QA108 Phase III Study in Subjects With Intermediate AMD

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Clinical Study of the Efficacy and Safety of QA108 Granules in the Treatment of Intermediate Age-Related Macular Degeneration (Type of Yang-Hyperactivity Due to Yin-Deficiency)

QA108 Phase III Study in Subjects With Intermediate AMD (NCT07189169) is a Phase 3 interventional studying Intermediate Age-Related Macular Degeneration, sponsored by Smilebiotek Zhuhai Limited. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Intermediate Age-Related Macular Degeneration, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 400 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: 1. The study eye meets the Western medicine diagnostic criteria for intermediate age-related macular degeneration; 2. Presence of at least one large drusen (diameter ≥125 μm) in the macular area of the fundus; 3. Consistent with the TCM diagnosis of type of Yang-hyperactivity due to Yin-deficiency; 4. Age 45-85 years (inclusive), regardless of gender; 5. The study eye has a BCVA of 88-34 letters (using the ETDRS chart, inclusive of threshold values), equivalent to a Snellen visual acuity of 20/20 to 20/200 (inclusive); 6. Voluntary participation in this clinical trial, with willing to sign a consent form provided and an willing to sign a consent form form signed Who Should NOT Join This Trial: 1. The study eye is with concomitant eye disorders that may interfere with the observation of the trial as judged by the investigator, including pathological myopia, glaucoma, diabetic retinopathy, retinal vein occlusion, uveitis, retinal detachment, optic neuropathy (optic neuritis, atrophy, papilledema), and macular hole; 2. The study eye has an intraocular pressure (IOP) ≥ 25 mmHg; 3. Presence of geographic atrophy (GA) involving the foveal center in the study eye; 4. Previous ophthalmic surgery in the study eye: vitrectomy, macular translocation; 5. Aphakia (except pseudophakia) or posterior capsule rupture (except YAG laser posterior capsulotomy after IOL implantation at more than 1 month prior to screening) of the study eye; 6. Any intraocular surgery (excluding intravitreal injections) that may affect trial observations or imaging in the study eye within 3 months; 7. Cataract in the study eye that interferes with fundus examination or imaging; 8. Treatments received in the study eye within 3 months prior to screening, including macular laser photocoagulation and micropulse laser therapy; 9. The patient received relevant TCM treatment within 1 month prior to screening; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. The study eye meets the Western medicine diagnostic criteria for intermediate age-related macular degeneration; 2. Presence of at least one large drusen (diameter ≥125 μm) in the macular area of the fundus; 3. Consistent with the TCM diagnosis of type of Yang-hyperactivity due to Yin-deficiency; 4. Age 45-85 years (inclusive), regardless of gender; 5. The study eye has a BCVA of 88-34 letters (using the ETDRS chart, inclusive of threshold values), equivalent to a Snellen visual acuity of 20/20 to 20/200 (inclusive); 6. Voluntary participation in this clinical trial, with informed consent provided and an informed consent form signed Exclusion Criteria: 1. The study eye is with concomitant eye disorders that may interfere with the observation of the trial as judged by the investigator, including pathological myopia, glaucoma, diabetic retinopathy, retinal vein occlusion, uveitis, retinal detachment, optic neuropathy (optic neuritis, atrophy, papilledema), and macular hole; 2. The study eye has an intraocular pressure (IOP) ≥ 25 mmHg; 3. Presence of geographic atrophy (GA) involving the foveal center in the study eye; 4. Previous ophthalmic surgery in the study eye: vitrectomy, macular translocation; 5. Aphakia (except pseudophakia) or posterior capsule rupture (except YAG laser posterior capsulotomy after IOL implantation at more than 1 month prior to screening) of the study eye; 6. Any intraocular surgery (excluding intravitreal injections) that may affect trial observations or imaging in the study eye within 3 months; 7. Cataract in the study eye that interferes with fundus examination or imaging; 8. Treatments received in the study eye within 3 months prior to screening, including macular laser photocoagulation and micropulse laser therapy; 9. The patient received relevant TCM treatment within 1 month prior to screening; 10. Active ocular infection in either eye that affects fundus examination or imaging; 11. The non-study eye has a BCVA of less than 19 ETDRS letters (not inclusive); 12. Known allergy to the therapeutic or diagnostic drug used in the study protocol, including the single drug components in the study drugs; 13. Poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg after regular use of antihypertensive drugs); 14. Platelet count ≤100×10⁹/L (unless follow-up results are normal), or any of the following exceeding 1.5 times the upper limit of normal (ULN): total bilirubin (TBIL), alanine aminotransferase (ALT), aspartate aminotransferase (AST), or serum creatinine (Cr); 15. Pregnant women, women who are breastfeeding, those who plan for pregnancy in the next six months, or those who are unwilling to take effective birth controls during the study course and until six months after drug withdrawal; 16. Any uncontrollable clinical disorder prior to the start of treatment, such as severe psychiatric, neurological, respiratory, immunological, hematological, and cardiac system diseases, and malignant tumors; 17. Subjects who have participated in other clinical trials within 3 months prior to this trial; 18. Patients who are unsuitable for participating at the discretion of the investigator.

Treatments Being Tested

DRUG

QA108 granules

Take the medication as required for 24 weeks

DRUG

QA108 granules placebo

Take the medication as required for 24 weeks

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Beijing Hospital

Beijing, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07189169), the sponsor (Smilebiotek Zhuhai Limited), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07189169 clinical trial studying?

This is a phase III randomized, double-masked, placebo-controlled, multicenter study. To evaluate the efficacy and safety of QA108 granules in the treatment of intermediate age-related macular degeneration. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07189169?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07189169?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07189169. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07189169. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.