

Interventions

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nepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX)

NSAID

Intervention Type DRUG

Theratears tear drop, (Akron, Ann 111 Arbor, MI)

preservative-free Artificial Tears

Intervention Type DRUG

patching

no drug/ patching

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The New York Eye & Ear Infirmary

OTHER

Sponsor Role lead

Responsible Party

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Ronald Gentile, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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New York Eye and Ear Infirmary

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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16.15

Identifier Type: -

Identifier Source: org_study_id

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