nAMDPhase 1NCT06737354
Safety and Efficacy Study of IVB103 Injection in Subjects With Neovascular (Wet) Agerelated Macular Degeneration (nAMD).
A Phase 1 study testing IVB103 Injection（Low dose）, IVB103 Injection（Intermediate dose） and IVB103 Injection（High dose） in people with nAMD, run by InnoVec Biotherapeutics Inc. at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the safety and efficacy of IVB103 injection in subjects with nAMD. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- nAMD
- What is being tested?
- IVB103 Injection（Low dose）, IVB103 Injection（Intermediate dose） and IVB103 Injection（High dose）
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 22 Apr 2025to 31 Dec 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects voluntarily participate and sign the informed consent form;
- Age≥ 50 years old, gender is not limited;
- Confirmed presence of active CNV secondary to nAMD in the macula of study eye;
- The total area of all types of lesions in the study eye < 30 mm2;
- The Best Corrected Visual Acuity (BCVA) detected by the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart in the study eye is 63~19 letters (including boundary values), which is equivalent to 20/63 to 20/400 of the Snellen Eye Chart;
- The BCVA detected by the ETDRS eye chart in the non-study eye is not less than 19 letters, which is equivalent to 20/400 of the Snellen Eye Chart;
- The study eye has received at least 2 episodes of intravitreal anti- VEGF therapy within 6 months prior to screening and has responded within two weeks of the lead-in period of anti-VEGF standard therapy (Aflibercept injection);
- At screening, the blood pregnancy test result of females of childbearing potential (e.g., females who have not undergone surgical sterilization or less than 1 year after menopause) is negative. Male and female subjects of childbearing potential agree to use effective contraception throughout the study and for at least 12 months after dosing.
Who cannot join
- Study Eye：
- Opacity of refractive media or inability to dilate pupils in the study eye that significantly interferes with visual acuity detection, anterior segment or fundus assessment;
- Presence of retinal hemorrhage, geographic atrophy, scarring or fibrosis, dense subfoveal hard exudate, retinal pigment epithelium (RPE) tear involving the fovea in the study eye;
- The study eye is combined with ocular diseases that affect central vision (e.g., diabetic retinopathy, retinal vein occlusion, vascular streaks, pathological myopia, retinal detachment, macular hole, epimacular membrane, toxoplasmosis, optic nerve disease, central serous choroidopathy, Inherited Retinal Diseases(IRDs), etc.);
- Active intraocular or periocular infection (such as blepharitis, conjunctivitis, keratitis, scleritis, etc.) in the study eye;
- Patients with glaucoma and ocular hypertension (intraocular pressure ≥ 25mmHg during the screening period) in the study eye;
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- Subjects with a history of intravitreal procedures other than anti- VEGF administration within the last six months (e.g., vitrectomy, macular translocation, trabecular meshwork removal, or other filtration surgery;
- History of laser or photodynamic therapy for nAMD;
- Presence of an ocular implant in the study eye (excluding intraocular lens, custom flex iris prosthesis); Either eye：
- History of uveitis in either eye; Systemic diseases and others：
- Those with diffuse intravascular coagulation and obvious bleeding tendency (such as hemoptysis, hematemesis, severe purpura, etc.) within 3 months before screening;
- History of myocardial infarction, unstable angina, coronary revascularization, cerebrovascular accident (including TIA), history of other thromboembolic diseases (such as thromboembolic angiitis, pulmonary embolism, deep vein thrombosis, portal vein thrombosis, etc.), New York Heart Association (NYHA) grade ≥ II cardiac insufficiency, severe unstable ventricular arrhythmia, within 6 months prior to screening;
- Have contraindications to transient immunosuppression of systemic prophylaxis (including but not limited to tuberculosis, osteoporosis, peptic ulcer, severe affective disorder) or immunocompromised;
- Patients with systemic immune diseases (including systemic lupus erythematosus, ankylosing spondylitis, rheumatoid arthritis, etc.);
- Diabetic patients with any of the following conditions: Known macrovascular complications; Glycosylated hemoglobin at screening（HbA1c）>7.5%; Those who have received more than two oral hypoglycemic drugs or received insulin or GLP-1 receptor agonists therapies;
- Hypertensive patients with poor blood pressure control (defined as:
- systolic blood pressure ≥ 160 mmHg or diastolic blood pressure
- ≥100 mmHg when the subject is seated after receiving antihypertensive medication);
- Any uncontrollable clinical illness (such as severe psychiatric, respiratory and other systemic diseases and history of malignant tumors);
- Patients with abnormal liver and kidney function: alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≥ 2 times the upper limit of normal; Total bilirubin ≥ 1.5 times the upper limit of normal, creatinine and urea/urea nitrogen ≥ 1.5 times the upper limit of normal;
- Patients with abnormal coagulation function: prothrombin time (PT) > upper limit of normal value of 3 seconds or activated partial thromboplasting time (APTT) > upper limit of normal value of 10 seconds; Haemoglobin (HGb) < 10 g/dL;
- Those who are positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, treponema pallidum antibody and human immunodeficiency virus (HIV) antibody;
- AAV neutralizing antibody titer >1:1000;
- Those who are known to be allergic to the therapeutic drugs or diagnostic drugs used in the study protocol, including the investigational products, fluorescein sodium, indocyanine green, etc.;
- Those who have used anticoagulant or antiplatelet drugs within 14 days before dosing;
- Currently using or may need to use drugs that can cause crystal toxicity or retinal toxicity (such as deferrigin, chloroquine
- /hydroxychloroquine, tamoxifen, ethambutol, etc.);
- Those who have a history of surgical operation within 1 month before screening, and/or currently have unhealed wounds (wound degree> stage III), moderate to severe ulcers, and fractures;
- Patients with systemic infectious diseases requiring systemic treatment (oral, intramuscular or intravenous) at the time of screening;
- Those who have received any AAV gene therapy products in the past;
- Pregnant or lactating females;
- Those who have participated in any clinical trial of drugs (excluding vitamins and minerals) within 3 months before screening;
- Other those who need to be excluded in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610000
MeiXia Zhang, +8618980602236, meixiazhang@foxmail.com
About this study
Official title: An Exploratory Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of IVB103 Injection in Subjects With Neovascular (Wet) Agerelated Macular Degeneration (nAMD).
The goal of this clinical trial is to evaluate the safety and efficacy of IVB103 injection in subjects with nAMD.
Read the detailed description
This is an open-label, non-randomized, multi-center dose escalation study. One eye of each participant will receive a single IVB103 injection by intravitreal injection. Participants will be followed for 52 weeks after which they will continue to be followed for up to 5 years after enrollment.
- Conditions
- nAMD
- Being tested
- IVB103 Injection（Low dose）, IVB103 Injection（Intermediate dose）, IVB103 Injection（High dose）
- Keywords
- nAMD, Retinal Disease
- Medical subject headings
- Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVB103 Injection（Low dose）Genetic
Single intravitreal injection
IVB103 Injection（Intermediate dose）Genetic
Single intravitreal injection
IVB103 Injection（High dose）Genetic
Single intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| IVB103 Treatment Arm（Low dose） | Experimental | Intraocular injection of a single low dose of IVB103 Receives: Genetic: IVB103 Injection（Low dose） |
| IVB103 Treatment Arm（Intermediate dose） | Experimental | Intraocular injection of a single intermediate dose of IVB103 Receives: Genetic: IVB103 Injection（Intermediate dose） |
| IVB103 Treatment Arm（High dose） | Experimental | Intraocular injection of a single high dose of IVB103 Receives: Genetic: IVB103 Injection（High dose） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of DLTs
Number and proportion of dose limited toxicity（DLTs）
Measured: 4 weeks
Incidence of AEs
Number and severity of overall and ocular Adverse Events (AEs)
Measured: 52 weeks
Incidence of SAEs
Number and severity of overall and ocular Serious Adverse Events (SAEs)
Measured: 52 weeks
Secondary outcomes (4)
Visual function
Change from baseline in BCVA(Best Corrected Visual Acuity)(ETDRS)
Measured: 52 weeks
OCT imaging
Change from baseline in CST(Central Retinal Thickness)(OCT)
Measured: 52 weeks
the number of anti-VEGF remedy therapy
the number of anti-VEGF remedy therapy within 52 weeks after dosing;
Measured: 52 weeks
mean annualized anti-VEGF injection rate
change in mean annualized anti-VEGF injection rate
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start22 Apr 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for nAMDStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InnoVec Biotherapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NeoVec Biotherapeutics Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737354
- Sponsor's protocol ID
- IVB103-C101
- Status last verified
- Nov 2026
- First submitted
- 11 Dec 2024
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of IVB103 Injection in Subjects With Neovascular (Wet) Agerelated Macular Degeneration (nAMD).
- ClinicalTrials.gov ID
- NCT06737354
- Acronym / sponsor ID
- IVB103-C101
- Conditions
- nAMD
- Keywords
- nAMD, Retinal Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- InnoVec Biotherapeutics Inc.Industry (pharma, biotech, devices)
- Collaborators
- NeoVec Biotherapeutics Inc.
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 17 Dec 2024 (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.
The goal of this clinical trial is to evaluate the safety and efficacy of IVB103 injection in subjects with nAMD.
Detailed description
This is an open-label, non-randomized, multi-center dose escalation study. One eye of each participant will receive a single IVB103 injection by intravitreal injection. Participants will be followed for 52 weeks after which they will continue to be followed for up to 5 years after enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IVB103 Treatment Arm（Low dose） | Experimental | Genetic: IVB103 Injection（Low dose）Intraocular injection of a single low dose of IVB103 |
| IVB103 Treatment Arm（Intermediate dose） | Experimental | Genetic: IVB103 Injection（Intermediate dose）Intraocular injection of a single intermediate dose of IVB103 |
| IVB103 Treatment Arm（High dose） | Experimental | Genetic: IVB103 Injection（High dose）Intraocular injection of a single high dose of IVB103 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects voluntarily participate and sign the informed consent form;
- Age≥ 50 years old, gender is not limited;
- Confirmed presence of active CNV secondary to nAMD in the macula of study eye;
- The total area of all types of lesions in the study eye < 30 mm2;
- The Best Corrected Visual Acuity (BCVA) detected by the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart in the study eye is 63~19 letters (including boundary values), which is equivalent to 20/63 to 20/400 of the Snellen Eye Chart;
Key exclusion criteria (33 listed)
- Study Eye：
- Opacity of refractive media or inability to dilate pupils in the study eye that significantly interferes with visual acuity detection, anterior segment or fundus assessment;
- Presence of retinal hemorrhage, geographic atrophy, scarring or fibrosis, dense subfoveal hard exudate, retinal pigment epithelium (RPE) tear involving the fovea in the study eye;
- The study eye is combined with ocular diseases that affect central vision (e.g., diabetic retinopathy, retinal vein occlusion, vascular streaks, pathological myopia, retinal detachment, macular hole, epimacular membrane, toxoplasmosis, optic nerve disease, central serous choroidopathy, Inherited Retinal Diseases(IRDs), etc.);
- Active intraocular or periocular infection (such as blepharitis, conjunctivitis, keratitis, scleritis, etc.) 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 |
|---|---|---|
| IVB103 Injection（Low dose）Single intravitreal injection | Genetic | IVB103 Treatment Arm（Low dose） |
| IVB103 Injection（Intermediate dose）Single intravitreal injection | Genetic | IVB103 Treatment Arm（Intermediate dose） |
| IVB103 Injection（High dose）Single intravitreal injection | Genetic | IVB103 Treatment Arm（High dose） |
Primary outcome
Incidence of DLTs
Time frame: 4 weeks
Number and proportion of dose limited toxicity（DLTs）
Incidence of AEs
Time frame: 52 weeks
Number and severity of overall and ocular Adverse Events (AEs)
Incidence of SAEs
Time frame: 52 weeks
Number and severity of overall and ocular Serious Adverse Events (SAEs)
4 secondary outcomes
Visual function
Time frame: 52 weeks
OCT imaging
Time frame: 52 weeks
the number of anti-VEGF remedy therapy
Time frame: 52 weeks
mean annualized anti-VEGF injection rate
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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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.
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 IVB103 Injection（Low dose）, IVB103 Injection（Intermediate dose） and IVB103 Injection（High dose） in people with nAMD, run by InnoVec Biotherapeutics Inc. 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 8 inclusion and 33 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: looking for participants now, as of the sponsor's last update on 4 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cheng Wang (+8613611238062, clinicaltrial@innovecbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of DLTs (time frame: 4 weeks). The study lists 3 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 4 Nov 2026.