QA108 Phase II Study in Subjects With Intermediate Age-Related Macular Degeneration (NCT05562219) | Clinical Trial Compass
CompletedPhase 2
QA108 Phase II Study in Subjects With Intermediate Age-Related Macular Degeneration
China120 participantsStarted 2022-06-29
Plain-language summary
This is a phase 2, 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 is diagnosed by western medicine with intermediate age-related macular degeneration, i.e., at least one large drusen (≥ 125 μm in diameter) is visible within two papillary diameters (PD) away from the fovea;
. Consistent with the TCM diagnosis of type of Yang-hyperactivity due to Yin-deficiency;
. Age 45 to 85 years old (both inclusive), male or female;
. The study eye has a BCVA of 83-34 ETDRS letters (inclusive), which is equivalent to a Snellen visual acuity of 20/25 to 20/200 (inclusive);
. The subject is voluntary to participate in this clinical study, provide informed consent, and sign the informed consent form.
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;
. The study eye is presented with GA;
. Previous ophthalmic surgery in the study eye: vitrectomy, macular translocation;
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.
. 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 or periocular surgery of the study eye and intraocular surgery (except eyelid surgery) of the non-study eye within 3 months;
. The study eye is diagnosed with cataract affecting fundus observation, which may require cataract surgery within 6 months at the discretion of the investigator;
. The study eye has received the following treatment within 3 months prior to screening: macular laser photocoagulation and micro-pulse laser therapy;