To Evaluate the Safety and Tolerability of Intravitreal Injection of LX109 in Patients With nAMDNCT06022744

An Exploratory Clinical Trial Evaluating LX109 Gene Therapy in Patients With nAMD

A study testing LX109 in people with To Evaluate the Safety and Tolerability of Intravitreal Injection of LX109 in Patients With nAMD, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial summary

To evaluate the safety and tolerability of intravitreal injection of LX109 in patients with nAMD. Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: To Evaluate the Safety and Tolerability of Intravitreal Injection of LX109 in Patients With nAMD
What is being tested?: LX109
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: No sites listed yet
Study dates: 1 Sep 2023to 30 Sep 2027
Phase: Interventional
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

1) Informed consent must be signed before all assessments; 2) Male or female patients ≥50 years of age; 3) To investigate the presence of active CNV secondary to nAMD (occult or micromenorrhea) in the eye 4) When studying the baseline of the eye, use the ETDRS eye chart to test the BCVA of 19 to 73 letters (approximately equivalent to decimal notation) Recorded visual acuity 0.05-0.5); 5) Study eyes received at least 2 anti-VEGF treatments within 6 months. Note: For all subjects, only one eye was used as the "study eye" (i.e. the study eye receiving treatment). If both eyes of the subject meet the inclusion criteria, the eye with poor baseline vision will be selected as the study eye, or the eye with better vision may be selected for medical reasons or ethical requirements.

Who cannot join

1. In the investigator's judgment, concomitant eye diseases of the study eye at screening or baseline may cause subjects to fail to respond to study therapy or confuse the interpretation of study findings. For example, diabetic retinopathy, retinal vein obstruction, retinal retinal detachment, macular hiatus (stage 3 or 4), uveitis, vitreous macular traction affecting central vision, macular anterior membrane involving macular fovea or damaging macular structure, equivalent spherical lens ≤-8.00D of the study eye, etc.
2. To investigate the presence of subretinal hyperreflective substance (SHRM) involving the fovea except CNV lesions; 3. Central serous chorioretinopathy (CSC) was confirmed in the study eyes at any time; 4. Study retinal detachment in the eye at any time; 5. Non-study eye BCV A less than decimal recorded visual acuity 0.05(<19 ETDRS letters); 6. The presence of uncontrolled glaucoma (defined as intraocular pressure ≥25mmHg after standard treatment) in the study eye; 7. Active intraocular or periocular inflammation or infection in the study eye or non-study eye; 8. To investigate the presence of CNV or macular edema secondary to causes other than AMD; 9. In the study, the refractive medium of the eye is seriously cloudy or the pupil cannot be sufficiently dilated, affecting BCVA or causing insufficient acquisition Clear eye imaging data, such as OCT, FFA, and fundus photography, affect researchers' observation of safety and efficacy.
Eye Treatment： 10. Internal eye surgery, such as vitrectomy, cataract phacoemulsification, trabeculectomy, or other filtering surgery, was performed within 3 months prior to baseline screening or study eye screening; 11. Study eyes screened or treated with intravitreal drug injections or drug-containing intraocular implants other than anti-VEGF drugs, such as intraocular corticosteroids, within 6 months prior to baseline; 12. Research eye or systemic have received gene therapy; 13. Study eyes screened or treated with macular laser photocoagulation or photodynamic therapy (PDT) or full vision membrane laser photocoagulation within 3 months prior to baseline; 14. Study eyes were screened or underwent YAG laser posterior capsulectomy or laser trabeculectomy or laser periiridectomy within 1 month prior to baseline

About this study

Official title: An Exploratory Clinical Trial Evaluating LX109 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD)

To evaluate the safety and tolerability of intravitreal injection of LX109 in patients with nAMD.

Read the detailed description

In this study, 9 to 12 participants were enrolled in an open monocular, single dose escalation study design. Two dose groups were set up: low dose group (7×109 VG/ eye, 0.05ml) and high dose group (3.5×1010 VG/ eye, 0.05ml). Among them, 3 to 6 subjects were enrolled in low-dose group and 6 subjects were enrolled in high-dose group.

Conditions: To Evaluate the Safety and Tolerability of Intravitreal Injection of LX109 in Patients With nAMD
Being tested: LX109

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LX109Drug
LX109 gene injection Specification: 0.2ml/bottle, 1.4×1012VG/ml Administration route: intravitreal injection, injection volume 0.05ml/eye

Study groups in NCT06022744
Study group	Role	What they receive
LX109	Experimental	Not described Receives: Drug: LX109

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse Event
Measured: 4 weeks

Secondary outcomes (5)

Change of mean BCVA score on the ETDRS visual acuity scale from baseline.
Changes of BCVA scores on the ETDRS visual acuity chart of the study eye from baseline at 4, 24 and 52 weeks after treatment with LX109.
Measured: 4 weeks、24 weeks、52 weeks
Changes in mean eye CST from baseline at 4, 24 and 52 weeks after LX109 treatment were studied.
Measured: 4 weeks、24 weeks、52 weeks
The time after LX109 treatment to the first salvage treatment.
Measured: 52 weeks
Proportion of subjects receiving salvage treatment in the study eye at 24 weeks and 52 weeks after treatment with LX109.
Measured: 24 weeks、52 weeks
The number of times the eye received salvage treatment at 24 weeks and 52 weeks after treatment with LX109 was studied.
Measured: 24 weeks、52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 202330 Sep 2027

First posted5 Sep 2023
Study start1 Sep 2023 (estimated)
Primary completion30 Sep 2025 (estimated)
Study completion30 Sep 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for To Evaluate the Safety and Tolerability of Intravitreal Injection of LX109 in Patients With nAMDStudies 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: 12 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06022744
Sponsor's protocol ID: SHGH-LX109
Status last verified: Sep 2023
First submitted: 28 Aug 2023
Last updated: 5 Sep 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Wong WL, Su X, Li X, Cheung CM, Klein R, Cheng CY, Wong TY. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health. 2014 Feb;2(2):e106-16. doi: 10.1016/S2214-109X(13)70145-1. Epub 2014 Jan 3.
PubMed 25104651
Yang K, Liang YB, Gao LQ, Peng Y, Shen R, Duan XR, Friedman DS, Sun LP, Mitchell P, Wang NL, Wong TY, Wang JJ. Prevalence of age-related macular degeneration in a rural Chinese population: the Handan Eye Study. Ophthalmology. 2011 Jul;118(7):1395-401. doi: 10.1016/j.ophtha.2010.12.030. Epub 2011 Mar 27.
PubMed 21444116
Ye H, Zhang Q, Liu X, Cai X, Yu W, Yu S, Wang T, Lu W, Li X, Jin H, Hu Y, Kang X, Zhao P. Prevalence of age-related macular degeneration in an elderly urban chinese population in China: the Jiangning Eye Study. Invest Ophthalmol Vis Sci. 2014 Sep 4;55(10):6374-80. doi: 10.1167/iovs.14-14899.
PubMed 25190650
van Lookeren Campagne M, LeCouter J, Yaspan BL, Ye W. Mechanisms of age-related macular degeneration and therapeutic opportunities. J Pathol. 2014 Jan;232(2):151-64. doi: 10.1002/path.4266.
PubMed 24105633
Mitchell P, Liew G, Gopinath B, Wong TY. Age-related macular degeneration. Lancet. 2018 Sep 29;392(10153):1147-1159. doi: 10.1016/S0140-6736(18)31550-2.
PubMed 30303083
Khandhadia S, Cherry J, Lotery AJ. Age-related macular degeneration. Adv Exp Med Biol. 2012;724:15-36. doi: 10.1007/978-1-4614-0653-2_2.
PubMed 22411231
Fleckenstein M, Keenan TDL, Guymer RH, Chakravarthy U, Schmitz-Valckenberg S, Klaver CC, Wong WT, Chew EY. Age-related macular degeneration. Nat Rev Dis Primers. 2021 May 6;7(1):31. doi: 10.1038/s41572-021-00265-2.
PubMed 33958600
Holz FG, Tadayoni R, Beatty S, Berger A, Cereda MG, Cortez R, Hoyng CB, Hykin P, Staurenghi G, Heldner S, Bogumil T, Heah T, Sivaprasad S. Multi-country real-life experience of anti-vascular endothelial growth factor therapy for wet age-related macular degeneration. Br J Ophthalmol. 2015 Feb;99(2):220-6. doi: 10.1136/bjophthalmol-2014-305327. Epub 2014 Sep 5.
PubMed 25193672
Cabral T, Lima LH, Mello LGM, Polido J, Correa EP, Oshima A, Duong J, Serracarbassa P, Regatieri CV, Mahajan VB, Belfort R Jr. Bevacizumab Injection in Patients with Neovascular Age-Related Macular Degeneration Increases Angiogenic Biomarkers. Ophthalmol Retina. 2018 Jan;2(1):31-37. doi: 10.1016/j.oret.2017.04.004.
PubMed 29376143

Study at a glance

From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Exploratory Clinical Trial Evaluating LX109 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD)
ClinicalTrials.gov ID: NCT06022744
Acronym / sponsor ID: SHGH-LX109
Conditions: To Evaluate the Safety and Tolerability of Intravitreal Injection of LX109 in Patients With nAMD
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 12 participants (estimated)
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
Study start: 1 Sep 2023 (estimated)
Primary completion: 30 Sep 2025 (estimated)
Study completion: 30 Sep 2027 (estimated)
First posted: 5 Sep 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.

To evaluate the safety and tolerability of intravitreal injection of LX109 in patients with nAMD.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
LX109	Experimental	Drug: LX109

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

1) Informed consent must be signed before all assessments; 2) Male or female patients ≥50 years of age; 3) To investigate the presence of active CNV secondary to nAMD (occult or micromenorrhea) in the eye 4) When studying the baseline of the eye, use the ETDRS eye chart to test the BCVA of 19 to 73 letters (approximately equivalent to decimal notation) Recorded visual acuity 0.05-0.5); 5) Study eyes received at least 2 anti-VEGF treatments within 6 months. Note: For all subjects, only one eye was used as the "study eye" (i.e. the study eye receiving treatment). If both eyes of the subject meet the inclusion criteria, the eye with poor baseline vision will be selected as the study eye, or the eye with better vision may be selected for medical reasons or ethical requirements.

Key exclusion criteria (3 listed)

1. In the investigator's judgment, concomitant eye diseases of the study eye at screening or baseline may cause subjects to fail to respond to study therapy or confuse the interpretation of study findings. For example, diabetic retinopathy, retinal vein obstruction, retinal retinal detachment, macular hiatus (stage 3 or 4), uveitis, vitreous macular traction affecting central vision, macular anterior membrane involving macular fovea or damaging macular structure, equivalent spherical lens ≤-8.00D of the study eye, etc.
2. To investigate the presence of subretinal hyperreflective substance (SHRM) involving the fovea except CNV lesions; 3. Central serous chorioretinopathy (CSC) was confirmed in the study eyes at any time; 4. Study retinal detachment in the eye at any time; 5. Non-study eye BCV A less than decimal recorded visual acuity 0.05(<19 ETDRS letters); 6. The presence of uncontrolled glaucoma (defined as intraocular pressure ≥25mmHg after standard treatment) in the study eye; 7. Active intraocular or periocular inflammation or infection in the study eye or non-study eye; 8. To investigate the presence of CNV or macular edema secondary to causes other than AMD; 9. In the study, the refractive medium of the eye is seriously cloudy or the pupil cannot be sufficiently dilated, affecting BCVA or causing insufficient acquisition Clear eye imaging data, such as OCT, FFA, and fundus photography, affect researchers' observation of safety and efficacy.
Eye Treatment： 10. Internal eye surgery, such as vitrectomy, cataract phacoemulsification, trabeculectomy, or other filtering surgery, was performed within 3 months prior to baseline screening or study eye screening; 11. Study eyes screened or treated with intravitreal drug injections or drug-containing intraocular implants other than anti-VEGF drugs, such as intraocular corticosteroids, within 6 months prior to baseline; 12. Research eye or systemic have received gene therapy; 13. Study eyes screened or treated with macular laser photocoagulation or photodynamic therapy (PDT) or full vision membrane laser photocoagulation within 3 months prior to baseline; 14. Study eyes were screened or underwent YAG laser posterior capsulectomy or laser trabeculectomy or laser periiridectomy within 1 month prior to baseline

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
LX109LX109 gene injection Specification: 0.2ml/bottle, 1.4×1012VG/ml Administration route: intravitreal injection, injection volume 0.05ml/eye	Drug	LX109

Primary outcome

Adverse Event
Time frame: 4 weeks

5 secondary outcomes

Change of mean BCVA score on the ETDRS visual acuity scale from baseline.
Time frame: 4 weeks、24 weeks、52 weeks
Changes in mean eye CST from baseline at 4, 24 and 52 weeks after LX109 treatment were studied.
Time frame: 4 weeks、24 weeks、52 weeks
The time after LX109 treatment to the first salvage treatment.
Time frame: 52 weeks
Proportion of subjects receiving salvage treatment in the study eye at 24 weeks and 52 weeks after treatment with LX109.
Time frame: 24 weeks、52 weeks
The number of times the eye received salvage treatment at 24 weeks and 52 weeks after treatment with LX109 was studied.
Time frame: 24 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 5 Sep 2023.
Background: PubMed 25104651Wong WL, Su X, Li X, Cheung CM, Klein R, Cheng CY, Wong TY. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health. 2014 Feb;2(2):e106-16. doi: 10.1016/S2214-109X(13)70145-1. Epub 2014 Jan 3.
Background: PubMed 21444116Yang K, Liang YB, Gao LQ, Peng Y, Shen R, Duan XR, Friedman DS, Sun LP, Mitchell P, Wang NL, Wong TY, Wang JJ. Prevalence of age-related macular degeneration in a rural Chinese population: the Handan Eye Study. Ophthalmology. 2011 Jul;118(7):1395-401. doi: 10.1016/j.ophtha.2010.12.030. Epub 2011 Mar 27.
Background: PubMed 25190650Ye H, Zhang Q, Liu X, Cai X, Yu W, Yu S, Wang T, Lu W, Li X, Jin H, Hu Y, Kang X, Zhao P. Prevalence of age-related macular degeneration in an elderly urban chinese population in China: the Jiangning Eye Study. Invest Ophthalmol Vis Sci. 2014 Sep 4;55(10):6374-80. doi: 10.1167/iovs.14-14899.
Background: PubMed 24105633van Lookeren Campagne M, LeCouter J, Yaspan BL, Ye W. Mechanisms of age-related macular degeneration and therapeutic opportunities. J Pathol. 2014 Jan;232(2):151-64. doi: 10.1002/path.4266.
Background: PubMed 30303083Mitchell P, Liew G, Gopinath B, Wong TY. Age-related macular degeneration. Lancet. 2018 Sep 29;392(10153):1147-1159. doi: 10.1016/S0140-6736(18)31550-2.
Background: PubMed 22411231Khandhadia S, Cherry J, Lotery AJ. Age-related macular degeneration. Adv Exp Med Biol. 2012;724:15-36. doi: 10.1007/978-1-4614-0653-2_2.
Background: PubMed 33958600Fleckenstein M, Keenan TDL, Guymer RH, Chakravarthy U, Schmitz-Valckenberg S, Klaver CC, Wong WT, Chew EY. Age-related macular degeneration. Nat Rev Dis Primers. 2021 May 6;7(1):31. doi: 10.1038/s41572-021-00265-2.
Background: PubMed 25193672Holz FG, Tadayoni R, Beatty S, Berger A, Cereda MG, Cortez R, Hoyng CB, Hykin P, Staurenghi G, Heldner S, Bogumil T, Heah T, Sivaprasad S. Multi-country real-life experience of anti-vascular endothelial growth factor therapy for wet age-related macular degeneration. Br J Ophthalmol. 2015 Feb;99(2):220-6. doi: 10.1136/bjophthalmol-2014-305327. Epub 2014 Sep 5.
Background: PubMed 29376143Cabral T, Lima LH, Mello LGM, Polido J, Correa EP, Oshima A, Duong J, Serracarbassa P, Regatieri CV, Mahajan VB, Belfort R Jr. Bevacizumab Injection in Patients with Neovascular Age-Related Macular Degeneration Increases Angiogenic Biomarkers. Ophthalmol Retina. 2018 Jan;2(1):31-37. doi: 10.1016/j.oret.2017.04.004.
Individual participant dataSharing planned: No

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 3 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: opening soon, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

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?

Adverse Event (time frame: 4 weeks). 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 NCT06022744, which also lists 9 linked publications.

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 5 Sep 2023.