Neovascular Age-Related Macular DegenerationPhase 1NCT06198413
LX102 in Patients With Neovascular Age-Related Macular Degeneration (nAMD)
A Phase 1 study testing LX102 subretinal injection in people with Neovascular Age-Related Macular Degeneration, run by Innostellar Biotherapeutics Co.,Ltd at 3 sites in China.
Trial summary
The goal of this study is to evaluate the safety and efficacy of LX102 gene therapy for nAMD. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age-Related Macular Degeneration
- What is being tested?
- LX102 subretinal injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesChina
- Study dates
- 27 Feb 2023to Jan 2029
- 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
- Willing to sign the informed consent, and willing to attend follow-up visits.
- Age ≥ 50
- Diagnosis of active CNV secondary to neovascular AMD
- BCVA ETDRS letters between 5 and 63
- Subjects must have received a minimum of 2 injections within 6 months prior to screening
- Demonstrated a meaningful response to anti-VEGF therapy
Who cannot join
- CNV or macular edema in the study eye secondary to diseases other than nAMD
- Retinal detachment, uveitis, uncontrolled glaucoma in the study eye, or any condition preventing visual acuity improvement
- Acute coronary syndrome, myocardial infarction or coronary artery revascularization, CVA, TIA in the last 6 months
- Uncontrolled hypertension defined as average SBP ≥160 mmHg or an average DBP ≥100 mmHg
- Uncontrolled diabetes defined as HbA1c >7.5%
Trial locations and contacts
3 sites in 1 country.
China3 sites
Zhejiang University Eye Hospital
Hangzhou, Zhejiang
Anhui Provincial Hospital
Hefei, Anhui
Shanghai General Hospital
Shanghai
About this study
Official title: A Dose-Escalation Study of LX102 Gene Therapy for Neovascular Age-Related Macular Degeneration (nAMD)
The goal of this study is to evaluate the safety and efficacy of LX102 gene therapy for nAMD.
Read the detailed description
This study will enroll subjects aged ≥ 50 years old to receive a single unilateral subretinal injection of LX102 to evaluate its safety and efficacy.
- Being tested
- LX102 subretinal injection
- Keywords
- Age-related macular degeneration, AMD, Neovascular AMD, Neovascular age-related macular degeneration
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LX102 subretinal injectionGenetic
LX102: AAV-based gene therapy comprised of codon-optimized sequence encoding VEGF-trap
| Study group | Role | What they receive |
|---|---|---|
| LX102 Dose 1 | Experimental | Low dose of LX102 Receives: Genetic: LX102 subretinal injection |
| LX102 Dose 2 | Experimental | Mid dose of LX102 Receives: Genetic: LX102 subretinal injection |
| LX102 Dose 3 | Experimental | High dose of LX102 Receives: Genetic: LX102 subretinal injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicity (DLT)
Incidence of dose-limiting toxicity (DLT) following LX102 subretinal injection at different doses
Measured: 4 weeks
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Incidence of ocular and systemic adverse events (AEs) and serious adverse events (SAEs) following LX102 subretinal injection
Measured: 52 weeks
Secondary outcomes (5)
Mean change in BCVA from Baseline
BCVA measured by ETDRS
Measured: 12 weeks, 36 weeks 52 weeks
Mean change in Central Subfield Thickness (CST) from Baseline
CST measured by spectral domain optical coherence tomography (SD-OCT)
Measured: 12 weeks, 36 weeks 52 weeks
Mean time from LX102 administration to anti-VEGF rescue injection for the first time
Measured: 52 weeks
Percentage of participants requiring anti-VEGF rescue injection
Measured: 52 weeks
Mean number of anti-VEGF rescue injections
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 posted10 Jan 2024
- Study start27 Feb 2023
- Primary completion26 Dec 2024
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neovascular 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innostellar Biotherapeutics Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198413
- Sponsor's protocol ID
- INNOSTELLAR-LX102A01-1
- Status last verified
- Jun 2025
- First submitted
- 25 Dec 2023
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li T, Feng J, Yang X, Yang S, Chen J, Wu Y, Li X, Ni Z, Liu Y, Song M, Huang P, Zheng K, Wang H, Xu X, Sun J, Wang F, Jia H, Sun X. Subretinal rAAV2-based VEGF-Trap gene therapy for neovascular age-related macular degeneration: Preclinical assessment and phase 1 trial results. Cell Rep Med. 2026 Jul 21;7(7):102869. doi: 10.1016/j.xcrm.2026.102869. Epub 2026 Jun 12.
PubMed 42285094
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-Escalation Study of LX102 Gene Therapy for Neovascular Age-Related Macular Degeneration (nAMD)
- ClinicalTrials.gov ID
- NCT06198413
- Acronym / sponsor ID
- INNOSTELLAR-LX102A01-1
- Keywords
- Age-related macular degeneration, AMD, Neovascular AMD, Neovascular age-related macular degeneration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Innostellar Biotherapeutics Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 26 Dec 2024 (actual)
- Study completion
- Jan 2029 (estimated)
- First posted
- 10 Jan 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 study is to evaluate the safety and efficacy of LX102 gene therapy for nAMD.
Detailed description
This study will enroll subjects aged ≥ 50 years old to receive a single unilateral subretinal injection of LX102 to evaluate its safety and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LX102 Dose 1 | Experimental | Genetic: LX102 subretinal injectionLow dose of LX102 |
| LX102 Dose 2 | Experimental | Genetic: LX102 subretinal injectionMid dose of LX102 |
| LX102 Dose 3 | Experimental | Genetic: LX102 subretinal injectionHigh dose of LX102 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Willing to sign the informed consent, and willing to attend follow-up visits.
- Age ≥ 50
- Diagnosis of active CNV secondary to neovascular AMD
- BCVA ETDRS letters between 5 and 63
- Subjects must have received a minimum of 2 injections within 6 months prior to screening
Key exclusion criteria (5 listed)
- CNV or macular edema in the study eye secondary to diseases other than nAMD
- Retinal detachment, uveitis, uncontrolled glaucoma in the study eye, or any condition preventing visual acuity improvement
- Acute coronary syndrome, myocardial infarction or coronary artery revascularization, CVA, TIA in the last 6 months
- Uncontrolled hypertension defined as average SBP ≥160 mmHg or an average DBP ≥100 mmHg
- Uncontrolled diabetes defined as HbA1c >7.5%
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 |
|---|---|---|
| LX102 subretinal injectionLX102: AAV-based gene therapy comprised of codon-optimized sequence encoding VEGF-trap | Genetic | LX102 Dose 1, LX102 Dose 2, LX102 Dose 3 |
Primary outcome
Incidence of dose-limiting toxicity (DLT)
Time frame: 4 weeks
Incidence of dose-limiting toxicity (DLT) following LX102 subretinal injection at different doses
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: 52 weeks
Incidence of ocular and systemic adverse events (AEs) and serious adverse events (SAEs) following LX102 subretinal injection
5 secondary outcomes
Mean change in BCVA from Baseline
Time frame: 12 weeks, 36 weeks 52 weeks
Mean change in Central Subfield Thickness (CST) from Baseline
Time frame: 12 weeks, 36 weeks 52 weeks
Mean time from LX102 administration to anti-VEGF rescue injection for the first time
Time frame: 52 weeks
Percentage of participants requiring anti-VEGF rescue injection
Time frame: 52 weeks
Mean number of anti-VEGF rescue injections
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 1 Jul 2025.
- Derived from this study: PubMed 42285094Li T, Feng J, Yang X, Yang S, Chen J, Wu Y, Li X, Ni Z, Liu Y, Song M, Huang P, Zheng K, Wang H, Xu X, Sun J, Wang F, Jia H, Sun X. Subretinal rAAV2-based VEGF-Trap gene therapy for neovascular age-related macular degeneration: Preclinical assessment and phase 1 trial results. Cell Rep Med. 2026 Jul 21;7(7):102869. doi: 10.1016/j.xcrm.2026.102869. Epub 2026 Jun 12.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LX102 subretinal injection in people with Neovascular Age-Related Macular Degeneration, run by Innostellar Biotherapeutics Co.,Ltd at 3 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 6 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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?
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?
Incidence of dose-limiting toxicity (DLT) (time frame: 4 weeks). The study lists 2 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 NCT06198413, which also lists 1 linked publication.
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 1 Jul 2025.