Neovascular Age-Related Macular DegenerationPhase 2NCT06196840
Safety and Efficacy of LX102 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD) (VENUS)
A Phase 2 study testing LX102 subretinal injection and Aflibercept intravitreal injection in people with Neovascular Age-Related Macular Degeneration, run by Innostellar Biotherapeutics Co.,Ltd at 11 sites in China.
Trial summary
The goal of this study is to evaluate the overall safety and efficacy of LX102 gene therapy for nAMD. Read more about this study
- Who is it for?
- Ages 50 to 89 years
- Conditions the study is for
- Neovascular Age-Related Macular Degeneration
- What is being tested?
- LX102 subretinal injection and Aflibercept intravitreal injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 11 sitesChina
- Study dates
- 24 Jan 2024to Oct 2029
- Phase
- Phase 2
- 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 to 89 years
- 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, and ≤ 89.
- Diagnosis of active CNV secondary to neovascular AMD.
- BCVA ETDRS letters between 19 and 73.
- 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.
- Absence of RPE tear at Screening.
- 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 >8.0%.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites
Peking Union Medical College Hospital
Beijing
West China Hospital of Sichuan University
Chengdu
Guangzhou Aier Eye Hospital
Guangzhou
Zhongshan Ophthalmic Center of Sun Yat-Sen University
Guangzhou
Zhejiang University Eye Hospital
Hangzhou, Zhejiang
Anhui Provincial Hospital
Hefei, Anhui
Shanghai Eye and ENT Hospital
Shanghai
Shanghai General Hospital
Shanghai
Shanxi Eye Hospital
Taiyuan
Tianjin Medical University Eye Hospital
Tianjin
Xuzhou No.1 People's Hospital
Xuzhou
About this study
Official title: A Phase 2, Randomized Controlled, Open-Label Study to Establish the Safety and Efficacy of LX102 in Patients With Neovascular Age-related Macular Degeneration (nAMD) (VENUS)
The goal of this study is to evaluate the overall safety and efficacy of LX102 gene therapy for nAMD.
Read the detailed description
In this Phase 2, multi-center, randomized controlled study, subjects will be randomized to receive one of the two dose levels of LX102 (n=20 for each dose level), or aflibercept (n=10).
Safety, tolerability, and efficacy will be evaluated for a period of approximately 1 year from baseline.
- Being tested
- LX102 subretinal injection, Aflibercept intravitreal 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
Aflibercept intravitreal injectionBiological
Commercially available Active Comparator
| Study group | Role | What they receive |
|---|---|---|
| LX102 Dose 1 | Experimental | LX102 will be administered at the assigned dose level as a single dose subretinal injection on Day 0 Receives: Genetic: LX102 subretinal injection |
| LX102 Dose 2 | Experimental | LX102 will be administered at the assigned dose level as a single dose subretinal injection on Day 0 Receives: Genetic: LX102 subretinal injection |
| Control group | Active comparator | Aflibercept at a fixed regimen will be administered. Receives: Biological: Aflibercept intravitreal injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in Best Corrected Visual Acuity (BCVA)
BCVA measured by ETDRS
Measured: 36 weeks
Secondary outcomes (4)
Mean change from baseline in Best Corrected Visual Acuity (BCVA)
BCVA measured by ETDRS
Measured: 52 weeks
Mean change in Central Subfield Thickness (CST) from Baseline
CST measured by spectral domain optical coherence tomography (SD-OCT)
Measured: 36 weeks, 52 weeks
Durability of LX102 treatment
Mean time from LX102 administration to anti-VEGF rescue injection for the first time, percentage of participants requiring anti-VEGF rescue injection, and mean number of anti-VEGF rescue injections through 52 weeks following LX102 administration.
Measured: 52 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: 36 weeks, 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start24 Jan 2024
- Primary completion24 Jun 2025
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
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
- NCT06196840
- Sponsor's protocol ID
- INNOSTELLAR-LX102A01-2
- Status last verified
- Mar 2026
- First submitted
- 25 Dec 2023
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized Controlled, Open-Label Study to Establish the Safety and Efficacy of LX102 in Patients With Neovascular Age-related Macular Degeneration (nAMD) (VENUS)
- ClinicalTrials.gov ID
- NCT06196840
- Acronym / sponsor ID
- INNOSTELLAR-LX102A01-2
- Keywords
- Age-related macular degeneration, AMD, Neovascular AMD, Neovascular age-related macular degeneration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Innostellar Biotherapeutics Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 24 Jun 2025 (actual)
- Study completion
- Oct 2029 (estimated)
- First posted
- 9 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 overall safety and efficacy of LX102 gene therapy for nAMD.
Detailed description
In this Phase 2, multi-center, randomized controlled study, subjects will be randomized to receive one of the two dose levels of LX102 (n=20 for each dose level), or aflibercept (n=10).
Safety, tolerability, and efficacy will be evaluated for a period of approximately 1 year from baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LX102 Dose 1 | Experimental | Genetic: LX102 subretinal injectionLX102 will be administered at the assigned dose level as a single dose subretinal injection on Day 0 |
| LX102 Dose 2 | Experimental | Genetic: LX102 subretinal injectionLX102 will be administered at the assigned dose level as a single dose subretinal injection on Day 0 |
| Control group | Active comparator | Biological: Aflibercept intravitreal injectionAflibercept at a fixed regimen will be administered. |
Who may qualify
- Ages
- 50 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Willing to sign the informed consent, and willing to attend follow-up visits.
- Age ≥ 50, and ≤ 89.
- Diagnosis of active CNV secondary to neovascular AMD.
- BCVA ETDRS letters between 19 and 73.
- Demonstrated a meaningful response to anti-VEGF therapy.
Key exclusion criteria (6 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.
- Absence of RPE tear at Screening.
- 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.
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 |
| Aflibercept intravitreal injectionCommercially available Active Comparator | Biological | Control group |
Primary outcome
Mean change from baseline in Best Corrected Visual Acuity (BCVA)
Time frame: 36 weeks
BCVA measured by ETDRS
4 secondary outcomes
Mean change from baseline in Best Corrected Visual Acuity (BCVA)
Time frame: 52 weeks
Mean change in Central Subfield Thickness (CST) from Baseline
Time frame: 36 weeks, 52 weeks
Durability of LX102 treatment
Time frame: 52 weeks
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: 36 weeks, 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 6 Mar 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LX102 subretinal injection and Aflibercept intravitreal injection in people with Neovascular Age-Related Macular Degeneration, run by Innostellar Biotherapeutics Co.,Ltd at 11 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 5 inclusion and 6 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 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
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?
Mean change from baseline in Best Corrected Visual Acuity (BCVA) (time frame: 36 weeks). 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 6 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.