Safety and Efficacy Study of LX102-C01 Treatment of Neovascular Age-Related Macular Degeneration (nAMD)

• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05831007
• Collaborator: Innostellar Biotherapeutics (Other)
• Enrollment: 6
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 29.8
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Neovascular Age-related Macular Degeneration	Genetic: LX102-C01 Injection	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: Dec 6, 2021
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LX102-C01 Injection Potential doses: 3E10 vg, 0.06 mL/eye/dose 1E11 vg, 0.06 mL/eye/dose	Genetic: LX102-C01 Injection; Qualified subjects will receive a single unilateral intravitreal injection of LX102-C01 at Day 0 in the trial.

Outcome Measures

Primary Outcome Measures

1. Incidence of adverse events (AEs) [52 weeks]

   Incidence of adverse events (AEs) within 52 weeks of LX102-C01 intravitreal injection at different doses

2. Incidence of serious adverse events (SAEs) [52 weeks]

   Incidence of serious adverse events (SAEs) within 52 weeks of LX102-C01 intravitreal injection at different doses

Secondary Outcome Measures

1. Mean change in BCVA from Baseline [24 weeks, 52weeks]

   BCVA measured by ETDRS

2. Mean change in Central Subfield Thickness (CST) from Baseline [24 weeks, 52 weeks]

   To evaluate the effect of LX102-C01 on CST

3. Mean number of anti-VEGF injections over time [52 weeks]

   Mean number of anti-VEGF injections over time

4. Change of quality of life scores (VFQ-25) from Baseline [52 weeks]

   Changes of VFQ-25 questionaire from Baseline to 52 weeks

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Willing to sign the informed consent, and willing to attend follow-up visits.

2. Age ≥ 50

3. Diagnosis of active CNV secondary to neovascular AMD

4. The study eye must have a best-corrected E-ETDRS visual acuity letter score of less than or equal to 63.

5. Subjects must have received a minimum of 2 injections within 6 months prior to screening.

6. Demonstrated a meaningful response to anti-VEGF therapy

Exclusion Criteria:

1. CNV or macular edema in the study eye secondary to diseases other than nAMD

2. Retinal detachment, uveitis, uncontrolled glaucoma in the study eye, or any condition preventing visual acuity improvement

3. Acute coronary syndrome, myocardial infarction or coronary artery revascularization, CVA, TIA in the last 6 months

4. Uncontrolled hypertension defined as average SBP ≥160 mmHg or an average DBP ≥100 mmHg

5. Uncontrolled diabetes defined as HbA1c >7.5%

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai		China	200080

Sponsors and Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Innostellar Biotherapeutics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xiaodong Sun, PhD, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• ClinicalTrials.gov Identifier: NCT05831007
• Other Study ID Numbers: SHGH-LX102-C01
• First Posted: Apr 26, 2023
• Last Update Posted: Apr 26, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Macular Degeneration; Wet Macular Degeneration

Study Results

No Results Posted as of Apr 26, 2023