Loteprednol for Post-Injection Pain in Age-Related Macular Degeneration
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using topical NSAIDs or steroids.
What data supports the effectiveness of the drug Loteprednol Etabonate Ophthalmic Gel [Lotemax] for reducing post-injection pain in age-related macular degeneration?
Loteprednol Etabonate Ophthalmic Gel has been shown to effectively reduce inflammation and pain after eye surgeries, such as cataract surgery, by improving drug delivery and penetration into eye tissues. This suggests it may also help with pain after eye injections, like those used in age-related macular degeneration.12345
Is Loteprednol safe for treating post-injection pain in age-related macular degeneration?
Loteprednol etabonate, used in eye gel form, has been shown to be safe and well-tolerated for treating inflammation and pain after eye surgery, with a low risk of increasing eye pressure. In clinical trials, side effects were rare and included mild issues like eye discomfort or swelling. This suggests it is generally safe for use in humans.12456
How does the drug loteprednol differ from other treatments for post-injection pain in age-related macular degeneration?
Loteprednol is a corticosteroid that is used in a gel form with submicron particle size, which improves its delivery and penetration into eye tissues, requiring less of the drug to be effective. This formulation is unique compared to other treatments as it is specifically designed to reduce inflammation and pain with minimal impact on eye pressure and vision.12357
What is the purpose of this trial?
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.
Research Team
Vishak John, MD
Principal Investigator
Vistar Eye Center
Romulo Albuquerque, M.D., Ph.D.
Principal Investigator
Vistar Eye Center
Eligibility Criteria
This trial is for adults with age-related macular degeneration who are getting intravitreal injections. They must not have dementia, report baseline eye pain, use certain eye medications, be under 18, have specific eye conditions like advanced glaucoma or a history of pressure increases due to steroids, allergies to study drugs, chronic pain disorders, herpes zoster; they also can't be pregnant or incarcerated.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive an intravitreal injection followed by either loteprednol or artificial tears
Follow-up
Participants are monitored for pain levels and medication usage over a 1-week period
Treatment Details
Interventions
- Loteprednol Etabonate Ophthalmic Gel [Lotemax]
- Nepafenac Ophthalmic 0.3% Ophthalmic Suspension
- Refresh Lubricant Eye Drops [Artificial Tears]
Find a Clinic Near You
Who Is Running the Clinical Trial?
Virginia Polytechnic Institute and State University
Lead Sponsor
Vistar Eye Center
Collaborator
Vistar Eye Center
Collaborator