Could a simple pill help save sight in wet AMD?
NCT ID NCT07185841
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests an experimental oral tablet called HX9428 for people with wet age-related macular degeneration (AMD), a leading cause of vision loss. The trial will enroll 198 adults aged 50–85 to check the drug's safety, how the body processes it, and whether it can improve eyesight or reduce retinal fluid. Participants take the pill by mouth, aiming to offer a more convenient alternative to standard eye injections.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 198 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Hospital
RECRUITINGBeijing, 100010, China