A Phase 4 interventional study of nepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX) and Theratears tear drop, (Akron, Ann 111 Arbor, MI) in Neovascular Age-related Macular Degeneration, Diabetic Macular Edema and Retinal Vein Occlusion, sponsored by The New York Eye & Ear Infirmary. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-17.
Sponsored by The New York Eye & Ear Infirmary · Phase 4, Interventional, and Treatment
A prospective randomized trial, to evaluate post-injection comfort measures comparing topical NSAID (nepafenac 0.3% suspension) and patching.
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.
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's enrollment of 60 is above the median of 51 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →The New York Eye & Ear Infirmary is the lead sponsor of 19 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
A single drop of nepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX)
Drug: nepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX)
A light pressure patch applied for two hours
Other: patching
A single drop of preservative-free Theratears tear drop, (Akron, Ann Arbor, MI).
Drug: Theratears tear drop, (Akron, Ann 111 Arbor, MI)
NSAID
preservative-free Artificial Tears
no drug/ patching
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.
Time frame: 6 hours and 24 hours after intravitreal injection
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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The New York Eye & Ear Infirmary