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Tests treatment safety and results for Diabetic Macular Edema (DME)
Official title A Phase 2 Study to Evaluate the Efficacy and Safety of ENN0403 in Subjects with DME
ClinicalTrials.gov ID: NCT06708260
What this study is testing
What is ENN0403, low dose?
ENN0403, low dose is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for diabetic macular edema (dme).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multicenter, randomized, parallel study to evaluate the efficacy and safety of two doses of ENN0403 in subjects with diabetic macular edema (DME). Approximately 60 subjects will be randomized to receive ENN0403 capsule orally once a day at the low dose or high dose with a 1:1 ratio.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Provide written informed consent;
- Aware of the entire study process and requirements, understands the importance of medication compliance and completing all assessments on time...
- Diagnosis of type 1 or type 2 diabetes mellitus and HbA1c≤10.0% with regular use hypoglycemic drugs and stable glycemic control 1 month before...
- The decrease of BCVA is mainly caused byDiabetic Macular Edema in the study eye;
- BCVA letter score of ≤ 73 (Snellen 20/40) and ≥ 24 (Snellen 20/320) at screening visit and at baseline. If both eyes meet the , the study eye will be...
You likely can't join if
- Study eye with any eye disease or medical history other than DME that causes or may cause irreversible vision loss;
- Study eye had glaucoma filtration surgery in the past or may have the surgery during the study;
- Study eye had previously undergone vitreoretinal surgery;
- Study eye received intraocular hormone drugs within 6 months prior to baseline or periocular or systemic hormone drugs within 3 months prior to...
- Any eye received intraocular injection of VEGF within 3 months prior to baseline;
- History of idiopathic or autoimmune uveitis in any eye;
See the full eligibility criteria
- Provide written informed consent;
- Aware of the entire study process and requirements, understands the importance of medication compliance and completing all assessments on time throughout the study, and agrees to strictly follow the protocol and study...
- Diagnosis of type 1 or type 2 diabetes mellitus and HbA1c≤10.0% with regular use hypoglycemic drugs and stable glycemic control 1 month before screening (at the discretion of the investigator);
- The decrease of BCVA is mainly caused byDiabetic Macular Edema in the study eye;
- BCVA letter score of ≤ 73 (Snellen 20/40) and ≥ 24 (Snellen 20/320) at screening visit and at baseline. If both eyes meet the , the study eye will be determined by the investigator from a medical perspective. ( If both...
- Optical Coherence Tomography (OCT) foveal CRT at screening measuring ≥300 μm.
- Study eye with any eye disease or medical history other than DME that causes or may cause irreversible vision loss;
- Study eye had glaucoma filtration surgery in the past or may have the surgery during the study;
- Study eye had previously undergone vitreoretinal surgery;
- Study eye received intraocular hormone drugs within 6 months prior to baseline or periocular or systemic hormone drugs within 3 months prior to baseline;
- Any eye received intraocular injection of VEGF within 3 months prior to baseline;
- History of idiopathic or autoimmune uveitis in any eye;
- Uncontrolled glaucoma in any eye (defined as IOP ≥25 mmHg after treatment with anti-glaucoma drugs)
- History of allergy to the investigational drug or any ingredient, or to any ingredient used during the treatment;
- Use of any other investigational drug or device within 3 months or 5 half-lives prior to baseline (whichever is longer);
- Other factors considered inappropriate for inclusion in this study at the discretion of the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.