BridgeMD
Tests treatment safety and results for Non-Proliferative Diabetic Retinopathy
Official title Clinical Study on the Efficacy and Safety of TNTL in the Treatment of Non-proliferative Diabetic Retinopathy
ClinicalTrials.gov ID: NCT06817265
What this study is testing
What is TNTL?
TNTL is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for non-proliferative diabetic retinopathy.
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
- The goal of this clinical trial is to learn if drug TNTL works to treat non-proliferative diabetic retinopathy in adults. It will also learn about the safety of drug TNTL.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
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 75
You may be able to join if
- Age range of 18 to 75 years old (including boundary values);
- Conform to the diagnosis of type 2 diabetes and diabetes retinopathy. diabetes retinopathy is classified as NPDR and mild and moderate patients;
- Patients with the best corrected visual acuity (BCVA) of the target eye is ≥ 34 points (ETDRS visual acuity chart, visual acuity equivalent to a...
- Patients who meet the syndrome differentiation criteria of Yin deficiency, internal heat, and eye meridian stasis in traditional Chinese medicine;
- During the screening period, glycated hemoglobin (HbA1c) should be ≤ 8.5%;
You likely can't join if
- Patients with no light perception in one eye;
- Patients with macular edema who require anti Vascular Endothelial Growth Factor(VEGF) treatment;
- People with other eye diseases, such as retinal artery or vein occlusion, non diabetes retinopathy, retinal detachment, uveitis, glaucoma, corneal...
- Patients with acute complications of diabetes (such as diabetes ketoacidosis, hyperglycemia hyperosmolality syndrome, diabetes lactic acidosis, etc.)...
- People with other eye related complications of diabetes, such as iris neovascularization, angle neovascularization, and retinal neovascularization;
- acupuncture and moxibustion and other external treatment methods of traditional Chinese medicine were used to treat diabetes retinopathy within one...
See the full eligibility criteria
- Age range of 18 to 75 years old (including boundary values);
- Conform to the diagnosis of type 2 diabetes and diabetes retinopathy. diabetes retinopathy is classified as NPDR and mild and moderate patients;
- Patients with the best corrected visual acuity (BCVA) of the target eye is ≥ 34 points (ETDRS visual acuity chart, visual acuity equivalent to a score of 20/200, decimal 0.1);
- Patients who meet the syndrome differentiation criteria of Yin deficiency, internal heat, and eye meridian stasis in traditional Chinese medicine;
- During the screening period, glycated hemoglobin (HbA1c) should be ≤ 8.5%;
- Agree to participate in this clinical study and voluntarily sign the informed consent form.
- Patients with no light perception in one eye;
- Patients with macular edema who require anti Vascular Endothelial Growth Factor(VEGF) treatment;
- People with other eye diseases, such as retinal artery or vein occlusion, non diabetes retinopathy, retinal detachment, uveitis, glaucoma, corneal ulcer, cataract affecting fundus examination, optic neuropathy and high...
- Patients with acute complications of diabetes (such as diabetes ketoacidosis, hyperglycemia hyperosmolality syndrome, diabetes lactic acidosis, etc.) within one year before the screening period;
- People with other eye related complications of diabetes, such as iris neovascularization, angle neovascularization, and retinal neovascularization;
- acupuncture and moxibustion and other external treatment methods of traditional Chinese medicine were used to treat diabetes retinopathy within one week before enrollment;
- Patients who have used drugs clearly stated in the instruction manual to treat diabetes retinopathy, such as calcium dobesilate, pancreatic kallidinogenase, Qiming Granules, Shuangdan Mingmu Capsules, Compound Danshen...
- Patients who have undergone glaucoma, vitreous, retinal and other intraocular surgeries and procedures in the target eye within 3 months before enrollment;
- Patients who have undergone cataract surgery in the target eye within 3 months prior to enrollment and have not yet stabilized according to the researcher's assessment;
- Patients who have received intravitreal injections of anti VEGF antibodies and glucocorticoids in the target eye within 3 months prior to enrollment;
- Patients who have undergone total retinal laser photocoagulation treatment in the target eye;
- For those whose refractive media is turbid and difficult to evaluate fundus images in the target eye;
- Uncontrolled or controlled blood pressure with systolic blood pressure ≥ 160mmHg and/or diastolic blood pressure ≥ 100mmHg;
- When screening, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) should be ≥ 1.5 times the upper limit of normal value;
- Patients with serious kidney disease (such as azotemia and uremia), diabetes foot, etc;
- When screening, individuals with severe primary diseases such as respiratory, cardiovascular, cerebrovascular, endocrine, digestive, and hematopoietic systems, or those with severe mental illnesses should be included;
- Suspected or confirmed history of alcohol or drug abuse;
- Pregnant women, lactating women, or women of childbearing age who are preparing to conceive; Female people of childbearing age or male people (with partners of childbearing age) who do not agree to voluntarily take...
- Individuals who are allergic to the drugs or their components used in this experiment;
- Participants who have participated in other clinical trials within the past month;
- The researchers believe that participants should not participate in the clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Xuancheng, Anhui, China
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Shenzhen, Guangdong, China
- Zhuhai, Guangdong, China
- Guiyang, Guizhou, China
- Shijiazhuang, Hebei, China
- Kaifeng, Henan, China
- Luoyang, Henan, China
- Xinxiang, Henan, China
- Zhengzhou, Henan, China
- Shiyan, Hubei, China
- Wuhan, Hubei, China
- Yichang, Hubei, China
- Hengyang, Hunan, China
- Wuxi, Jiangsu, China
- Dalian, Liaoning, China
- Jinan, Shandong, China
- Liaocheng, Shandong, China
- Xianyang, Shanxi, China
+ 4 more site(s).
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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xuancheng, Anhui, China; Beijing, Beijing Municipality, China; Guangzhou, Guangdong, China; Shenzhen, Guangdong, China; Zhuhai, Guangdong, China; Guiyang, Guizhou, China and 18 more location(s). 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.