Loteprednol for Post-Injection Pain in Age-Related Macular Degeneration

Recruiting in Palo Alto (17 mi)

Overseen by Vishak John, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Virginia Polytechnic Institute and State University

Must not be taking: Topical NSAIDs, Steroids

Disqualifiers: Dementia, Chronic pain, Glaucoma, others

Trial Summary

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.

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.

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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.

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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.

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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

I have age-related macular degeneration and am receiving eye injections as treatment.

Exclusion Criteria

I am unable to give my consent for medical procedures.

My condition is advanced glaucoma.

I am under 18 years old.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive an intravitreal injection followed by either loteprednol or artificial tears

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain levels and medication usage over a 1-week period

1 week

3 phone calls

Participant Groups

The trial tests if loteprednol (a corticosteroid) drops can reduce pain after intravitreal injections compared to artificial tears. Participants will receive one of the treatments and report their pain levels over a week via phone calls.

Group I: Loteprednol Experimental Treatment 1 Intervention

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

Group II: Artificial tears Placebo Group 1 Intervention

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Vistar Eye Center Roanoke, VA

Who Is Running the Clinical Trial?

Virginia Polytechnic Institute and State University Lead Sponsor

Vistar Eye Center Collaborator

Vistar Eye Center Collaborator

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Loteprednol Etabonate (Submicron) Ophthalmic Gel 0.38%: A Review in Post-Operative Inflammation and Pain Following Ocular Surgery. [2021] Loteprednol etabonate ophthalmic gel 0.38% (Lotemax® SM; hereafter referred to as loteprednol etabonate gel 0.38%) is a topical ophthalmic corticosteroid approved in the USA for the treatment of post-operative inflammation and pain following ocular surgery. This formulation provides improved drug delivery compared with loteprednol etabonate micronized gel 0.5%, with a smaller drug particle size (in the submicron range) to improve dissolution and penetration into ocular tissues, meaning less loteprednol etabonate is required to exert therapeutic effect. In two multicentre, randomized phase III trials, significantly more loteprednol etabonate gel 0.38% than vehicle recipients displayed complete resolution of ocular inflammation and ocular pain at day 8 post cataract surgery. Complete resolution of pain was seen as early as post-operative day 3. Treatment-related ocular adverse events in the loteprednol etabonate gel 0.38% group occurred in < 1% of subjects and included one incidence each of photophobia, cystoid macular oedema, eyelid oedema and instillation site pain. Treatment with loteprednol etabonate gel 0.38% had no meaningful impact on intraocular pressure (IOP) or visual acuity. Thus, loteprednol etabonate gel 0.38% extends the treatment options available in resolving post-operative inflammation and pain in patients who have undergone ocular surgery.

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of loteprednol etabonate 0.5% gel in the treatment of ocular inflammation and pain after cataract surgery. [2022] To examine the efficacy and safety of a new gel formulation loteprednol etabonate 0.5% in the treatment of inflammation and pain after cataract surgery.

3. United States pubmed.ncbi.nlm.nih.gov

Evaluation effectiveness of 0.1% nepafenac on injection-related pain in patients undergoing intravitreal Ozurdex injection. [2022] To evaluate the analgesic effect of topical 0.1% nepafenac solution during intravitreal Ozurdex injection.

4. New Zealand pubmed.ncbi.nlm.nih.gov

Safety and efficacy of loteprednol etabonate ophthalmic ointment 0.5% for the treatment of inflammation and pain following cataract surgery. [2022] To compare the safety and efficacy of loteprednol etabonate ophthalmic ointment 0.5% (LE ointment), a new topical ointment formulation, with vehicle for the treatment of inflammation and pain following cataract surgery.

5. New Zealand pubmed.ncbi.nlm.nih.gov

Loteprednol etabonate ophthalmic gel 0.5%: a review of its use in post-operative inflammation and pain following ocular surgery. [2021] Loteprednol etabonate ophthalmic gel 0.5% (Lotemax(®)) is approved in the USA for the treatment of post-operative inflammation and pain in patients who have undergone ocular surgery. The new gel formulation of loteprednol etabonate offers some potential advantages over the previously available ophthalmic suspension and ointment formulations of the drug. Because the gel is non-settling, a uniform dose of loteprednol etabonate is delivered without the need to vigorously shake the product. The pH of the gel formulation is close to that of physiological tears and the concentration of preservative is low. In clinical trials, loteprednol etabonate ophthalmic gel 0.5% for 14 days was effective, very well tolerated and safe when used for the treatment of post-operative inflammation and pain following cataract surgery. Relative to vehicle, loteprednol etabonate ophthalmic gel 0.5% effectively reduced postoperative ocular inflammation and ocular pain and had a similar overall tolerability, comfort and safety profile. It is associated with a low risk of inducing clinically significant increases in intraocular pressure. In conclusion, loteprednol etabonate ophthalmic gel 0.5% is an additional formulation option for the short-term treatment of post-operative inflammation and pain in patients who have undergone ocular surgery. It provides uniform dosing of a topical ophthalmic corticosteroid that has been demonstrated to be effective and well-tolerated in the treatment of ocular inflammation.

6. New Zealand pubmed.ncbi.nlm.nih.gov

Dose uniformity of loteprednol etabonate ophthalmic gel (0.5%) compared with branded and generic prednisolone acetate ophthalmic suspension (1%). [2021] Loteprednol etabonate (LE) ophthalmic gel 0.5% (Lotemax®) is a new polycarbophil-based, nonsettling topical ophthalmic formulation. The formulation is a semisolid gel at rest and a shear thinning fluid when expressed through a dropper tip. The present study was undertaken to determine how the nonsettling character of LE ophthalmic gel affects dose uniformity. Prednisolone acetate ophthalmic suspension 1% (Pred Forte®) and a generic prednisolone acetate suspension 1% were used as comparators.

7. New Zealand pubmed.ncbi.nlm.nih.gov

A retrospective analysis of the postoperative use of loteprednol etabonate gel 0.5% following laser-assisted in situ keratomileusis or photorefractive keratectomy surgery. [2022] While loteprednol etabonate ophthalmic gel 0.5% (LE gel) is approved for treatment of postoperative ocular inflammation and pain, there have been no reported studies in patients undergoing laser-assisted in situ keratomileusis (LASIK) or photorefractive keratectomy (PRK).