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Gene Therapy

Gene Therapy for Age-Related Macular Degeneration

Phase 1

Recruiting

Research Sponsored by Chengdu Origen Biotechnology Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 104 weeks

Awards & highlights

Study Summary

This trial is testing a gene therapy to reduce the need for frequent injections for neovascular AMD: a one-time treatment that blocks VEGF to improve vision & reduce fluid.

Who is the study for?

This trial is for men and women aged 50 to 85 with neovascular Age-related Macular Degeneration (AMD) who've had some improvement from previous anti-VEGF treatments. They must have a certain level of vision in the affected eye and be able to undergo high-quality imaging. Those with recent eye surgery, other causes of CNV, or long-term intraocular steroid use can't participate.Check my eligibility

What is being tested?

KH631 gene therapy is being tested for safety and tolerability in this Phase I trial. It's designed as a one-time treatment delivering a protein that blocks VEGF, which could potentially reduce the need for regular eye injections currently used to treat neovascular AMD.See study design

What are the potential side effects?

As this is an early-stage trial focusing on safety, specific side effects are not listed but may include typical risks associated with gene therapy such as immune reactions, inflammation at the injection site, or changes in vision.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 104 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~104 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 104 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety (Type, Severity and Incidence of ocular and systemic AEs and SAEs)

Secondary outcome measures

Best Corrected Visual Acuity

Rescue Injections

Safety (type, severity and incidence of ocular and systemic AEs and SAEs)

Trial Design

5Treatment groups

Experimental Treatment

Group I: KH631 Dose 5Experimental Treatment1 Intervention

KH631 One-Time Intraocular Injection Dose Level 5

Group II: KH631 Dose 4Experimental Treatment1 Intervention

KH631 One-Time Intraocular Injection Dose Level 4

Group III: KH631 Dose 3Experimental Treatment1 Intervention

KH631 One-Time Intraocular Injection Dose Level 3

Group IV: KH631 Dose 2Experimental Treatment1 Intervention

KH631 One-Time Intraocular Injection Dose Level 2

Group V: KH631 Dose 1Experimental Treatment1 Intervention

KH631 One-Time Intraocular Injection Dose Level 1

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Chengdu Origen Biotechnology Co., Ltd.Lead Sponsor

1 Previous Clinical Trials

42 Total Patients Enrolled

Avner Ingerman, MD, MScStudy DirectorVanotech Ltd.

Media Library

KH631 (Gene Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05657301 — Phase 1

Age-Related Macular Degeneration Research Study Groups: KH631 Dose 5, KH631 Dose 1, KH631 Dose 2, KH631 Dose 3, KH631 Dose 4

Age-Related Macular Degeneration Clinical Trial 2023: KH631 Highlights & Side Effects. Trial Name: NCT05657301 — Phase 1

KH631 (Gene Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05657301 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research include individuals who are over 45 years of age?

"To qualify for this medical trial, participants must be between the ages of 50 and 85 years old. For those younger than 18 or older than 65, there are 8 clinical trials available to them in total; 171 specifically cater to seniors."

Answered by AI

Is KH631 Dose 1 safe to use for individuals?

"As KH631 Dose 1 is currently in Phase 1 of its medical trial, there remains limited evidence regarding safety and efficacy. Therefore, our team at Power rated the drug's safety a level 1 on the three-point scale."

Answered by AI

What is the size of the population being examined in this research?

"Affirmative. According to clinicaltrials.gov, this medical investigation is still recruiting participants and was first published on August 1st 2023, with the most recent update occurring on August 17th 2023. A total of 25 patients are needed for the trial at one site in particular."

Answered by AI

What qualifications must a person possess to be eligible for this clinical research?

"Eligibility for this medical trial requires that participants have age-related macular degeneration and are between the ages of 50 to 85. There is a total of 25 available spots in the study."

Answered by AI

Is enrollment currently available for this research study?

"Affirmative. Clinicaltrials.gov data reveals that this research endeavour, which was first uploaded on August 1st 2023, is still actively seeking volunteers. Approximately 25 people need to be recruited from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Tolerability of KH631 Gene Therapy in Participants With Neovascular Age-related Macular Degeneration

2023. "Safety and Tolerability of KH631 Gene Therapy in Participants With Neovascular Age-related Macular Degeneration". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05657301.