Age-related Macular DegenerationPhase 1/2NCT06458595
Safety and Tolerability of KH658 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
A Phase 1/2 study testing KH658 in people with Age-related Macular Degeneration, run by Chengdu Origen Biotechnology Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Age-related Macular Degeneration
- What is being tested?
- KH658
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 28 Jun 2024to 28 Dec 2026
- Phase
- Phase 1/2
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are willing and able to sign the informed consent form (ICF);
- Female and male aged 50 to 85 years (inclusive) with nAMD;
- 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;
- Have a ETDRS BCVA letter score of 83 to 19 (approximately 20/25 to 20/400 Snellen equivalent) in the study eye at Screening;
- Have a ETDRS BCVA letter score of ≥19 in the fellow eye at Screening;
- Females must be at least 1 year postmenopausal.
Who cannot join
- 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.);
- Any condition preventing visual acuity improvement in the study eye, e.g. fovea scar, fibrosis or atrophy;
- 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;
- Have any vitreous hemorrhage or history of vitreous hemorrhage in the study eye;
- Presence of an implant (excluding intraocular lens), opacification of the refractive medium or miosis that affects fundus examination;
- Have a history of or presence of retinal detachment or choroidal detachment in the study eye.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University General Hospital
Tianjin
Hua Yan, M.D.
About this study
Official title: 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.
- Conditions
- Age-related Macular Degeneration
- Being tested
- KH658
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KH658Drug
KH658 Ophthalmic Injection
| Study group | Role | What they receive |
|---|---|---|
| KH658 | Experimental | Not described Receives: Drug: KH658 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability and safety of KH658 in different dose levels
Measured: Week 4， Week 26
Change in BCVA letter
Measured: Week 26
Secondary outcomes (5)
Incidence of adverse events and adverse reactions
Measured: Week 4， 26， 38， 54
Efficacy (BCVA, CRT)
Measured: Week 38， 54
Number of supplemental injections
Measured: Week 54
Annualized rate of supplemental injections
Measured: Week 54
Percentage of subjects free of rescue IVT therapy
Measured: Week 54
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start28 Jun 2024
- Primary completion31 Mar 2026 (estimated)
- Study completion28 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Macular DegenerationStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Origen Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458595
- Sponsor's protocol ID
- KH658-40101
- Status last verified
- Jun 2024
- First submitted
- 9 Jun 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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).
- ClinicalTrials.gov ID
- NCT06458595
- Acronym / sponsor ID
- KH658-40101
- Conditions
- Age-related Macular Degeneration
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Chengdu Origen Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Jun 2024 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 28 Dec 2026 (estimated)
- First posted
- 13 Jun 2024 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KH658 | Experimental | Drug: KH658 |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Are willing and able to sign the informed consent form (ICF);
- Female and male aged 50 to 85 years (inclusive) with nAMD;
- 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;
- Have a ETDRS BCVA letter score of 83 to 19 (approximately 20/25 to 20/400 Snellen equivalent) in the study eye at Screening;
- Have a ETDRS BCVA letter score of ≥19 in the fellow eye at Screening;
Key exclusion criteria (6 listed)
- 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.);
- Any condition preventing visual acuity improvement in the study eye, e.g. fovea scar, fibrosis or atrophy;
- 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;
- Have any vitreous hemorrhage or history of vitreous hemorrhage in the study eye;
- Presence of an implant (excluding intraocular lens), opacification of the refractive medium or miosis that affects fundus examination;
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 |
|---|---|---|
| KH658KH658 Ophthalmic Injection | Drug | KH658 |
Primary outcome
Tolerability and safety of KH658 in different dose levels
Time frame: Week 4， Week 26
Change in BCVA letter
Time frame: Week 26
5 secondary outcomes
Incidence of adverse events and adverse reactions
Time frame: Week 4， 26， 38， 54
Efficacy (BCVA, CRT)
Time frame: Week 38， 54
Number of supplemental injections
Time frame: Week 54
Annualized rate of supplemental injections
Time frame: Week 54
Percentage of subjects free of rescue IVT therapy
Time frame: Week 54
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 29 Nov 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing KH658 in people with Age-related Macular Degeneration, run by Chengdu Origen Biotechnology Co., Ltd. at 1 site in China.
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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Jiarong Du (+86176 0288 9310, 026117@cnkh.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability and safety of KH658 in different dose levels (time frame: Week 4， Week 26). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Nov 2024.