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 range45 Years – 85 Years

SexALL

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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;
✕. Previous ophthalmic surgery in the study eye: vitrectomy, macular translocation;
✕. 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;
✕. Any intraocular surgery (excluding intravitreal injections) that may affect trial observations or imaging in the study eye within 3 months;
✕. Cataract in the study eye that interferes with fundus examination or imaging;
✕. Treatments received in the study eye within 3 months prior to screening, including macular laser photocoagulation and micropulse laser therapy;

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