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

April 14, 2023 updated by: Xiaodong Sun, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200080
        • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

  1. Age ≥ 50
  2. Diagnosis of active CNV secondary to neovascular AMD
  3. The study eye must have a best-corrected E-ETDRS visual acuity letter score of less than or equal to 63.
  4. Subjects must have received a minimum of 2 injections within 6 months prior to screening.
  5. 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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
52 weeks
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
52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change in BCVA from Baseline
Time Frame: 24 weeks, 52weeks
BCVA measured by ETDRS
24 weeks, 52weeks
Mean change in Central Subfield Thickness (CST) from Baseline
Time Frame: 24 weeks, 52 weeks
To evaluate the effect of LX102-C01 on CST
24 weeks, 52 weeks
Mean number of anti-VEGF injections over time
Time Frame: 52 weeks
Mean number of anti-VEGF injections over time
52 weeks
Change of quality of life scores (VFQ-25) from Baseline
Time Frame: 52 weeks
Changes of VFQ-25 questionaire from Baseline to 52 weeks
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Collaborators

Innostellar Biotherapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2021

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

April 14, 2023

First Submitted That Met QC Criteria

April 14, 2023

First Posted (Actual)

April 26, 2023

Study Record Updates

Last Update Posted (Actual)

April 26, 2023

Last Update Submitted That Met QC Criteria

April 14, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHGH-LX102-C01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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