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Diabetic Macular EdemaPhase 1/2NCT04772105

Study of Two Multiple Intravitreal Doses of BAT5906 for Safety and Efficacy in Patients With Diabetic Macular Edema

A Phase 1/2 study testing 2.5mg of BAT5906 and 4.0mg of BAT5906 in people with Diabetic Macular Edema, run by Bio-Thera Solutions at 19 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Diabetic Macular Edema
What is being tested?
2.5mg of BAT5906 and 4.0mg of BAT5906
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
19 sitesChina
Study dates
16 Oct 2020to 6 Nov 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 study eye is assessed by OCT with CRT ≥ 250 µm;
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  • 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).
  • 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.
  • 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).

Who cannot join

  • 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);
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  • 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;
  • At the time of screening and baseline, the study eye had received laser photocoagulation (total retina or macular laser photocoagulation) within 90 days (including 90 days) or during the study period;
  • At the time of screening and baseline, the study eye had any intraocular or perocular surgery within 90 days (including 90 days) (except for yttrium-aluminum-garnet (YAG) lens capsule incision and eyelid surgery for more than 30 days) ;
  • A history of uveitis in any eye;
  • Any eye has active ocular inflammation or infection (bacterial, viral, parasitic or fungal infection);
  • At the time of screening and baseline, any eye had received intraocular anti-VEGF treatment within the first 90 days (including 90 days), such as ranibizumab, bevacizumab, abercept, compacept, etc.;
  • At the time of screening and baseline, any eye has received intraocular, periocular, and subconjunctival corticosteroid treatment within the first 90 days (including 90 days);
  • Exclusion criteria for abnormal conditions in laboratory inspection:
  • Abnormal liver and kidney function (this test specifies that ALT and AST should not be higher than the upper limit of the normal value of the laboratory in the center by 2.5 times; Crea and BUN should not be higher than the upper limit of the normal value of the laboratory in the center by 2 times);
  • Abnormal blood coagulation function (prothrombin time ≥ upper limit of normal value 3 seconds, activated partial thromboplastin time ≥ upper limit of normal value 10 seconds);
  • Any one of the infected patients: active hepatitis B (if HBsAg(+) requires HBV DNA must be> 500 IU/mL or the hospital maximum limit), hepatitis C, AIDS or syphilis (positive RPR test);
  • Other exclusion criteria:
  • Myocardial infarction or stroke occurred within 6 months before the first dose;
  • Poorly controlled diabetes mellitus [defined as glycosylated hemoglobin (HbA1c) > 10%];
  • Accompanied by uncontrollable hypertension (defined as blood pressure >150/100 mmHg after treatment with antihypertensive drugs);
  • Patients who took large doses of oral or injectable corticosteroids and other hormonal drugs (>10 mg prednisolone or the same dose/day) within 6 months before screening, but patients who used steroid drugs for inhalation, nasal cavity or local skin small doses except;
  • Those who have undergone surgery within 1 month and have not healed, or according to the investigator's judgment;
  • There is a history of contraindications to the study drug, metabolic dysfunction, physical examination results, or a disease or symptom that is reasonably suspected of being based on clinical laboratory results is a contraindication to the study drug, which may affect the judgment of the study results, or make the subject suffer Higher risk of complications;
  • Allergy or contraindications to known research drugs or their ingredients, fluorescein or povidone iodine;
  • Those who participated in clinical trials of any drugs (except vitamins and minerals) or devices 90 days before the first dose (including 90 days);
  • Women who are pregnant, pregnant or breastfeeding (pregnancy is defined as a positive blood/urine pregnancy test in this trial); male or female subjects of fertility do not agree to the entire study period and within 3 months after the end of the visit period Take appropriate contraceptive measures (such as IUD, birth control pills or condoms, etc.). For women who have not been menopausal or have been menopausal but have not met the menopause time continuously for more than 12 months, and have not undergone sterilization surgery (ovarian and/or hysterectomy), they are defined as having fertility. The definition of fertility may be adjusted according to local standards in each region.
  • Note: High-efficiency contraception methods include total abstinence, IUD, double barrier method (eg condom + diaphragm with spermicides, implanted contraceptives, hormonal contraceptives [contraceptives, implanted contraceptives, transdermal Patches, hormone-vaginal devices or sustained-release injections], or the partner has undergone a vasectomy and is confirmed to have no sperm);
  • The researchers believe that there are other conditions that need to be excluded.

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

China19 sites

  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

    Beijiang, Beijing Municipality, 100730

  • Eye Hospital of China Academy of Chinese Medical Sciences

    Beijing

  • Peking University First Hospital

    Beijing

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou

  • Zhejiang Provincial People's Hospital

    Hangzhou

  • Henan Provincial Eye Hospital

    Henan

  • Jieyang People's Hospital

    Jieyang

  • The First Hospital of Jilin University

    Jilin City

  • The Affiliated Eye Hospital of Nanchang University

    Nanchang

  • Jiangsu Provincial Hospital of Traditional Chinese Medicine

    Nanjing

  • Affiliated Hospital of Nantong University

    Nantong

  • Affiliated Hospital of Qingdao University

    Qingdao

  • Joint Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong

    Shantou

  • West China Hospital of Sichuan University

    Sichuan

  • Wenzhou Medical University Affiliated Optometry Hospital

    Wenzhou

  • The Second Xiangya Hospital of Central South University

    Xiangya

  • Xiangya Hospital Central South University

    Xiangya

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

Other trials in China

About this study

Official title: Phase Ib/IIa Study to Evaluate the Safety and Efficacy of Intravitreal Administration of Two Doses of BAT5906 Injection With Multiple Dosing Regimens in Patients With Diabetic Macular Edema

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.

Being tested
2.5mg of BAT5906, 4.0mg of BAT5906
Keywords
DME

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 2.5mg of BAT5906Drug

    Specification: 2.5mg of BAT5906

  • 4.0mg of BAT5906Drug

    Specification: 4.0mg of BAT5906

Study groups in NCT04772105
Study groupRoleWhat they receive
2.5mg of BAT5906ExperimentalSpecification: 10 mg/0.2 mL per vial Route of Administration: Intravitreal Injection Dose: 2.5 mg per eye per administration (50 μL) Treatment Regimen: One injection every 4 weeks for 6 consecutive administrations; follow-up visits will be conducted every 4 weeks thereafter, with PRN retreatment permitted at the investigator's discretion, and subjects will be followed up until Week 48.
Receives: Drug: 2.5mg of BAT5906
4mg of BAT5906ExperimentalSpecification: 16 mg/0.2 mL per vial； Route of Administration: Intravitreal Injection； Dose: 4 mg per eye per administration (50 μL)； Treatment Regimen: One injection every 4 weeks for 3 consecutive administrations; follow-up visits will be conducted every 4 weeks thereafter, with PRN retreatment permitted at the investigator's discretion, and subjects will be followed up until Week 48.
Receives: Drug: 4.0mg of BAT5906

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1.1 Safety evaluation - Vital signs# the patient's body temperature；

    the patient's body temperature (axillary temperature) Any clinically significant abnormality should be reported as an adverse event and recorded in the original

    Measured: Day-14~Day-1；Day0；Day28；Day56；Day84；Day112；Day140；Day168；Day196；Day224；Day252；Day280；Day308；Day336

  2. 1.2 Safety evaluation - Vital signs# heart rate/pulse

    heart rate/pulse Any clinically significant abnormality should be reported as an adverse event and recorded in the original

    Measured: Day-14~Day-1；Day0；Day28；Day56；Day84；Day112；Day140；Day168；Day196；Day224；Day252；Day280；Day308；Day336

  3. 1.3 Safety evaluation - Vital signs# respiratory rate

    respiratory rate Any clinically significant abnormality should be reported as an adverse event and recorded in the original

    Measured: Day-14~Day-1；Day0；Day28；Day56；Day84；Day112；Day140；Day168；Day196；Day224；Day252；Day280；Day308；Day336

  4. 1.4 Safety evaluation - Vital signs# blood pressure

    blood pressure Any clinically significant abnormality should be reported as an adverse event and recorded in the original

    Measured: Day-14~Day-1；Day0；Day28；Day56；Day84；Day112；Day140；Day168；Day196；Day224；Day252；Day280；Day308；Day336

  5. 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)

    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.

    Measured: Day-14~Day-1；Day84；Day168；Day336

  6. Number of participants with clinically significant abnormal laboratory findings

    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.

    Measured: Day-14~Day-1；Day84；Day168；Day336

  7. Number of participants with clinically significant abnormal ECG findings

    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

    Measured: Day-14~Day-1；Day84；Day168；Day336

  8. Anti-drug antibody (ADA);

    Plasma samples for anti-drug antibody (ADA) detection were collected to detect the positive incidence of ADA associated with plasma levels of BAT5906

    Measured: 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)

  9. ocular and non-ocular adverse events (AE) and serious adverse events (SAE)

    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.

    Measured: Adverse events were collected from the time the patient signed the informed consent to the time 28 days after the last dication

  10. Efficacy evaluation

    2.1 Primary efficacy endpoint (study eye):Change from baseline in BCVA

    Measured: at Week 36

  11. Pharmacokinetic (PK) Evaluation

    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.

    Measured: Once within 24 hours before administration.6 hours after administration, 24 hours after administration(once every 3 days) up to 672 hours after administration

  12. Peripheral Blood VEGF Assessment (VEGF)

    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

    Measured: Once within 24 hours before administration.24 hours after administration (once every 7 days) up to 672hours after administration

  13. Immunogenicity Assessment

    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)

    Measured: 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

Secondary outcomes (1)

  1. 1、Efficacy evaluation

    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

    Measured: at Weeks 12, 24, and 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2021
  2. Study start16 Oct 2020
  3. Primary completion6 Nov 2023
  4. Study completion6 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
one investigational medicine with two different dose groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04772105
Sponsor's protocol ID
BAT5906-003-CR
Status last verified
Apr 2024
First submitted
22 Jun 2020
Last updated
14 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 2.5mg of BAT5906 and 4.0mg of BAT5906 in people with Diabetic Macular Edema, run by Bio-Thera Solutions at 19 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1.1 Safety evaluation - Vital signs# the patient's body temperature； (time frame: Day-14~Day-1；Day0；Day28；Day56；Day84；Day112；Day140；Day168；Day196；Day224；Day252；Day280；Day308；Day336). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04772105.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.

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