NCT05562219

QA108 Phase II Study in Subjects With Intermediate Age-Related Macular Degeneration

A Randomized, Double-Masked, Placebo-Controlled, Multicenter, Phase II Clinical Study of the Efficacy and Safety of QA108 Granules in the Treatment of Intermediate Age-Related Macular Degeneration

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Smilebiotek Zhuhai Limited · Industry
• Sex: All
• Age: 45 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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).

Conditions

• Intermediate Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	QA108 granules	Take the medication as required for 24 weeks
DRUG	QA108 granules placebo	Take the medication as required for 24 weeks

Timeline

• Start date: 2022-06-29
• Primary completion: 2024-06-24
• Completion: 2024-06-24
• First posted: 2022-09-30
• Last updated: 2024-07-15

Locations

1 site across 1 country: China