Diabetic Macular Edema
Conditions
Keywords
DME
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 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.
Interventions
DRUG2.5mg of BAT5906
Specification: 2.5mg of BAT5906
DRUG4.0mg of BAT5906
Specification: 4.0mg of BAT5906
Sponsors
Bio-Thera Solutions
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
one investigational medicine with two different dose groups
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Only the following criteria are met: 1. Sign the informed consent voluntarily, willing and capable to follow the procedures of outpatient visits and research at the time specified in the trial 2. Diagnosed with type 1 or type 2 diabetes, aged 18 to 80 years old; 3. The drug treatment to control diabetes must be stable within 3 months before randomization and is expected to remain stable during the study period; 4. 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; 5. The study eye is assessed by OCT with CRT ≥ 250 µm; 6. BCVA in the study eye is 73 to 21 letters (using the ETDRS chart, inclusive of boundary values, equivalent to a Snellen visual acuity score of 20/40 to 20/400 in the study eye). 7. BCVA in the fellow eye is ≥24 letters (using the ETDRS chart, equivalent to Snellen visual acuity ≥20/320). Note: If both eyes meet the inclusion criteria, the eye with the worse baseline visual acuity will be selected as the study eye. 8. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1.1 Safety evaluation - Vital signs# the patient's body temperature； | Day-14~Day-1；Day0；Day28；Day56；Day84；Day112；Day140；Day168；Day196；Day224；Day252；Day280；Day308；Day336 | the patient's body temperature (axillary temperature) Any clinically significant abnormality should be reported as an adverse event and recorded in the original |
| 1.2 Safety evaluation - Vital signs# heart rate/pulse | Day-14~Day-1；Day0；Day28；Day56；Day84；Day112；Day140；Day168；Day196；Day224；Day252；Day280；Day308；Day336 | heart rate/pulse Any clinically significant abnormality should be reported as an adverse event and recorded in the original |
| 1.3 Safety evaluation - Vital signs# respiratory rate | Day-14~Day-1；Day0；Day28；Day56；Day84；Day112；Day140；Day168；Day196；Day224；Day252；Day280；Day308；Day336 | respiratory rate Any clinically significant abnormality should be reported as an adverse event and recorded in the original |
| 1.4 Safety evaluation - Vital signs# blood pressure | Day-14~Day-1；Day0；Day28；Day56；Day84；Day112；Day140；Day168；Day196；Day224；Day252；Day280；Day308；Day336 | blood pressure Any clinically significant abnormality should be reported as an adverse event and recorded in the original |
| 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) | Day-14~Day-1；Day84；Day168；Day336 | Full physical examination including general appearance, skin, pulmonary, cardiac, abdominalextremity and musculoskeletal assessments will be performed per study evaluation schedule. Allclinically significant abnormalities relative to baseline screening physical exam findings will bedocumented as adverse events. The primary summary metric is the proportion and number ofsubjects presenting 21 clinically significant abnormal physical examination finding during on-treatment study visits. |
| Number of participants with clinically significant abnormal laboratory findings | Day-14~Day-1；Day84；Day168；Day336 | Laboratory examinations include complete blood count, urinalysis, blood biochemistry (including liver and renal function), and coagulation function. Clinically significant changes from baseline will be assessed and reported as adverse events (AEs) based on CTCAE v4.0 criteria. |
| Number of participants with clinically significant abnormal ECG findings | Day-14~Day-1；Day84；Day168；Day336 | The 12-lead ECG will be performed to measure parameters including heart rate, PR interval, QRS duration, and QT/QTc interval. Clinically significant changes from baseline will be assessed by the investigator and recorded as adverse events |
| Anti-drug antibody (ADA); | 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) | 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) | 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. |
| Efficacy evaluation | at Week 36 | 2.1 Primary efficacy endpoint (study eye):Change from baseline in BCVA |
| Pharmacokinetic (PK) Evaluation | Once within 24 hours before administration.6 hours after administration, 24 hours after administration(once every 3 days) up to 672 hours after administration | Blood samples were collected from each treatment group throughout the study to determine the serum concentration of BAT5906 Injection. The PK blood sample collection schedule is detailed in the PK/VEGF/ADA Blood Collection Schedule. |
| Peripheral Blood VEGF Assessment (VEGF) | Once within 24 hours before administration.24 hours after administration (once every 7 days) up to 672hours after administration | lood samples were collected from each treatment group throughout the study to measure blood VEGF concentrations. The blood sample collection schedule is detailed in the PK/VEGF/ADA Blood Sampling Schedule |
| Immunogenicity Assessment | 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 | Anti-BAT5906 antibodies (ADA) were detected. The blood sample collection schedule is detailed in the PK/VEGF/ADA Blood Sampling Schedule. Anti-drug antibodies (ADA) in serum were detected; samples confirmed positive for ADA were subsequently analyzed for neutralizing antibodies (Nab) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1、Efficacy evaluation | at Weeks 12, 24, and 48 | 1.1 Change from baseline in BCVA 1.2 Change from baseline in CRT as assessed by OCT 1.3 Proportion of subjects with a ≥10-letter gain from baseline in BCVA, a ≥15-letter gain from baseline in BCVA, and a ≥15-letter loss from baseline in BCVA 1.4 Mean number of BAT5906 injections administered |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORYouxin Chen
Peking Union Medical College
Outcome results
None listed