Neovascular Age-related Macular DegenerationNCT05831007
Safety and Efficacy Study of LX102-C01 Treatment of Neovascular Age-Related Macular Degeneration (nAMD)
A study testing LX102-C01 Injection in people with Neovascular Age-related Macular Degeneration, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The goal of this study is to evaluate the safety and efficacy of LX102-C01 treatment of nAMD. This study will enroll subjects aged ≥ 50 years old to receive a single unilateral intravitreal (IVT) injection of LX102-C01 to evaluate its safety and efficacy. 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-C01 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 6 Dec 2021to Jun 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Willing to sign the informed consent, and willing to attend follow-up visits.
- Age ≥ 50
- Diagnosis of active CNV secondary to neovascular AMD
- The study eye must have a best-corrected E-ETDRS visual acuity letter score of less than or equal to 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
1 site in 1 country.
China1 site
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200080
About this study
Official title: An Open Label Dose Escalation Clinical Trial to Evaluate the Safety and the Efficacy of LX102-C01 in Patients With Neovascular Age-Related Macular Degeneration (nAMD)
The goal of this study is to evaluate the safety and efficacy of LX102-C01 treatment of nAMD. This study will enroll subjects aged ≥ 50 years old to receive a single unilateral intravitreal (IVT) injection of LX102-C01 to evaluate its safety and efficacy.
- Being tested
- LX102-C01 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LX102-C01 InjectionGenetic
Qualified subjects will receive a single unilateral intravitreal injection of LX102-C01 at Day 0 in the trial.
| Study group | Role | What they receive |
|---|---|---|
| LX102-C01 Injection | Experimental | Potential doses:
3E10 vg, 0.06 mL/eye/dose
1E11 vg, 0.06 mL/eye/dose Receives: Genetic: LX102-C01 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs)
Incidence of adverse events (AEs) within 52 weeks of LX102-C01 intravitreal injection at different doses
Measured: 52 weeks
Incidence of serious adverse events (SAEs)
Incidence of serious adverse events (SAEs) within 52 weeks of LX102-C01 intravitreal injection at different doses
Measured: 52 weeks
Secondary outcomes (4)
Mean change in BCVA from Baseline
BCVA measured by ETDRS
Measured: 24 weeks, 52weeks
Mean change in Central Subfield Thickness (CST) from Baseline
To evaluate the effect of LX102-C01 on CST
Measured: 24 weeks, 52 weeks
Mean number of anti-VEGF injections over time
Mean number of anti-VEGF injections over time
Measured: 52 weeks
Change of quality of life scores (VFQ-25) from Baseline
Changes of VFQ-25 questionaire from Baseline to 52 weeks
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 posted26 Apr 2023
- Study start6 Dec 2021
- Primary completionJun 2023 (estimated)
- Study completionJun 2024 (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.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Innostellar Biotherapeutics
- Responsible party
- Principal investigator, Xiaodong Sun, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05831007
- Sponsor's protocol ID
- SHGH-LX102-C01
- Status last verified
- Apr 2023
- First submitted
- 14 Apr 2023
- Last updated
- 26 Apr 2023
- 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 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Dose Escalation Clinical Trial to Evaluate the Safety and the Efficacy of LX102-C01 in Patients With Neovascular Age-Related Macular Degeneration (nAMD)
- ClinicalTrials.gov ID
- NCT05831007
- Acronym / sponsor ID
- SHGH-LX102-C01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Innostellar Biotherapeutics
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 26 Apr 2023 (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-C01 treatment of nAMD. This study will enroll subjects aged ≥ 50 years old to receive a single unilateral intravitreal (IVT) injection of LX102-C01 to evaluate its safety and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LX102-C01 Injection | Experimental | Genetic: LX102-C01 InjectionPotential doses: 3E10 vg, 0.06 mL/eye/dose 1E11 vg, 0.06 mL/eye/dose |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Willing to sign the informed consent, and willing to attend follow-up visits.
- Age ≥ 50
- Diagnosis of active CNV secondary to neovascular AMD
- The study eye must have a best-corrected E-ETDRS visual acuity letter score of less than or equal to 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-C01 InjectionQualified subjects will receive a single unilateral intravitreal injection of LX102-C01 at Day 0 in the trial. | Genetic | LX102-C01 Injection |
Primary outcome
Incidence of adverse events (AEs)
Time frame: 52 weeks
Incidence of adverse events (AEs) within 52 weeks of LX102-C01 intravitreal injection at different doses
Incidence of serious adverse events (SAEs)
Time frame: 52 weeks
Incidence of serious adverse events (SAEs) within 52 weeks of LX102-C01 intravitreal injection at different doses
4 secondary outcomes
Mean change in BCVA from Baseline
Time frame: 24 weeks, 52weeks
Mean change in Central Subfield Thickness (CST) from Baseline
Time frame: 24 weeks, 52 weeks
Mean number of anti-VEGF injections over time
Time frame: 52 weeks
Change of quality of life scores (VFQ-25) from Baseline
Time frame: 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LX102-C01 Injection in people with Neovascular Age-related Macular Degeneration, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine 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 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: status not confirmed, as of the sponsor's last update on 26 Apr 2023. 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.
Are results available for this study?
Results are not available in the source record.
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 adverse events (AEs) (time frame: 52 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?
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 26 Apr 2023.