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Levodopa for Diabetic Retinopathy (TESDR Trial)
TESDR Trial Summary
This trial will test whether levodopa can slow the progression of diabetes-related changes in the retina.
TESDR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTESDR Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.TESDR Trial Design
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Who is running the clinical trial?
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- Your eyes do not respond normally to low-intensity flashing lights.I haven't taken anti-VEGF or steroids in the past year.You have trouble with memory and thinking, as measured by a test called the Montreal Cognitive Assessment (MOCA), scoring 24 or less.I am diabetic and have tiny blood vessel changes in my eyes.Your HbA1c levels are between 8% and 12%.I am diabetic and my eye screening showed no signs of retinopathy.I have a pituitary tumor, psychosis, or Parkinson's disease.I do not have major eye diseases like cataract, glaucoma, or macular degeneration.
- Group 1: follow-up
- Group 2: Sinemet
- Group 3: Placebo
- 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
What primary indications are there for Sinemet CR?
"Sinemet CR is chiefly used for manganese intoxication, though it also shows promise in alleviating advanced motor fluctuations, RLS (Restless Legs Syndrome) and carbon monoxide poisoning."
Is eligibility available to me as a prospective participant in this research?
"This medical trial seeks 244 individuals aged between 30 and 80 who have diabetic retinopathy, as well as delayed ERG oscillatory potentials in response to dim flash stimuli."
How many participants are included in the sample size of this trial?
"This clinical trial is no longer accepting participants. It was posted on July 1st of 2022 and last updated on the 14th of July, making it currently inactive for enrollment. However, if you are looking to join another study concerning diabetic retinopathy, there are presently 111 ongoing trials recruiting patients or 16 studies utilizing Sinemet CR that need volunteers."
Are there any vacancies available for those wishing to join this research project?
"As indicated by the clinicaltrials.gov portal, recruitment for this trial has been concluded. Initially posted on July 1st 2022 and last modified on July 14th 2022, it is now superseded by 127 other medical trials that are accepting enrollees at present."
What additional investigations have been performed with regard to Sinemet CR?
"Currently, there are 16 ongoing trials researching Sinemet CR with 4 in their final stage of development. Madison, Wisconsin is the hub of these studies; however, 253 additional sites across the world are also participating."
Does this research study include elderly individuals in its participant population?
"The age restrictions for this clinical trial mandates that potential participants must be between 30 and 80 years old. Additionally, there are special trials available to those under 18 as well as over 65."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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