The Role of Loteprednol in Reducing Post-Intravitreal Injection Related Pain

Virginia Polytechnic Institute and State University

Status: Completed

Conditions: Age-Related Macular Degeneration

Treatments: Drug: Loteprednol Etabonate Ophthalmic Gel [Lotemax]; Other: Refresh Lubricant Eye Drops [Artificial Tears]

Study type: Interventional

Funder types: Other

Identifiers

NCT05542381

22-514

Details and patient eligibility

About

Patients are already receiving an intravitreal injection as a standard of care, but they are consenting to receiving a loteprednol drop following the intravitreal injection. This clinical trial is studying the role of loteprednol (corticosteroid) in reducing pain following intravitreal injections for patients with age-related macular degeneration. As of now, there is no definitive pain management technique following intravitreal injections. Loteprednol is a corticosteroid widely used in ophthalmology to treat pain and inflammation, however, it has not been studied as a treatment for pain following intravitreal injections. Our overall goal is to manage pain to improve quality of care after intravitreal injections. Participants will be given either loteprednol, or artificial tears following one visit for an intravitreal injection to test how effective loteprednol is in pain reduction. Pain levels will be assessed by asking participants over the phone about their pain from a scale of 0 to 10 at three different times over a 1-week period. Artificial tear and medication usage will also be tracked over a 1-week period.

Full description

Patients are already receiving an intravitreal injection as a standard of care for age-related macular degeneration, but they are consenting to receiving a loteprednol drop following the intravitreal injection for the research study. Loteprednol is used as a part of regular medical care at the Vistar Eye Center following intravitreal injections but quantifying the magnitude of pain reduction has not been done yet. Additionally, as of now there is no definitive pain management technique following intravitreal injections. This clinical trial is studying the role of loteprednol (corticosteroid) in reducing pain following intravitreal injections for patients with age-related macular degeneration. Participants will be treated with either loteprednol, or artificial tears following one visit for an intravitreal injection at the Vistar Eye Center to test how effective loteprednol is in pain reduction. Pain levels will be assessed by asking participants over the phone about their pain from a scale of 0 to 10 at 2-hours, 1-day, and 1-week following the intravitreal injection. Intravitreal injections will be performed by the retina surgeon, and phone calls will be done with the research coordinator. Artificial tear and medication usage will also be tracked over a 1-week period.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients must have age-related macular degeneration and be undergoing intravitreal injections for treatment as defined by a retina specialist.

Exclusion criteria

• Dementia
• Report baseline eye pain
• Use topical NSAIDs or steroids
• Patient under 18 years old
• History of corticosteroid responsive elevation in intraocular pressure
• Allergy to Loteprednol or Nepafenac
• Pre-existing chronic pain disorders
• Advanced Glaucoma
• Herpes zoster
• Allergy to local anesthetic or penicillin
• Patients unable to consent on own behalf
• Patients unable to communicate pain
• Pregnancy
• Incarceration

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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64 participants in 2 patient groups, including a placebo group

Loteprednol

Experimental group

Description:

1 drop of Loteprednol is administered immediately after the intravitreal injection in this treatment arm.

Treatment:

Drug: Loteprednol Etabonate Ophthalmic Gel [Lotemax]

Artificial tears

Placebo Comparator group

Description:

1 drop of artificial tears is administered immediately after the intravitreal injection in this treatment arm. This arm acts as a negative control.

Treatment:

Other: Refresh Lubricant Eye Drops [Artificial Tears]