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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
Awards & highlights
AN Trial 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.Check my eligibility
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.See study design
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.
AN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean change in central subfield thickness
Secondary outcome measures
Mean change in retinal volume from baseline
Mean change in visual acuity from baseline
Percentage of eyes central subfield thickness below optical coherence machine- and sex-specific threshold for DME and at least a 10% decrease from baseline
+1 moreAN 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
232 Previous Clinical Trials
141,656 Total Patients Enrolled
Jaeb Center for Health ResearchLead Sponsor
153 Previous Clinical Trials
34,783 Total Patients Enrolled
National Eye Institute (NEI)NIH
547 Previous Clinical Trials
1,402,029 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many sites in the United States are currently executing this clinical trial?
"This research study is currently recruiting patients at 7 distinct medical centres. These locations exist in Lakeland, Augusta, Baltimore and other nearby areas. To minimize the burden of travel for participants, they should select a site that is nearest to their residence."
Answered by AI
Are there opportunities to join this clinical trial still available?
"Affirmative - the research hosted on clinicaltrials.gov attests to this medical trial's ongoing recruitment process, which was established May 2nd 2023 and last revised June 15th of that same year. 128 volunteers need to be recruited from 7 distinct sites."
Answered by AI
Has Tonabersat (80 mg) been granted permission from the FDA to be used?
"Our team at Power assessed the safety of Tonabersat (80 mg) as a 2. This rating is due to its Phase 2 trial status, with evidence confirming that it's safe yet no information proving efficacy."
Answered by AI
How many participants have been included in this research initiative?
"This clinical study requires 128 people that fit the specified criteria to join. Participants can find locations such as Central Florida Retina Institute in Lakeland, Georgia and Florida Retina Consultants in Augusta, Maryland where they may take part."
Answered by AI
Who else is applying?
What site did they apply to?
Retina Associates of Southern California
What portion of applicants met pre-screening criteria?
Did not meet criteria
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