BridgeMD
Tests treatment safety and results for Wet Age-related Macular Degeneration (AMD)
Official title Safety and Efficacy of Oral HX9428 Tablets in Subjects With Wet Age-related Macular Degeneration (wAMD)
ClinicalTrials.gov ID: NCT07185841
What this study is testing
What is HX9428 tablet?
HX9428 tablet is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for wet age-related macular degeneration (amd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of Oral HX9428 tablets in patients with wet age-related macular degeneration(wAMD)
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 85
You may be able to join if
- Participants must meet the following criteria for study entry:
- 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;
- Active choroidal neovascularization (CNV) secondary to AMD, as evidenced on fluorescein fundus angiography (FFA) and optical coherence tomography...
- Treatment-naive , or previous anti-VEGF treatment that was effective and discontinued for more than 3 months, with OCT evidence of subretinal fluid...
- ETDRS BCVA 19 to 78 letters in the study eyes( corresponding to a Snellen equivalent of approximately 20/32 to 20/400) ;
You likely can't join if
- people who meet any of the following criteria will be excluded from this study:
- people diagnosed with polypoidal choroidal vasculopathy by Indocyanine Green(ICG) angiography who are at high risk of massive hemorrhage;
- 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...
- CNV due to causes other than AMD;
- Any condition in the study eye that could compromise best-corrected visual acuity;
- Active ocular inflammation or infection in either eye or a history of idiopathic or autoimmune-related uveitis;
See the full eligibility criteria
- Participants must meet the following criteria for study entry:
- 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;
- 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...
- 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;
- ETDRS BCVA 19 to 78 letters in the study eyes( corresponding to a Snellen equivalent of approximately 20/32 to 20/400) ;
- Other protocol-specified may apply
- people who meet any of the following criteria will be excluded from this study:
- people diagnosed with polypoidal choroidal vasculopathy by Indocyanine Green(ICG) angiography who are at high risk of massive hemorrhage;
- 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;
- CNV due to causes other than AMD;
- Any condition in the study eye that could compromise best-corrected visual acuity;
- Active ocular inflammation or infection in either eye or a history of idiopathic or autoimmune-related uveitis;
- Refractive error exceeding -6.00 D spherical equivalent;
- Ocular surgery performed in the study eye within 90 days before screening;
- Previous treatment with photodynamic therapy (within 120 days of screening), external-beam radiotherapy, macular laser photocoagulation, macular surgery, or transpupillary thermotherapy;
- Systemic anti-VEGF therapy administered within 90 days before the first dose;
- Pregnant or lactating women;
- Known hypersensitivity or contraindication to any study-related procedure drugs;
- 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...
- Stroke within 12 months or transient ischemic attack within 6 months of enrolment；
- Poorly controlled diabetes (HbA1c ≥ 12 %);
- Other protocol-specified exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.