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Loteprednol for Post-Injection Pain in Age-Related Macular Degeneration
N/A
Recruiting
Led By Romulo Albuquerque, M.D., Ph.D.
Research Sponsored by Virginia Polytechnic Institute and State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-week post-intravitreal injection
Awards & highlights
Study Summary
This trial studies if loteprednol can reduce pain after intravitreal injections for age-related macular degeneration. Participants will get either loteprednol or artificial tears and pain levels will be monitored over 1 week.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Loteprednol may cause increased eye pressure in some people and has potential side effects typical of steroids such as blurred vision, cataracts formation or risk of infection in the eyes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-week post-intravitreal injection
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-week post-intravitreal injection
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain
Secondary outcome measures
Analgesics
Lubricant Eye Drops
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: LoteprednolExperimental Treatment1 Intervention
1 drop of Loteprednol is administered immediately after the intravitreal injection in this treatment arm.
Group II: Artificial tearsPlacebo Group1 Intervention
1 drop of artificial tears is administered immediately after the intravitreal injection in this treatment arm. This arm acts as a negative control.
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Who is running the clinical trial?
Virginia Polytechnic Institute and State UniversityLead Sponsor
143 Previous Clinical Trials
27,741 Total Patients Enrolled
Vistar Eye CenterOTHER
Romulo Albuquerque, M.D., Ph.D.Principal InvestigatorVistar Eye Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable to give my consent for medical procedures.I have age-related macular degeneration and am receiving eye injections as treatment.My condition is advanced glaucoma.I am under 18 years old.I am experiencing eye pain.I have a long-term pain condition.I use creams or ointments that are NSAIDs or steroids.My eye pressure has improved with steroid treatment.I have had shingles (herpes zoster).
Research Study Groups:
This trial has the following groups:- Group 1: Artificial tears
- Group 2: Loteprednol
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the sample size of the current clinical experiment?
"Affirmative, the clinical trial is still seeking participants. It was initially uploaded on December 22nd 2022 and modified lastly on June 12th 2023 with an aim to enrol a total of 72 patients at one location."
Answered by AI
Is entry into this research program available to participants?
"This trial, as detailed on clinicaltrials.gov, is presently in search of participants. The original posting was made on December 22nd 2022 and the most recent alteration occured June 12th 2023."
Answered by AI
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