QA108 Phase III Study in Subjects With Intermediate AMD
Recruiting
Phase 3
Interventional Study
Intermediate Age-Related Macular Degeneration
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 45 – 85
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 400 (estimated)
- Sponsor
- Smilebiotek Zhuhai Limited · Industry
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About This Trial
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.
Trial Locations
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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 du…
Contacts