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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A single drop of nepafenac 0.3% suspension | Active Comparator | A single drop of nepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX) |
|
| Patching | Other | A light pressure patch applied for two hours |
|
| A single drop of preservative-free Artificial Tears | Placebo Comparator | A single drop of preservative-free Theratears tear drop, (Akron, Ann Arbor, MI). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX) | Drug | NSAID |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Eye and Ear Infirmary | New York | New York | 10003 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 19, 2019 | |
| Reset | Jun 11, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 19, 2019 | Jun 11, 2019 |
| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
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| ID | Term |
|---|---|
| C414203 | nepafenac |
| D013535 | Suspensions |
| C022030 | methylacetylene |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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Group 1: Placebo (Preservative free artificial tears) Group 2: Nepefanac 0.3% suspension Group 3: Patch for 2 hours
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| Theratears tear drop, (Akron, Ann 111 Arbor, MI) | Drug | preservative-free Artificial Tears |
|
| patching | Other | no drug/ patching |
|
| D016769 |
| Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |