Actively Recruiting

Phase 1
Phase 2
Age: 50Years - 85Years
All Genders
NCT07185841

Safety and Efficacy of Oral HX9428 Tablets in Subjects With Wet Age-related Macular Degeneration (wAMD)

Led by Fujian Haixi Pharmaceuticals Co., Ltd. · Updated on 2025-09-25

198

Participants Needed

1

Research Sites

183 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of Oral HX9428 tablets in patients with wet age-related macular degeneration(wAMD)

CONDITIONS

Official Title

Safety and Efficacy of Oral HX9428 Tablets in Subjects With Wet Age-related Macular Degeneration (wAMD)

Who Can Participate

Age: 50Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 50 to 80 years (Phase I) or 50 to 85 years (Phase II) at the time of informed consent, male or female
  • Active choroidal neovascularization secondary to AMD confirmed by fluorescein fundus angiography and optical coherence tomography
  • Total lesion size less than 12 disc areas on fluorescein fundus angiography
  • Treatment-naive or previously treated with effective anti-VEGF therapy discontinued for more than 3 months with OCT evidence of subretinal fluid or cystoid macular edema
  • ETDRS best corrected visual acuity between 19 and 78 letters (about 20/32 to 20/400 Snellen equivalent)
  • Other protocol-specified inclusion criteria may apply
Not Eligible

You will not qualify if you...

  • Polypoidal choroidal vasculopathy diagnosed by Indocyanine Green angiography with high risk of massive hemorrhage
  • Subretinal hemorrhage greater than 50% of total lesion area or involving the fovea on fluorescein fundus angiography or color fundus photography
  • Fibrosis or atrophy greater than 50% of total lesion area or involving the fovea
  • Choroidal neovascularization due to causes other than AMD
  • Any condition in the study eye that could impair best-corrected visual acuity
  • Active ocular inflammation or infection in either eye or history of idiopathic or autoimmune-related uveitis
  • Refractive error exceeding -6.00 diopters spherical equivalent
  • Ocular surgery in the study eye within 90 days before screening
  • Previous photodynamic therapy within 120 days, external-beam radiotherapy, macular laser photocoagulation, macular surgery, or transpupillary thermotherapy
  • Systemic anti-VEGF therapy within 90 days before first dose
  • Pregnant or lactating women
  • Known hypersensitivity or contraindication to study-related drugs or procedures
  • History of severe cardiac disease, symptomatic heart failure, unstable angina, acute coronary syndrome, myocardial infarction, coronary revascularization, thrombotic or bleeding event within 6 months before study drug start
  • Uncontrolled hypertension (systolic >150 mmHg or diastolic >100 mmHg on optimal therapy)
  • Ventricular arrhythmia requiring ongoing treatment
  • Stroke within 12 months or transient ischemic attack within 6 months before enrollment
  • Poorly controlled diabetes (HbA1c ≥ 12%)
  • Other protocol-specified exclusion criteria may apply

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Beijing Hospital

Beijing, China, 100010

Actively Recruiting

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Research Team

J

Junqing Li

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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