Post Intravitreal Injection Topical NSAID vs. Patching
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|ClinicalTrials.gov Identifier: NCT03918590|
Recruitment Status : Enrolling by invitation
First Posted : April 17, 2019
Last Update Posted : April 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Neovascular Age-related Macular Degeneration Diabetic Macular Edema Retinal Vein Occlusion||Drug: nepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX) Drug: Theratears tear drop, (Akron, Ann 111 Arbor, MI) Other: patching||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Group 1: Placebo (Preservative free artificial tears) Group 2: Nepefanac 0.3% suspension Group 3: Patch for 2 hours|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Pain Control Following Intravitreal Injection Using Topical Nepefanac 0.3% or Pressure Patching: A Prospective, Randomized, Placebo Controlled Trial|
|Actual Study Start Date :||December 3, 2018|
|Estimated Primary Completion Date :||May 1, 2019|
|Estimated Study Completion Date :||June 3, 2019|
Active Comparator: A single drop of nepafenac 0.3% suspension
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
no drug/ patching
Placebo Comparator: A single drop of preservative-free Artificial Tears
A single drop of preservative-free Theratears tear drop, (Akron, Ann Arbor, MI).
Drug: Theratears tear drop, (Akron, Ann 111 Arbor, MI)
preservative-free Artificial Tears
- Post Intravitreal Injection Measurement of Pain [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03918590
|United States, New York|
|New York Eye and Ear Infirmary|
|New York, New York, United States, 10003|