Actively Recruiting
QA108 Phase III Study in Subjects With Intermediate AMD
Led by Smilebiotek Zhuhai Limited · Updated on 2025-09-23
400
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
QA108 Phase III Study in Subjects With Intermediate AMD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The study eye meets the Western medicine diagnostic criteria for intermediate age-related macular degeneration
- Presence of at least one large drusen (diameter 65125 bcm) 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
You will not qualify if you...
- The study eye has other eye disorders that may interfere with the trial, such as pathological myopia, glaucoma, diabetic retinopathy, retinal vein occlusion, uveitis, retinal detachment, optic neuropathy, and macular hole
- The study eye has intraocular pressure 6525 mmHg
- Presence of geographic atrophy involving the foveal center in the study eye
- Previous ophthalmic surgery in the study eye like vitrectomy or macular translocation
- Aphakia (except pseudophakia) or posterior capsule rupture (except certain YAG laser capsulotomy) in the study eye
- Any intraocular surgery (excluding intravitreal injections) within 3 months prior to screening
- Cataract in the study eye that interferes with fundus examination or imaging
- Treatments like macular laser photocoagulation received in the study eye within 3 months prior to screening
- Relevant traditional Chinese medicine treatment within 1 month prior to screening
- Active ocular infection in either eye affecting fundus examination or imaging
- The non-study eye has BCVA less than 19 ETDRS letters
- Known allergy to drugs used in the study protocol
- Poorly controlled hypertension (systolic 65160 mmHg or diastolic 65100 mmHg after treatment)
- Low platelet count or abnormal liver/kidney function tests
- Pregnant, breastfeeding, planning pregnancy, or unwilling to use birth control during and 6 months after the study
- Uncontrollable severe clinical disorders such as psychiatric, neurological, respiratory, immunological, hematological, cardiac diseases, or malignant tumors
- Participation in other clinical trials within 3 months prior
- Deemed unsuitable by the investigator for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Hospital
Beijing, China
Actively Recruiting
Research Team
H
Hong Dai
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
2
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