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Tonabersat for Diabetic Macular Edema (AN Trial)
Phase 2
Recruiting
Research Sponsored by Jaeb Center for Health Research
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 6 months
Summary
This trial will study if a drug can help improve sight in people with diabetes-related vision loss.
Who is the study for?
This trial is for adults with type 1 or 2 diabetes who have diabetic macular edema (DME) affecting the center of their retina but still have good vision (20/25 or better). Participants must meet specific criteria based on retinal thickness measurements. They shouldn't have had certain eye treatments in the past year, need upcoming major eye surgery, or suffer from severe kidney or liver conditions.
What is being tested?
The study tests Tonabersat against a placebo to see if it can reduce the thickness in the central part of the retina in patients with DME and good visual acuity. Patients are randomly assigned to receive either Tonabersat or a placebo, without choosing which one they get.
What are the potential side effects?
While specific side effects for Tonabersat in this context aren't provided here, common side effects may include headache, dizziness, nausea, and potential allergic reactions. Placebo typically has no active ingredients but can cause perceived side effects due to patient expectations.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Percentage of eyes central subfield thickness below optical coherence machine- and sex-specific threshold for DME and at least a 10% decrease from baseline
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Tonabersat (80 mg)Active Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
Juvenile Diabetes Research FoundationOTHER
234 Previous Clinical Trials
141,953 Total Patients Enrolled
Jaeb Center for Health ResearchLead Sponsor
158 Previous Clinical Trials
35,821 Total Patients Enrolled
National Eye Institute (NEI)NIH
555 Previous Clinical Trials
1,407,264 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had surgery to remove the vitreous gel from my eye.My eye scan shows swelling in the center of my retina due to diabetes.One of my eyes meets the trial's requirements.I've had treatments for diabetic eye issues but no more than 4 anti-VEGF injections.I haven't taken any VEGF-targeting drugs in the last year.I have chronic kidney failure and need dialysis or have had a kidney transplant.My liver function tests are more than three times the normal limit.I have not had major eye surgery in the last 4 months and do not plan to.I have type 1 or type 2 diabetes.My macular edema is not caused by diabetic macular edema.I might need treatment for eye conditions or cataract surgery soon.My eye measurement is above the threshold for my gender.My eye condition involves swelling in the center part, confirmed by an eye scan.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Tonabersat (80 mg)
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.
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