AzTrials
AzTrials

Wet Age-related Macular DegenerationPhase 2NCT05141994

Clinical Study on the Efficacy and Safety of BAT5906 Injection

A Phase 2 study testing 2.5mg of BAT5906 and 4mg of BAT5906 in people with Wet Age-related Macular Degeneration, run by Bio-Thera Solutions at 16 sites in China.

Completed

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

Official record
Search all trials

Trial summary

This study is a multi-center, open, and phase II clinical study to evaluate the efficacy and safety of BAT5906 injection in patients with wet age-related macular degeneration. The results of the BAT5906 Phase I study show that it is safe from 0.3-4.0 mg, and that higher doses (2.5 mg and 4 mg) may be substituted for… Read more about this study

Who is it for?
Ages 50 to 85 years
Conditions the study is for
Wet Age-related Macular Degeneration
What is being tested?
2.5mg of BAT5906 and 4mg of BAT5906
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
16 sitesChina
Study dates
26 Aug 2020to 6 Sep 2022
Phase
Phase 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 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Only the following criteria are met:
  • The patient or his legal representative authorized by the patient signs the informed consent, fully understands the test content, process and possible adverse reactions, and is willing to follow up within the time specified in the test;
  • Age 50-85 years old (including boundary value), male or female;
  • The patient diagnosed with active choroidal neovascularization (CNV) disease secondary to wet age-related macular degeneration is confirmed by the reading center during screening;
  • The total area of research eye lesions ≤ 30mm2 (12 optic disc areas), confirmed by the reading center before random enrollment;
  • At the time of screening and baseline, the BCVA of the study eye was 73-24 letters (using the ETDRS visual acuity table, including the boundary value) (equivalent to the snellen visual acuity score of the study eye of 20/40 to 20/400);
  • At the time of screening and baseline, the contralateral eye BCVA ≥ 34 letters (using the ETDRS visual acuity table, which is equivalent to snellen vision ≥ 20/200). For the subjects in the PK group, the investigator must judge that the contralateral eye is expected to be 3 No anti-VEGF treatment is required within a month.

Who cannot join

  • If a patient meets any of the following conditions, they cannot enter the study:
  • Those with the following eye conditions:
  • The research eye has map-like atrophy involving the fovea, scars or fibrosis, anterior macular membrane, dense exudate hard exudation, RPE tear, etc. (confirmed by the reading center during screening);
  • Research eye retinal hemorrhage ≥ 4 optic disc areas (confirmed by the reading center during screening);
  • The research eye has significant interference with vision detection, anterior segment and fundus assessment of the refractive medium is turbid or the pupil is not dilated;
  • The research eye is combined with other fundus diseases (such as diabetic retinal degeneration, retinal vein occlusion, vascular streaking, pathological myopia, retinal detachment, macular hole, toxoplasmosis, optic nerve disease, etc.);
Show all 41Show fewer
  • The research eye has pupil afferent defects (APD)
  • There are uncontrolled glaucoma in the research eye at the time of screening and baseline, defined as the intraocular pressure is still higher than 21mmHg after drug treatment, or according to the investigator's judgment;
  • The pre-screening research eye had received dexamethasone intravitreal implant (Ozurdex) treatment or fluocinolone intravitreal implant (Iluvien) treatment;
  • Within 3 months before the screening, the research eye had received the following treatments: photodynamic therapy (PDT), total retina laser photocoagulation, macular laser photocoagulation, transpupillary thermotherapy, etc., for AMD therapy;
  • The research eye has undergone the following ophthalmic operations: vitrectomy, macular transposition, anti-glaucoma surgery;
  • Have undergone external eye surgery or cataract surgery within 3 months before the study eye screening or during the study period;
  • The study eye has no lens (excluding intraocular lens) or posterior lens capsule rupture (except YAG laser posterior capsulotomy after implantation of intraocular lens more than 1 month after screening);
  • Contralateral eye received photodynamic (PDT) treatment within 1 month before screening;
  • A history of uveitis in any eye;
  • Vitreous hemorrhage in any eye during the screening period or history of vitreous hemorrhage within 4 weeks before baseline;
  • Any eye has pseudocapsular exfoliation syndrome;
  • Any eye has active eye infection (eg: blepharitis, infectious conjunctivitis, keratitis, scleritis, iridocyclitis, endophthalmitis);
  • Within 3 months before the screening, any eye had received intravitreal injection of anti-VEGF drugs (such as abecept, compaq, ranibizumab, bevacizumab, etc.);
  • Injection of corticosteroid drugs (such as triamcinolone acetonide, dexamethasone, etc.) into any eye, periocular or subconjunctival eye within 3 months before screening;
  • Those with any of the following general conditions:
  • Currently in use or may need to use systemic drugs that may cause crystal toxicity or retinal toxicity, such as deferoxamine, chloroquine/hydroxychloroquine, phenothiazine, ethambutol or tamoxifen, etc.;
  • Have an allergic reaction or history of fluorescein sodium and indocyanine green, have a history of allergy to protein products for treatment or diagnosis, or are known to have allergic reactions to any monoclonal antibody;
  • Previously received systemic anti-VEGF treatment;
  • Patients with 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 use steroid drugs for inhalation, nasal cavity or local skin small doses except;
  • Poorly controlled diabetic patients are defined as glycated hemoglobin> 10%;
  • Those who had surgery within 1 month before screening and did not heal, or according to the judgment of the investigator;
  • There are clinically significant systemic infectious diseases that require intravenous antibiotic therapy;
  • Those who have a history of myocardial infarction, cerebral infarction and angina within 6 months before screening;
  • Those who have active disseminated intravascular coagulation and obvious bleeding tendency within 3 months before screening, or have received anticoagulant and antiplatelet therapy except aspirin/NSAIDs within 14 days before screening;
  • Hypertension patients with poor control (defined as blood pressure >160/100 mmHg after treatment with antihypertensive drugs);
  • Any uncontrollable clinical problems (such as severe mental, neurological, cardiovascular, respiratory and other system diseases and malignant tumors);
  • Those with abnormalities in any of the following laboratory tests:
  • Abnormal liver and kidney function (this test stipulates that ALT and AST shall not be higher than the upper limit of the normal value of the laboratory in the center by 2.5 times; Crea and BUN shall not be higher than the upper limit of the normal value of the laboratory in the center by 2 times);
  • Patients with abnormal blood coagulation function (prothrombin time> upper limit of normal value 3 seconds or activated partial thromboplastin time> upper limit of normal value 10 seconds);
  • Any one of the following 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 (syphilis RPR positive test) ;
  • Women and men of childbearing age in any of the following situations:
  • 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 IUDs, 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 appliances or sustained-release injections], or the partner has undergone vasectomy and is confirmed to have no sperm); other:
  • Those who have participated in clinical trials of any drugs (excluding vitamins and minerals) within 3 months before screening;
  • The researchers believe that those who need to be excluded.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

China16 sites

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

    Beijing, 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

  • Zhejiang Provincial People's Hospital

    Hangzhou

  • Jieyang People's Hospital

    Jieyang

  • The First Hospital of Jilin University

    Jilin City

  • he Affiliated Eye Hospital of Nanchang University

    Nanchang

  • Jiangsu Provincial Hospital of Traditional Chinese Medicine

    Nanjing

  • The 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

  • Henan Provincial Eye Hospital

    Zhengzhou

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

Other trials in China

About this study

Official title: Phase II Clinical Study on the Efficacy and Safety of BAT5906 Injection in the Vitreous Age-related Macular Degeneration Patients With Two Repeated Intravitreal Dose

This study is a multi-center, open, and phase II clinical study to evaluate the efficacy and safety of BAT5906 injection in patients with wet age-related macular degeneration. The results of the BAT5906 Phase I study show that it is safe from 0.3-4.0 mg, and that higher doses (2.5 mg and 4 mg) may be substituted for the duration of maintenance efficacy; drugs with the same target (such as brolucizumab and Abecip) have also been found in clinical studies High doses can extend the interval and reduce the frequency of administration. Therefore, in this study, two doses with better safety and efficacy were selected, once every 4 weeks, followed by 3 consecutive injections for treatment as needed, and preliminary exploration of the best clinical effective dose and replacement frequency

Being tested
2.5mg of BAT5906, 4mg of BAT5906

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

  • 4mg of BAT5906Drug

    Specification: 4mg of BAT5906

Study groups in NCT05141994
Study groupRoleWhat they receive
2.5mg of BAT5906ExperimentalSpecification: 10mg/0.2ml/piece; route: intravitreal injection; dose: 2.5mg/eye/time, 50μl; medication duration: about once every 4 weeks, taking 3 times after continuous use, effective observation to Week 48.
Receives: Drug: 2.5mg of BAT5906
4.0mg of BAT5906Experimental16mg/0.2ml/piece; route of administration: intravitreal injection; dose: 4.0mg/eye/time, 50μl; duration of administration: once every 4 weeks, 3 times after continuous administration , The effectiveness was observed to the 48th week.
Receives: Drug: 4mg of BAT5906

What is being measured

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

  1. Dose-response relationships

    Trend chart of changes in the best corrected visual acuity from baseline

    Measured: week 24

Secondary outcomes (4)

  1. BCVA

    the best corrected visual acuity

    Measured: week 12 ，week 48

  2. CRT

    The mean thickness of the central retina with a diameter of 1mm, centered on the fixed point of view

    Measured: week 12 ，week 24，week 48

  3. 95% confidence interval

    The estimated interval of the population parameters constructed from the sample statistics

    Measured: week 12 ，week 24，week 48

  4. Average times of administration

    The times of administration of each dose group were summarized

    Measured: week 24，week 48

Timeline

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

  1. First posted2 Dec 2021
  2. Study start26 Aug 2020
  3. Primary completion6 Sep 2022
  4. Study completion6 Sep 2022

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05141994
Sponsor's protocol ID
BAT5906-002-CR
Status last verified
Apr 2024
First submitted
22 Jun 2020
Last updated
16 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 2.5mg of BAT5906 and 4mg of BAT5906 in people with Wet Age-related Macular Degeneration, run by Bio-Thera Solutions at 16 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 7 inclusion and 41 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 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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 phase mean?

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?

Dose-response relationships (time frame: week 24). 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 NCT05141994.

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 16 Apr 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in