Safety and Tolerability of KH658 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD)

November 26, 2024 updated by: Chengdu Origen Biotechnology Co., Ltd.

A Phase I/II Study to Evaluate the Tolerability, Safety and Efficacy of KH658 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD).

KH658 is a adeno-associated virus (AAV) vector-based gene therapy for suprachoroidal space injection. The long-term, stable therapeutic protein after one time injection for nAMD could potentially reduce the treatment burden and maintain vision.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

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

Study Contact

Study Locations

  • China
      • Tianjin, China
        • Recruiting
        • Tianjin Medical University General Hospital
        • Contact:
          • Hua Yan, M.D.

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. Are willing and able to sign the informed consent form (ICF);
  2. Female and male aged 50 to 85 years (inclusive) with nAMD;
  3. Have previously received anti-VEGF treatment for nAMD, with documented response to anti-VEGF therapy and a minimum of 2 anti-VEGF IVT injections in the study eye in the 6 months prior to screening;
  4. Have a ETDRS BCVA letter score of 83 to 19 (approximately 20/25 to 20/400 Snellen equivalent) in the study eye at Screening;
  5. Have a ETDRS BCVA letter score of ≥19 in the fellow eye at Screening;
  6. Females must be at least 1 year postmenopausal.

Exclusion Criteria:

  1. Have any other cause of CNV (such as pathological myopia, etc.) in the study eye; or non-nAMD disease in the study eye judged by the investigator that could impact macular examination or affect central vision (such as diabetic retinopathy, central retinal vein occlusion, etc.);
  2. Any condition preventing visual acuity improvement in the study eye, e.g. fovea scar, fibrosis or atrophy;
  3. Have a subretinal hemorrhage that is either 50% or more of the total lesion area, or blood is greater than 1.0 mm2 under the fovea in the study eye at screening;
  4. Have any vitreous hemorrhage or history of vitreous hemorrhage in the study eye;
  5. Presence of an implant (excluding intraocular lens), opacification of the refractive medium or miosis that affects fundus examination;
  6. Have a history of or presence of retinal detachment or choroidal detachment in the study eye.

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: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: KH658
Drug: KH658
KH658 Ophthalmic Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tolerability and safety of KH658 in different dose levels
Time Frame: Week 4， Week 26
Week 4， Week 26
Change in BCVA letter
Time Frame: Week 26
Week 26

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events and adverse reactions
Time Frame: Week 4， 26， 38， 54
Week 4， 26， 38， 54
Efficacy (BCVA, CRT)
Time Frame: Week 38， 54
Week 38， 54
Number of supplemental injections
Time Frame: Week 54
Week 54
Annualized rate of supplemental injections
Time Frame: Week 54
Week 54
Percentage of subjects free of rescue IVT therapy
Time Frame: Week 54
Week 54

Collaborators and Investigators

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

Sponsor

Chengdu Origen Biotechnology Co., Ltd.

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)

June 28, 2024

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

December 28, 2026

Study Registration Dates

First Submitted

June 9, 2024

First Submitted That Met QC Criteria

June 9, 2024

First Posted (Actual)

June 13, 2024

Study Record Updates

Last Update Posted (Actual)

November 29, 2024

Last Update Submitted That Met QC Criteria

November 26, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KH658-40101

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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