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Tests treatment safety and results for Diabetic Macular Edema (DME)
Official title Efficacy Evaluation Study of BAT5906 and Lucentis® in Patients With Diabetic Macular Edema
ClinicalTrials.gov ID: NCT07515079
What this study is testing
What is BAT5906 injection?
BAT5906 injection is an investigational medicine, given as an injectable medicine, 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
- A multicenter, randomized, double-blind, parallel-group, active-controlled non-inferiority trial. A total of 406 subjects with diabetic macular edema (DME) were planned for enrollment.
- Phase 3: a large, late-stage study
- 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
- All of the following criteria must be met for inclusion:
- Voluntarily signed informed consent form, willing and able to comply with outpatient visits and study procedures as scheduled by the trial.
- Diagnosed with type 1 or type 2 diabetes, aged 18 to 80 years (including boundary values).
- Diabetic macular edema (DME) with OCT findings demonstrating involvement of the macular center (fovea or paracentral fovea) in the study eye. (fovea...
- Central retinal thickness (CRT) of the study eye \>300 μm (or \>320 μm for Heidelberg OCT) as assessed by central image review during screening;
You likely can't join if
- Patients meeting any of the following criteria will be excluded from this study:
- Presence of structural damage in the central macula of the study eye that may prevent improvement in best-corrected visual acuity after resolution of...
- Presence of any condition in the study eye other than diabetic macular edema that may confound fundus evaluation or visual acuity testing (e.g...
- Aphakia in the study eye or presence of an intraocular lens with posterior capsule opacification (exemption granted for posterior capsule...
- The study eye has uncontrolled glaucoma (intraocular pressure \>25 mmHg despite antiglaucoma medication); or a history of glaucoma filtration...
- The study eye has undergone vitreoretinal surgery or scleral buckling;
See the full eligibility criteria
Who can join
- All of the following criteria must be met for inclusion:
- Voluntarily signed informed consent form, willing and able to comply with outpatient visits and study procedures as scheduled by the trial.
- Diagnosed with type 1 or type 2 diabetes, aged 18 to 80 years (including boundary values).
- Diabetic macular edema (DME) with OCT findings demonstrating involvement of the macular center (fovea or paracentral fovea) in the study eye. (fovea or parafovea);
- Central retinal thickness (CRT) of the study eye \>300 μm (or \>320 μm for Heidelberg OCT) as assessed by central image review during screening;
- Best-corrected visual acuity (BCVA) of the study eye between 73 and 21 letters (using ETDRS chart, including boundary values; equivalent to Snellen visual acuity scores of 20/40 to 20/400);
- Contralateral eye BCVA \> 24 letters (using ETDRS chart, equivalent to Snellen acuity 20/320); Note: If both eyes meet , the eye with poorer BCVA is selected as the study eye, unless the investigator determines the...
What rules you out
- Patients meeting any of the following criteria will be excluded from this study:
- Presence of structural damage in the central macula of the study eye that may prevent improvement in best-corrected visual acuity after resolution of macular edema, including retinal pigment epithelial cell atrophy...
- Presence of any condition in the study eye other than diabetic macular edema that may confound fundus evaluation or visual acuity testing (e.g., retinal vascular occlusion, retinal detachment, optic nerve ischemia...
- Aphakia in the study eye or presence of an intraocular lens with posterior capsule opacification (exemption granted for posterior capsule opacification resulting from YAG capsulotomy, provided a 1-month washout period...
- The study eye has uncontrolled glaucoma (intraocular pressure \>25 mmHg despite antiglaucoma medication); or a history of glaucoma filtration surgery; or plans for antiglaucoma surgery during the study period;
- The study eye has undergone vitreoretinal surgery or scleral buckling;
- The study eye has undergone panretinal photocoagulation (PRP) or focal/grid PRP in the macular area within the preceding 3 months, or there is a possibility of undergoing PRP during the study period;
- Presence of neovascular glaucoma, iris neovascularization, or other clinically significant iris lesions deemed abnormal by the investigator in the study eye;
- Active proliferative diabetic retinopathy (PDR) in the study eye, characterized by fibrovascular proliferation, vitreous hemorrhage, and retinal detachment;
- The study eye has undergone intraocular surgery within the past 3 months, or is scheduled to undergo intraocular surgery during the study period;
- The study eye has refractive media opacities (e.g., corneal scarring, undilatable pupils, cataracts, vitreous hemorrhage) that interfere with visual acuity assessment or fundus examination;
- The study eye has received intravitreal injection of long-acting or sustained-release corticosteroids (e.g., dexamethasone intravitreal implant) or high-dose oral corticosteroids (\>10 mg prednisolone or equivalent...
- The equivalent spherical refractive error of the study eye exceeds -6.0 diopters. For patients with a history of refractive or cataract surgery, the refractive error of the study eye should not exceed -6.0 diopters...
- History of uveitis in either eye;
- Active ocular inflammation or infection (bacterial, viral, parasitic, or fungal) in either eye;
- Receipt of anti-VEGF therapy in the study eye or systemic administration within 90 days (inclusive) prior to randomization; Exclusion Criteria for Abnormal Laboratory Findings:
- Abnormal liver or renal function (defined in this trial as ALT and AST not exceeding 2.5 times the upper limit of normal for this center's laboratory; Crea and BUN not exceeding 2 times the upper limit of normal for...
- Coagulation abnormalities (prothrombin time \> 3 seconds above the upper limit of normal, activated partial thromboplastin time \> 10 seconds above the upper limit of normal);
- Patients with any active infection: positive hepatitis B screening (defined as positive hepatitis B surface antigen and HBV-DNA \> 1000 IU/mL or the hospital's maximum cutoff value), Positive screening for hepatitis C...
- Acute cardiovascular or cerebrovascular disease, related treatment, or other thromboembolic disorders within 6 months prior to first dosing;
- Poorly controlled diabetes or glycated hemoglobin (HbA1c) \>11%;
- Uncontrolled hypertension (defined as blood pressure \>160/95 mmHg despite antihypertensive medication);
- Undergone surgery within the past month with unhealed wounds, or as determined by the investigator;
- Diagnosed systemic autoimmune disease (e.g., ankylosing spondylitis, systemic lupus erythematosus) or any uncontrolled clinical condition (e.g., malignancy, active hepatitis, severe psychiatric, neurological...
- History of conditions contraindicated for the study drug, metabolic dysfunction, physical examination findings, or diseases/symptoms reasonably suspected based on clinical laboratory results that are contraindications...
- Known allergy or contraindication to the study drug or its components, fluorescein, povidone-iodine, or indocyanine green;
- Participation in any drug clinical trial (excluding vitamins and minerals) within 90 days prior to the first study dose (calculated from the last dose of the investigational drug; if the investigational drug has a long...
- Pregnant, pregnant women, or lactating women (pregnancy defined in this trial as a positive blood/urine pregnancy test); Male or female people of reproductive potential who refuse to use appropriate contraception (e.g...
- Other conditions deemed by the investigator to warrant exclusion.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Lanzhou, Gansu, China
- Guangzhou, Guangdong, China
- Shantou, Guangdong, China
- Shenzhen, Guangdong, China
- Nanning, Guangxi, China
- Zunyi, Guizhou, China
- Cangzhou, Hebei, China
- Shijiazhuang, Hebei, China
- Xingtai, Hebei, China
- Luoyang, Henan, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
- Wuxi, Jiangsu, China
- Changchun, Jilin, China
- Panjin, Liaoning, China
- Shenyang, Liaoning, China
+ 12 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 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Lanzhou, Gansu, China; Guangzhou, Guangdong, China; Shantou, Guangdong, China; Shenzhen, Guangdong, China and 26 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.