Post Intravitreal Injection Topical NSAID vs. Patching

Diabetic Macular Edema Clinical Trial

Official title:

Pain Control Following Intravitreal Injection Using Topical Nepefanac 0.3% or Pressure Patching: A Prospective, Randomized, Placebo Controlled Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03918590
• Other study ID #: 16.15
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: December 3, 2018
• Est. completion date: June 3, 2019

Study information

• Verified date: April 2019
• Source: The New York Eye & Ear Infirmary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: June 3, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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• Volunteer written informed consent with the understanding that consent may be withdrawn by the subject at any time without prejudice to future care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

Related Conditions & MeSH terms

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

Intervention

Drug:
• nepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX)
NSAID
• Theratears tear drop, (Akron, Ann 111 Arbor, MI)
preservative-free Artificial Tears

Other:
• patching
no drug/ patching

Locations

Country	Name	City	State
United States	New York Eye and Ear Infirmary	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
The New York Eye & Ear Infirmary

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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