Age-related Macular DegenerationPhase 1NCT04151212
A Phase I Clinical Trial of BAT5906 Injection in Patients With Wet Age-related Macular Degeneration
A Phase 1 study testing BAT5906 injection in people with Age-related Macular Degeneration, run by Bio-Thera Solutions at 1 site in China.
Trial summary
A Phase I Clinical Trial for BAT5906(single-dose;for injection) on Safety and Pharmacokinetics for Patients with Age-related macular degeneration. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Age-related Macular Degeneration
- What is being tested?
- BAT5906 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2018to 30 Apr 2021
- Phase
- Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 50-80 years old .
- Signing the informed consent form and able and willing to comply with all treatment and follow-up study procedures.
- The study eye must meet all the following inclusion criteria: To be diagnosed as wet age related macular degeneration, and there are still active lesions currently;Total lesion size of ≤30mm2( 12 disc areas);Best corrected visual acuity ≤70 Early Treatment of Diabetic Retinopathy ;Study letters (≤20/40) in the study eye.
- Best corrected visual acuity ≥34 Early Treatment of Diabetic Retinopathy Study letters (≥20/200) . in the non-study eye.
Who cannot join
- There are atrophy of the ground pattern involving the fovea, scar or fibrosis, macular anterior membrane, rigid exudation under dense fovea, RPE tear in the study eye.
- Retinal hemorrhage ≥4 disc area in the study eye.
- Dioptric media turbid or the pupil cannot be dilated were significant interference with the detection of vision, the evaluation of the anterior segment and fundus in the study eye.
- Evidence of ocular disease other than exudative AMD in the study eye that may confound the outcome of the study (e.g.,Retinal vein occlusion, uveitis, vascular striatum, pathological myopia, retinal detachment, macular hole, toxoplasmosis, optic nerve disease etc).
- History of vitrectomy surgery\macular transposition\glaucoma filtration in the study eye.
- Photodynamic therapy(PDT), in macular area laser photocoagulation therapy, transpermary hyperthermia(TTT), and other operations for AMD within 3 months prior to screening visit in the study eye.
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- History of extraocula surgeryr within 1 months or cataract surgery within 3 months prior to screening visit in the study eye.
- Aphakia(exclusive of intraocular lens) or rupture of posterior capsule( within1 months prior to the YAG laser retrovesiculotomy (after the artificial crystal), was excluded) in the study eye.
- APD in the study eye or pseudocyst stripping syndrome in either eye.
- Intravitrea or Systemicl anti-VEGF injection (ranibizumab, aflibercept, bevacizumab or Conbercept etc) in either eye within 3 months prior to screening visit.
- Under the conjunctiva,intravitreal or periocular corticosteroid, within 3 months prior to screening visit in either eye.
- vitreous hemorrhage within 3 months prior to screening Visit in either eye.
- Ocular or periocular infection in either eye.
- History of glaucoma in either eye.
- Visudyne (verteporfin) photodynamic therapy within 1 months prior to screening Visit in non-study eye.
- Currently in use or may be required to use systemic drugs that cause crystal toxicity or retinal toxicity, such as Deferoxamine, chloroquine/ hydroxychloroquine, phenothiazine and ethambutol or tamoxifen etc.
- Have an allergic reaction or history of allergic reactions to fluorescein sodium and indocyanine green, an allergic history to therapeutic or diagnostic protein products, an allergic reaction to more than two drugs or non-drug factors, or allergic reactions to any monoclonal antibody.
- Patients with diabetic retinopathy or the diabetic patient who have glycosylated? hemoglobin>10%.
- Patients who have undergone any surgical operation within 1 month prior screening; or/and there are unhealed wounds, ulcers, fractures etc.
- Systemic infectious diseases with clinical significance requiring oral, intramuscular or Patients withintravenous administration.
- Myocardial infarction, cerebral infarction and angina pectoris within 6 months prior to screening visit.
- Patients with active disseminated intravascular coagulation and obvious bleeding tendency were screened within 3 months before the screening, or they were treated with anticoagulant and antiplatelet therapy other than aspirin/NSAIDs within 14 days before the screening.
- Patients with Systemic immune disease ,including but not limited to:
- hyperthyroidism, hypothyroidism,vitiligo, dry-syndrome, ankylosing spondylitis, systemic nephritis, human immunodeficiency virus (HIV).
- Blood pressure control is not ideal or pre-hypertension.
- Any uncontrollable clinical problems (Serious mental, nervous, cardiovascular and respiratory diseases and malignant tumors).
- Abnormal liver and kidney function.
- Blood coagulation is abnormal.
- Patients with AIDS, syphilis or active hepatitis.
- Women are not using effective contraception or in pregnancy,lactation.
- Clinical trials of any trial medication or any other experimental or experimental therapy may be performed within 3 months prior to screening.
- Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing
About this study
Official title: A Phase I Clinical Trial for BAT5906(Single-dose;for Injection) on Safety and Pharmacokinetics for Patients With Age-related Macular Degeneration
A Phase I Clinical Trial for BAT5906(single-dose;for injection) on Safety and Pharmacokinetics for Patients with Age-related macular degeneration.
Read the detailed description
The primary objective: To evaluate the safety and Pharmacokinetics of BAT5906 (single-dose Ophthalmic Intracireal Iinjection) in patients wAMD , when the injection dosage escalates.
The Secondary objective: To evaluate the immunogenicity profile of BAT5906; To evaluate the pharmacodynamics and therapeutic efficacy profile of BAT5906.
- Conditions
- Age-related Macular Degeneration
- Being tested
- BAT5906 injection
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAT5906 injectionDrug
Also called No Other Intervention Names
Signal dose escalation starting from 0.3mg. Route of administration: intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| BAT5906 injection | Experimental | Single dose escalation starting from 0.3mg. Route of administration: intravitreal injection. Receives: Drug: BAT5906 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity(DLT)
Safety and tolerability endpoint
Measured: 2 weeks
Maximum tolerated dosed(MTD)
Safety and tolerability endpoint
Measured: 0-70days
Area under the curve(AUC0-t, AUC0-inf)
Pharmacokinetic endpoint Pharmacokinetic endpoint
Measured: 0-70days
Maximum serum drug concentration(Cmax)
Pharmacokinetic endpoint Pharmacokinetic endpoint
Measured: 0-70days
Half-life period(t1/2)
Pharmacokinetic endpoint
Measured: 0-70days
Maximum serum drug time(Tmax)
Pharmacokinetic endpoint
Measured: 0-70days
Plasma clearance(CL)
Pharmacokinetic endpoint
Measured: 0-70days
Secondary outcomes (4)
Anti-drug antibodies(ADA)
Immunogenic endpoint
Measured: 0-70days
Best correct vision(BCVA)
Effective endpoint
Measured: 0-70days
Central Retinal thickness(CRT)
Effective endpoint
Measured: 0-70days
VEGF concentration
Pharmacodynamics endpoint
Measured: 0-70days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start30 Oct 2018
- Primary completion28 Feb 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio-Thera Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Youxin Chen, Principal investigator, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04151212
- Sponsor's protocol ID
- BAT5906-001-CR
- Status last verified
- Oct 2019
- First submitted
- 4 Nov 2019
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial for BAT5906(Single-dose;for Injection) on Safety and Pharmacokinetics for Patients With Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT04151212
- Acronym / sponsor ID
- BAT5906-001-CR
- Conditions
- Age-related Macular Degeneration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Bio-Thera SolutionsIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 5 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase I Clinical Trial for BAT5906(single-dose;for injection) on Safety and Pharmacokinetics for Patients with Age-related macular degeneration.
Detailed description
The primary objective: To evaluate the safety and Pharmacokinetics of BAT5906 (single-dose Ophthalmic Intracireal Iinjection) in patients wAMD , when the injection dosage escalates.
The Secondary objective: To evaluate the immunogenicity profile of BAT5906; To evaluate the pharmacodynamics and therapeutic efficacy profile of BAT5906.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BAT5906 injection | Experimental | Drug: BAT5906 injectionSingle dose escalation starting from 0.3mg. Route of administration: intravitreal injection. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female aged 50-80 years old .
- Signing the informed consent form and able and willing to comply with all treatment and follow-up study procedures.
- The study eye must meet all the following inclusion criteria: To be diagnosed as wet age related macular degeneration, and there are still active lesions currently;Total lesion size of ≤30mm2( 12 disc areas);Best corrected visual acuity ≤70 Early Treatment of Diabetic Retinopathy ;Study letters (≤20/40) in the study eye.
- Best corrected visual acuity ≥34 Early Treatment of Diabetic Retinopathy Study letters (≥20/200) . in the non-study eye.
Key exclusion criteria (32 listed)
- There are atrophy of the ground pattern involving the fovea, scar or fibrosis, macular anterior membrane, rigid exudation under dense fovea, RPE tear in the study eye.
- Retinal hemorrhage ≥4 disc area in the study eye.
- Dioptric media turbid or the pupil cannot be dilated were significant interference with the detection of vision, the evaluation of the anterior segment and fundus in the study eye.
- Evidence of ocular disease other than exudative AMD in the study eye that may confound the outcome of the study (e.g.,Retinal vein occlusion, uveitis, vascular striatum, pathological myopia, retinal detachment, macular hole, toxoplasmosis, optic nerve disease etc).
- History of vitrectomy surgery\macular transposition\glaucoma filtration in the study eye.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAT5906 injectionAlso: No Other Intervention NamesSignal dose escalation starting from 0.3mg. Route of administration: intravitreal injection | Drug | BAT5906 injection |
Primary outcome
Dose-limiting toxicity(DLT)
Time frame: 2 weeks
Safety and tolerability endpoint
Maximum tolerated dosed(MTD)
Time frame: 0-70days
Safety and tolerability endpoint
Area under the curve(AUC0-t, AUC0-inf)
Time frame: 0-70days
Pharmacokinetic endpoint Pharmacokinetic endpoint
Maximum serum drug concentration(Cmax)
Time frame: 0-70days
Pharmacokinetic endpoint Pharmacokinetic endpoint
Half-life period(t1/2)
Time frame: 0-70days
Pharmacokinetic endpoint
Maximum serum drug time(Tmax)
Time frame: 0-70days
Pharmacokinetic endpoint
Plasma clearance(CL)
Time frame: 0-70days
Pharmacokinetic endpoint
4 secondary outcomes
Anti-drug antibodies(ADA)
Time frame: 0-70days
Best correct vision(BCVA)
Time frame: 0-70days
Central Retinal thickness(CRT)
Time frame: 0-70days
VEGF concentration
Time frame: 0-70days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Youxin Chen principal investigator
Peking Union Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAT5906 injection in people with Age-related Macular Degeneration, run by Bio-Thera Solutions at 1 site 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 4 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 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
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-limiting toxicity(DLT) (time frame: 2 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2026.