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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.
Approximately 12 sites will randomize a total of approximately 120 subjects . The subject randomization code table is generated using block randomization. Randomization of not less than 120 cases receiving treatment (treatment and placebo groups) at a ratio of 1:1 for the treatment and control groups.
Clinic study visits will occur on Day -7 to Day -1(Screening/Baseline)(Randomization); Treatment Visits for weeks 4, 8, 12,16,20,and 24 (all ± 3 days); sites will contact each subject to update efficacy date and adverse events (AEs) and review concomitant medications (CMs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group(QA108 granules) | Experimental | QA108 granules, 7.5 g/bag,2 bags/time, BID |
|
| Placebo group(QA108 granule simulants) | Placebo Comparator | QA108 granule simulants, 7.5 g/bag,2 bags/time, BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QA108 granules | Drug | Take the medication as required for 24 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change from baseline in drusen area . |
| weeks 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change from baseline in drusen area | change from baseline in drusen area as measured by optical coherence tomography (OCT) | weeks 4,8,12,16,20 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital (PUMCH) | Beijing | China |
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| QA108 granules placebo |
| Drug |
Take the medication as required for 24 weeks |
|