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Immediate vs. Deferred Surgery for Macular Pucker (Protocol AM Trial)
Protocol AM Trial Summary
This trial is examining the best time to do surgery for people with an eye condition called an epiretinal membrane, to see if earlier surgery leads to better outcomes than waiting until vision gets worse.
Protocol AM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowProtocol AM Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Protocol AM Trial Design
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Who is running the clinical trial?
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- I have had diabetic eye disease, blocked blood vessels in my eye, or eye inflammation.I have had eye surgery before, but only for cataracts and without complications.My eye condition is not caused by another health issue.I had an inflammatory disease that was mild and resolved over a year ago.Your vision is between 20/25 and 20/40.I have had diseases affecting the blood vessels in my eyes.I have had a pneumatic retinopexy within the last year.I have a membrane affecting the central part of my retina.I have experienced new or worsening vision loss or distortion in the last 2 years.I have a membrane affecting the central part of my retina.I have had laser or cryosurgery on my retina within the last month.I have a condition where the gel in my eye is pulling on the central part of my retina.I had a retinal tear treated, with minimal fluid under the retina.My vision loss is mainly due to an epiretinal membrane.I had bleeding in my eye that led to a wrinkling on my retina.I am willing to wait 4 weeks before considering eye surgery to see if my vision stabilizes.My diabetic eye condition is moderate to severe.I am 45 years old or older.I have an untreated tear or detachment in my retina.I have had cataract surgery in the last 3 months.My vision loss is mainly due to ERM.I have no health issues that prevent me from having surgery.I have a type of macular hole in my eye.My eye condition includes a type of splitting in the retina.I have a macular hole in my eye.I have been diagnosed with central serous chorioretinopathy.I've had bleeding in my eye, but it didn't cause my retinal disease.I have no health issues that prevent me from having surgery.I have experienced new or worsening vision loss or distortion in the last 2 years, believed to be caused by ERM.I am willing to wait at least 4 weeks before considering eye surgery to see if my vision stabilizes.
- Group 1: Immediate Vitrectomy
- Group 2: Deferred Vitrectomy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
How many healthcare providers are administering this trial?
"This study has been launched in 24 locations including Spokane Eye Clinical Research, PLLC (Spokane), Valley Eye Physicians and Surgeons (Ayer), Southeast Retina Center, PC (Augusta)."
How many participants are you looking to recruit for this research endeavor?
"Affirmative, clinicaltrials.gov exhibits that this research is actively recruiting participants. The trial was initially advertised on February 22nd 2022 and has since been updated as recently as October 13th 2022. 400 individuals are being sought out from 24 different sites for the study."
Is this experiment recruiting participants presently?
"Affirmative. Clinicaltrials.gov provides evidence that this study is currently recruiting with a posting date of February 22nd 2022 and an update on October 13th 2022. A total of 400 individuals must be enlisted from 24 distinct sites."
Who else is applying?
What state do they live in?
How old are they?
What portion of applicants met pre-screening criteria?
What site did they apply to?
How many prior treatments have patients received?
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