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CU06-1004 for Diabetic Macular Edema
Phase 2
Waitlist Available
Research Sponsored by Curacle Co., Ltd.
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 baseline, 4 weeks, 8 weeks and 12 weeks
Awards & highlights
Study Summary
This trial studies the safety and effectiveness of a new drug for treating a form of eye disease (DME) in 60 patients over 12 weeks.
Who is the study for?
This trial is for adults over 18 with Type 1 or Type 2 diabetes who have swelling in the retina due to diabetic macular edema. Participants must have certain levels of retinal thickness and vision range, and be able to undergo eye photography. Exclusions include recent cardiovascular events, certain past treatments like intravitreal injections, uncontrolled health conditions, pregnancy, or not using contraception.Check my eligibility
What is being tested?
The study tests CU06-1004's effectiveness and safety in treating diabetic macular edema when taken orally once a day for 12 weeks. There are three different dosage groups (100mg, 200mg, and 300mg), with patients randomly assigned to one of these groups in equal numbers.See study design
What are the potential side effects?
While specific side effects for CU06-1004 aren't listed here, common side effects from similar oral medications may include gastrointestinal issues like nausea or diarrhea, potential liver function changes detectable by blood tests, fatigue or dizziness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 4 weeks, 8 weeks and 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4 weeks, 8 weeks and 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To determine the optimal doses
Secondary outcome measures
Change in diabetic retinopathy severity scale (DRSS)
Number and severity of treatment emergent adverse events (TEAEs)
The change of all other subfield thickness
+3 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: CU06-1004 300mgExperimental Treatment1 Intervention
CU06-1004 100 mg tablets. Dosed at 300 mg (3 capsules) QD within 30 minutes after meal on each evening
Group II: CU06-1004 200mgExperimental Treatment1 Intervention
CU06-1004 100 mg tablets. Dosed at 200 mg (2 capsules) QD within 30 minutes after meal on each evening
Group III: CU06-1004 100mgExperimental Treatment1 Intervention
CU06-1004 100 mg tablets. Dosed at 100 mg (1 capsule) QD within 30 minutes after meal on each evening
Find a Location
Who is running the clinical trial?
Laboratorios Thea, FranceUNKNOWN
Laboratoires Thea, FranceUNKNOWN
Théa Open Innovation, FranceUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My macular edema is not caused by diabetes.I have received gene therapy for a condition.I have had a retinal detachment or surgery to fix a detached retina.My blood pressure is not higher than 180/100 mmHg.My diabetes is not under control (HbA1c > 12.0%).I have tested positive for HIV or Hepatitis B/C.I have had eye surgery in the last 3 months or plan to in the next 6 months.I had a YAG laser eye procedure within the last 2 months.I have been vaccinated for COVID-19 within the last 30 days or will remain vaccinated throughout the study.I have been diagnosed with Type 1 or Type 2 diabetes.My eye condition is due to diabetes affecting the center of my vision.I have had laser treatment for my entire retina.I have an eye infection or inflammation, like pink eye or eyelid issues.I am 18 years old or older.I have an active eye inflammation.My eye's central thickness meets the required measurements for the study.I haven't been in a drug trial for a biological agent in the last 3 months or any trial in the last month.I haven't had major heart or stroke issues in the last 6 months.I am not pregnant or breastfeeding and agree to use birth control for 6 months.I have been treated with intravitreal fluocinolone astonide before.I have glaucoma that is not under control.I might need laser eye treatment in the next 3 months.I have had eye inflammation that's not from normal surgery recovery.I haven't had major surgery in the last 3 months and don't plan any in the next 6 months.I have had surgery to remove the vitreous gel from my eye.I have taken vaccinium myrtillus extract or dobesilate calcium in the last 2 weeks.I haven't had anti-VEGF, laser eye treatment in the last 3 months, or eye injections in the last 6 months.I have an eye condition that could affect my vision during the study, aside from diabetes.You have a high score on the DRSS scale, which measures the severity of diabetic retinopathy.
Research Study Groups:
This trial has the following groups:- Group 1: CU06-1004 300mg
- Group 2: CU06-1004 100mg
- Group 3: CU06-1004 200mg
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Diabetic Macular Edema Patient Testimony for trial: Trial Name: NCT05573100 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there any risk associated with the administration of CU06-1004 100mg?
"There is some evidence of safety for CU06-1004 100mg, which earned it a score of 2. However, as this trial is currently in Phase 2 there has yet to be any proof that the drug holds therapeutic efficacy."
Answered by AI
How many health centers are presently conducting this research study in the city?
"Patients are being recruited across 7 medical centres, including Mid Atlantic Retina in Philadelphia, Elman Retina Group in Baltimore, and Retina Consultants of Texas in Bellaire."
Answered by AI
Would this investigation be open to new participants?
"Per the information presented on clinicaltrials.gov, this trial has stopped recruiting patients since October 6th 2022. Despite that, there are still 114 other trials accepting participants at present time."
Answered by AI
Who else is applying?
What state do they live in?
Illinois
Florida
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
1
2
What site did they apply to?
Rand Eye Institute
Why did patients apply to this trial?
I have tried a few different things to make my condition better but with no success . I am a very active athlete and enjoy my sports intensely however my eye condition limits me tremendously and am getting fearful and worried of my future. Been a diabetic for.
PatientReceived no prior treatments
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