Phase Ib/IIa Clinical Study of the Safety and Efficacy of BAT5906 Injection in Patients With Diabetic Macular Edema With Multiple Changes of Intravitreal Two Doses
Overview
- Phase
- Phase 1
- Intervention
- 2.5mg of BAT5906
- Conditions
- Diabetic Macular Edema
- Sponsor
- Bio-Thera Solutions
- Enrollment
- 60
- Locations
- 19
- Primary Endpoint
- Vital signs（ body temperature）
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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 effect for longer; 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Only the following criteria are met:
- •Sign the informed consent voluntarily, willing and capable to follow the procedures of outpatient visits and research at the time specified in the trial
- •Diagnosed with type 1 or type 2 diabetes, aged 18 to 80 years old;
- •The drug treatment to control diabetes must be stable within 3 months before randomization and is expected to remain stable during the study period;
- •Macular edema secondary to diabetes, and found to be involved in the macular center (fovea) of the research eye by OCT examination, confirmed by the reading center during screening;
- •The CRT of the research eye evaluated by OCT examination is ≥300 μM, confirmed by the reading center during screening;
- •The BCVA of the research eye is 73-24 letters (using the ETDRS table, including the boundary value, which is equivalent to the Snellen visual acuity score of the research eye equal to 20/40 -20/400);
- •Contralateral eye BCVA ≥ 34 letters (using ETDRS table, equivalent to snellen vision ≥ 20/200). Note: If both eyes meet the inclusion criteria, the eye with poor baseline vision is selected as the research eye;
- •At the time of screening and baseline, the investigator judged that the contralateral eye was expected to not require any anti-VEGF treatment within 3 months (PK group only).
Exclusion Criteria
- •If a patient meets any of the following conditions, they cannot enter the study:
- •Eye exclusion criteria:
- •There is structural damage to the center of the macula in the eye, and the best corrected vision may not be improved after the macular edema resolves, including atrophy of retinal pigment epithelial cells, subretinal fibrosis or scarring, and obvious macular ischemia (FFA suggests arching Obvious damage), macular anterior membrane involving fovea or organic hard exudate (as confirmed by the reading center before randomization);
- •The research eye has iris lesions and neovascular glaucoma;
- •Those who have no eye lens (except intraocular lens);
- •The study eye has active hyperplastic diabetic retinopathy (PDR);
- •The research eye has anyone other than diabetic macular edema that may confuse macular assessment or vision testing (retinal vascular occlusion, retinal detachment, vitreous macular traction, macular hole, preretinal fibrosis involving the macula, choroidal neovascularization, age Related macular degeneration, etc.);
- •The research eye is accompanied by poorly controlled glaucoma, which is defined as the intraocular pressure still ≥21mmHg after treatment with anti-glaucoma drugs, or according to the judgment of the investigator;
- •The research eye has undergone or may have undergone anti-glaucoma surgery during the study period (including trabeculectomy, sclerectomy and non-penetrating trabecular surgery, etc.);
- •The research eye has undergone vitreoretinal surgery or scleral buckling;
Arms & Interventions
2.5mg of BAT5906
Specification: 10mg/0.2ml/piece; route of administration: intravitreal injection; dose: 2.5mg/eye/time, 50μl; medication duration: once every 4 weeks, 6 consecutive times, then every 4 weeks Followed up once (the investigator judged to administer the drug as needed) and observed until the 48th week.
Intervention: 2.5mg of BAT5906
4mg of BAT5906
Specification: 16mg/0.2ml/piece; route of administration: intravitreal injection; dose: 4mg/eye/time, 50μl; medication duration: once every 4 weeks, 3 consecutive times, then every 4 weeks Followed up once (the investigator judged to administer the drug as needed) and observed until the 48th week.
Intervention: 4.0mg of BAT5906
Outcomes
Primary Outcomes
Vital signs（ body temperature）
Time Frame: After patient resting for more than 3 minutes
the patient's body temperature (axillary temperature) Any clinically significant abnormality should be reported as an adverse event and recorded in the original
physical examination
Time Frame: The investigator or other authorized and qualified investigator shall perform the prescribed physical examination according to the evaluation schedule. During the visit, the investigator performed a physical examination as indicated by symptoms
Physical examination should include at least general conditions, head and face, skin, lymph nodes, ears, nose, throat, respiratory system, cardiovascular system, abdomen (including liver and spleen), genitourinary system, musculoskeletal system, nervous system, and mental condition
laboratory examination（blood coagulation function）
Time Frame: Screening period，Week 12, Week 24, Week 48 of the last visit
In the test process will be carried out in accordance with the testing program flow chart of blood coagulation function, the laboratory testing results of the subjects to evaluate the change of relative to the baseline, the each evaluate clinical significance of abnormal experimental value, the researchers don't think with basic diseases related to abnormal subjects as AE record
electrocardiogram（12- Lead ECG）
Time Frame: Screening period of the first visit: Week 12 of the fifth visit, Week 24 of the eighth visit, and Week 48 of the last visit
During the trial, the examination of the electrocardiogram (ecg) method must be consistent, and to evaluate the clinical significance of the results, will any researchers to make judgment for clinical significance of abnormal as adverse events were reported, and recorded in the original records and case report form, the subjects in the process of the entire study if there is clinical indications by researchers to determine whether the need for ecg examination.
anti-drug antibody (ADA)
Time Frame: 24 hours before 1, 2, 3, 4 dosing, 5 dosing to last visit, each dosing before and 24 hours before the last visit as needed
Plasma samples for anti-drug antibody (ADA) detection were collected to detect the positive incidence of ADA associated with plasma levels of BAT5906
ocular and non-ocular adverse events (AE) and serious adverse events (SAE)
Time Frame: Adverse events were collected from the time the patient signed the informed consent to the time 28 days after the last dication
Any adverse medical event that occurs after a subject participates in a clinical trial and receives the investigational drug, but is not necessarily cause-and-effect with the treatment. An adverse event can be any adverse or unexpected sign (including abnormal laboratory tests), symptom, or disease, whether or not it is drug related.
laboratory examination（blood routine）
Time Frame: Screening period，Week 12, Week 24, Week 48 of the last visit
In the test process will be carried out in accordance with the testing program flow chart of blood routine, the laboratory testing results of the subjects to evaluate the change of relative to the baseline, the each evaluate clinical significance of abnormal experimental value, the researchers don't think with basic diseases related to abnormal subjects as AE record
Vital signs（heart rate/pulse）
Time Frame: After patient resting for more than 3 minutes
heart rate/pulse Any clinically significant abnormality should be reported as an adverse event and recorded in the original
Vital signs（respiratory rate）
Time Frame: After patient resting for more than 3 minutes
respiratory rate Any clinically significant abnormality should be reported as an adverse event and recorded in the original
Vital signs（blood pressure）
Time Frame: After patient resting for more than 3 minutes
blood pressure Any clinically significant abnormality should be reported as an adverse event and recorded in the original
laboratory examination（outine urine）
Time Frame: Screening period，Week 12, Week 24, Week 48 of the last visit
In the test process will be carried out in accordance with the testing program flow chart of routine urine , the laboratory testing results of the subjects to evaluate the change of relative to the baseline, the each evaluate clinical significance of abnormal experimental value, the researchers don't think with basic diseases related to abnormal subjects as AE record
laboratory examination（blood biochemical examination）
Time Frame: Screening period，Week 12, Week 24, Week 48 of the last visit
In the test process will be carried out in accordance with the testing program flow chart of blood biochemical examination, the laboratory testing results of the subjects to evaluate the change of relative to the baseline, the each evaluate clinical significance of abnormal experimental value, the researchers don't think with basic diseases related to abnormal subjects as AE record
Secondary Outcomes
- Effectiveness evaluation(24 weeks and 48 weeks)