Post Intravitreal Injection Topical NSAID vs. Patching

The New York Eye & Ear Infirmary

Status and phase: Unknown; Phase 4

Conditions: Diabetic Macular Edema; Neovascular Age-related Macular Degeneration; Retinal Vein Occlusion

Treatments: Drug: Theratears tear drop, (Akron, Ann 111 Arbor, MI); Drug: nepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX); Other: patching

Study type: Interventional

Funder types: Other

Identifiers

NCT03918590

16.15

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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• Volunteer written informed consent with the understanding that consent may be withdrawn by the subject at any time without prejudice to future care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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups, including a placebo group

A single drop of nepafenac 0.3% suspension

Active Comparator group

Description:

A single drop of nepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX)

Treatment:

Drug: nepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX)

Patching

Other group

Description:

A light pressure patch applied for two hours

Treatment:

Other: patching

A single drop of preservative-free Artificial Tears

Placebo Comparator group

Description:

A single drop of preservative-free Theratears tear drop, (Akron, Ann Arbor, MI).

Treatment:

Drug: Theratears tear drop, (Akron, Ann 111 Arbor, MI)