---
title: Safety and Tolerability of KH658 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
nct_id: NCT06458595
overall_status: RECRUITING
phase: PHASE1, PHASE2
sponsor: Chengdu Origen Biotechnology Co., Ltd.
study_type: INTERVENTIONAL
primary_condition: Age-related Macular Degeneration
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06458595.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06458595"
ct_last_update_post_date: 2024-11-29
last_seen_at: "2026-05-12T07:13:15.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Safety and Tolerability of KH658 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD)

**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).

**NCT ID:** [NCT06458595](https://clinicaltrials.gov/study/NCT06458595)

## Key Facts

- **Status:** RECRUITING
- **Phase:** PHASE1, PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 44
- **Lead Sponsor:** Chengdu Origen Biotechnology Co., Ltd.
- **Conditions:** Age-related Macular Degeneration
- **Start Date:** 2024-06-28
- **Completion Date:** 2026-12-28
- **CT.gov Last Update:** 2024-11-29

## Brief 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.

## Eligibility

- **Minimum age:** 50 Years
- **Maximum age:** 85 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **KH658** (EXPERIMENTAL)

## Interventions

- **KH658** (DRUG) — KH658 Ophthalmic Injection

## Primary Outcomes

- **Tolerability and safety of KH658 in different dose levels** _(time frame: Week 4， Week 26)_
- **Change in BCVA letter** _(time frame: Week 26)_

## 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)_

## Locations (1)

- Tianjin Medical University General Hospital, Tianjin, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `armsInterventions.interventions` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.tianjin medical university general hospital|tianjin||china` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT06458595*  
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