Could a simple pill help save sight in wet AMD?

NCT ID NCT07185841

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 198 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

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

50 to 85 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Beijing Hospital

    RECRUITING

    Beijing, 100010, China