Oral HX9428 tablets for wet age-related macular degeneration

A Multicenter, Open-label, Phase I/II Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Oral HX9428 Tablets in Subjects With Wet Age-related Macular Degeneration (wAMD)

This study will test whether daily or every-other-day oral HX9428 tablets are safe and can help people aged 50–85 with active wet age-related macular degeneration.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 198 (estimated)
• Ages: 50 Years to 85 Years
• Sex: All
• Sponsor: Fujian Haixi Pharmaceuticals Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing)
• Trial ID: NCT07185841 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label Phase I/II study tests oral HX9428 tablets in adults with active wet AMD, measuring safety, tolerability, pharmacokinetics and preliminary efficacy. Phase I uses a 3+3 dose-escalation design with single and multiple oral doses to establish the maximum tolerated dose and characterize PK. If efficacy signals appear in Phase I, a parallel Phase II may run with dosing once daily or every other day not to exceed the Phase I MTD. Primary outcomes include adverse events, PK parameters, OCT measures of retinal fluid, and changes in best-corrected visual acuity.

Who should consider this trial

Good fit: Ideal candidates are adults aged 50–85 with active choroidal neovascularization from wet AMD, OCT evidence of subretinal or intraretinal fluid, lesion size under 12 disc areas, and visual acuity roughly between 20/32 and 20/400, including treatment‑naive patients or those who stopped anti‑VEGF therapy more than 3 months ago.

Not a fit: Patients with inactive/quiescent AMD, very large lesions (>12 disc areas), recent anti‑VEGF treatment within 3 months, vision outside the study range, or other protocol exclusions are unlikely to benefit.

Why it matters

Potential benefit: If successful, an effective oral HX9428 could offer a non-invasive treatment to reduce retinal fluid and help preserve or improve vision, potentially reducing the need for injections.

How similar studies have performed: Oral systemic treatments for wet AMD are relatively novel and prior oral agents have had limited success, so this approach remains experimental.

Eligibility criteria

Inclusion Criteria:

* Participants must meet the following criteria for study entry:

  1. Age ≥50 years and ≤80 years (Phase I), Age ≥50 years and ≤85 years (Phase II) at the time of signing informed consent, male or female;
  2. Active choroidal neovascularization (CNV) secondary to AMD, as evidenced on fluorescein fundus angiography (FFA) and optical coherence tomography (OCT) (Active CNV is defined as the presence of subretinal or intraretinal fluid or leakage); A total lesion size of \<12 disc areas on FFA ;
  3. Treatment-naive , or previous anti-VEGF treatment that was effective and discontinued for more than 3 months, with OCT evidence of subretinal fluid or cystoid macular edema;
  4. ETDRS BCVA 19 to 78 letters in the study eyes( corresponding to a Snellen equivalent of approximately 20/32 to 20/400) ;
  5. Other protocol-specified inclusion criteria may apply

Exclusion Criteria:

* Subjects who meet any of the following criteria will be excluded from this study:

  1. Subjects diagnosed with polypoidal choroidal vasculopathy by Indocyanine Green(ICG) angiography who are at high risk of massive hemorrhage;
  2. On FFA/CFP: subretinal hemorrhage of \>50 % of the total lesion area or that involves the fovea; fibrosis or atrophy of \>50 % of the total lesion area or that involves the fovea;
  3. CNV due to causes other than AMD;
  4. Any condition in the study eye that could compromise best-corrected visual acuity;
  5. Active ocular inflammation or infection in either eye or a history of idiopathic or autoimmune-related uveitis;
  6. Refractive error exceeding -6.00 D spherical equivalent;
  7. Ocular surgery performed in the study eye within 90 days before screening;
  8. Previous treatment with photodynamic therapy (within 120 days of screening), external-beam radiotherapy, macular laser photocoagulation, macular surgery, or transpupillary thermotherapy;
  9. Systemic anti-VEGF therapy administered within 90 days before the first dose;
  10. Pregnant or lactating women;
  11. Known hypersensitivity or contraindication to any study-related procedure drugs;
  12. History of severe cardiac disease, symptomatic congestive heart failure, unstable angina, acute coronary syndrome, myocardial infarction, coronary revascularization, thrombotic event, or bleeding episode within 6 months prior to the start of study drug, uncontrolled hypertension (systolic blood pressure\> 150 mmHg and/or diastolic blood pressure \> 100 mmHg on optimal medical therapy), or ventricular arrhythmia requiring ongoing treatment;
  13. Stroke within 12 months or transient ischemic attack within 6 months of enrolment；
  14. Poorly controlled diabetes (HbA1c ≥ 12 %);
  15. Other protocol-specified exclusion criteria may apply.

Where this trial is running

Beijing

• Beijing Hospital — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Hong Dai — Beijing Hospital
• Study coordinator: Junqing Li

Conditions Wet Age-related Macular Degeneration