Post Intravitreal Injection Topical NSAID vs. Patching

NCT03918590 | Unknown Phase 4 FDA Drug

• 1 other identifier: 16.15
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

A single drop of nepafenac 0.3% suspension

ACTIVE COMPARATOR

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

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

Patching

OTHER

A light pressure patch applied for two hours

Other: patching

A single drop of preservative-free Artificial Tears

PLACEBO COMPARATOR

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

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

Interventions

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

NSAID

A single drop of nepafenac 0.3% suspension

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

preservative-free Artificial Tears

A single drop of preservative-free Artificial Tears

patching OTHER

no drug/ patching

Patching

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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• Volunteer written informed consent with the understanding that consent may be withdrawn by the subject at any time without prejudice to future care

You may not qualify if:

• 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

Sponsors & Collaborators

• The New York Eye & Ear Infirmary: lead

Study Sites (1)

New York Eye and Ear Infirmary

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Retinal Vein Occlusion

Interventions

nepafenac; Suspensions; methylacetylene

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Group 1: Placebo (Preservative free artificial tears) Group 2: Nepefanac 0.3% suspension Group 3: Patch for 2 hours

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: April 17, 2019
• Study Start: December 3, 2018
• Primary Completion: May 1, 2019
• Study Completion: June 3, 2019
• Last Updated: April 17, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)