Diabetic Macular Edema, Neovascular Age-related Macular Degeneration, Retinal Vein Occlusion
Conditions
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.
Interventions
DRUGnepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX)
NSAID
DRUGTheratears tear drop, (Akron, Ann 111 Arbor, MI)
preservative-free Artificial Tears
OTHERpatching
no drug/ patching
Sponsors
The New York Eye & Ear Infirmary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Group 1: Placebo (Preservative free artificial tears) Group 2: Nepefanac 0.3% suspension Group 3: Patch for 2 hours
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 * Volunteer written informed consent with the understanding that consent may be withdrawn by the subject at any time without prejudice to future care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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post Intravitreal Injection Measurement of Pain | 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. |
Countries
United States
Outcome results
None listed