RecruitingPhase 3

QA108 Phase III Study in Subjects With Intermediate AMD

China400 participantsStarted 2025-07-08

Plain-language summary

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.

Who can participate

Age range

45 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. The study eye meets the Western medicine diagnostic criteria for intermediate age-related macular degeneration;
. Presence of at least one large drusen (diameter ≥125 μm) in the macular area of the fundus;
. Consistent with the TCM diagnosis of type of Yang-hyperactivity due to Yin-deficiency;
. Age 45-85 years (inclusive), regardless of gender;
. 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);
. Voluntary participation in this clinical trial, with informed consent provided and an informed consent form signed

Exclusion criteria

. 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;
. The study eye has an intraocular pressure (IOP) ≥ 25 mmHg;
. Presence of geographic atrophy (GA) involving the foveal center in the study eye;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage change from baseline in drusen area

Timeframe: weeks 24

Trial details

NCT IDNCT07189169

SponsorSmilebiotek Zhuhai Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03-01

Contact for this trial

Hong Dai

010-85132171 Dai-hong@x263.net

View on ClinicalTrials.gov More Intermediate Age-Related Macular Degeneration trials