This study is a multi-center, open, multiple-dose phase Ib/IIa clinical study evaluating the efficacy and safety of BAT5906 injection in patients with diabetic macular edema. BAT5906's phase I study on w-AMD shows that it is safe from 0.3-4.0 mg, and the higher dose (2.5 mg and 4 mg) may maintain the anti-VEGF effect for a longer time just like the same target drugs (such as brolucizumab and Abecip ) It has also been found in clinical studies that high doses can extend the dosing interval and reduce the dosing frequency. Therefore, in this study, two safe and effective doses were selected, and the optimal clinical effective dose and frequency of BAT5906 in DME were initially explored.
Age range
18 Years – 80 Years
Sex
ALL
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Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
1.1 Safety evaluation - Vital signs# the patient's body temperature;
Timeframe: Day-14~Day-1;Day0;Day28;Day56;Day84;Day112;Day140;Day168;Day196;Day224;Day252;Day280;Day308;Day336
1.2 Safety evaluation - Vital signs# heart rate/pulse
Timeframe: Day-14~Day-1;Day0;Day28;Day56;Day84;Day112;Day140;Day168;Day196;Day224;Day252;Day280;Day308;Day336
1.3 Safety evaluation - Vital signs# respiratory rate
Timeframe: Day-14~Day-1;Day0;Day28;Day56;Day84;Day112;Day140;Day168;Day196;Day224;Day252;Day280;Day308;Day336
1.4 Safety evaluation - Vital signs# blood pressure
Timeframe: Day-14~Day-1;Day0;Day28;Day56;Day84;Day112;Day140;Day168;Day196;Day224;Day252;Day280;Day308;Day336
Number of subjects with clinically significant abnormal physical examination signs identified byprotocol-specified full physical examination (general appearance, skin, lungs, heart, abdomen,extremities, musculoskeletal system)
Timeframe: Day-14~Day-1;Day84;Day168;Day336
Number of participants with clinically significant abnormal laboratory findings
Timeframe: Day-14~Day-1;Day84;Day168;Day336
Number of participants with clinically significant abnormal ECG findings
Timeframe: Day-14~Day-1;Day84;Day168;Day336
Anti-drug antibody (ADA);
Timeframe: Screening (within 24 hours prior to first dose), Day 7 (168h), Day 14 (336h), prior to the 3rd dose (within 24 hours), and prior to the 5th dose through end of study visit (as needed)
ocular and non-ocular adverse events (AE) and serious adverse events (SAE)
Timeframe: Adverse events were collected from the time the patient signed the informed consent to the time 28 days after the last dication
Efficacy evaluation
Timeframe: at Week 36
Pharmacokinetic (PK) Evaluation
Timeframe: Once within 24 hours before administration.6 hours after administration, 24 hours after administration(once every 3 days) up to 672 hours after administration
Peripheral Blood VEGF Assessment (VEGF)
Timeframe: Once within 24 hours before administration.24 hours after administration (once every 7 days) up to 672hours after administration
Immunogenicity Assessment
Timeframe: First administration: within 24 hours prior to administration.168 hours and 336 hours after administration,and the second until the last administration: within 24 hours before administration