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 range45 Years – 85 Years
SexALL
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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;
✕. 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;