QA108 treatment for intermediate age-related macular degeneration

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)

This trial will test whether QA108 granules can help people aged 45–85 with intermediate age-related macular degeneration by comparing the granules to a placebo.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 45 Years to 85 Years
• Sex: All
• Sponsor: Smilebiotek Zhuhai Limited (Industry-sponsored)
• Locations: 1 site (Beijing)
• Trial ID: NCT07189169 on ClinicalTrials.gov

What this trial studies

This phase III randomized, double-masked, placebo-controlled multicenter trial compares QA108 granules to placebo in participants with intermediate age-related macular degeneration. Eligible participants must have at least one large druse (≥125 μm) and a best-corrected visual acuity of 88–34 ETDRS letters in the study eye and meet a traditional Chinese medicine diagnosis of Yang-hyperactivity due to Yin-deficiency. Subjects are randomized to receive QA108 granules or matching placebo and are followed for safety and efficacy outcomes related to vision and retinal changes. The trial is sponsored by Smilebiotek Zhuhai Limited with study visits conducted at Beijing Hospital.

Who should consider this trial

Good fit: Adults aged 45–85 with intermediate AMD in the study eye, at least one large druse (≥125 μm), BCVA between 88 and 34 ETDRS letters, and a TCM diagnosis of Yang-hyperactivity due to Yin-deficiency are the intended participants.

Not a fit: Patients with other eye disorders that interfere with observation such as pathological myopia, glaucoma, diabetic retinopathy, retinal vein occlusion, uveitis, retinal detachment, optic neuropathy, those with advanced AMD, or those outside the required age or BCVA ranges are unlikely to benefit from this trial.

Why it matters

Potential benefit: If QA108 is effective, it could slow progression of intermediate AMD and help preserve vision.

How similar studies have performed: Herbal and nutraceutical approaches for AMD have shown mixed results in prior work and QA108 has limited large-scale published evidence, so this approach should be considered relatively novel pending trial results.

Eligibility criteria

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.

Where this trial is running

Beijing

• Beijing Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Hong Dai

Conditions Intermediate Age-Related Macular Degeneration