NCT05536752

QA102 Phase II Study in Subjects With Dry AMD

A Phase 2, Double-Masked, Randomized, Placebo-Controlled, Dose-Response Study Assessing the Safety and Efficacy of QA102 in Subjects With Dry Age-Related Macular Degeneration (AMD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Smilebiotek Zhuhai Limited · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2, double-masked, randomized, placebo-controlled, dose-response study. The primary objective of the study is to evaluate the efficacy of QA102 oral capsules on the development of soft drusen, visual acuity (VA), and geographic atrophy (GA) or choroidal neovascularization (CNV) or the progression of GA in subjects with intermediate to advanced dry AMD.

Detailed description

Approximately 30 sites will randomize a total of approximately 150 subjects to 1 of 3 treatment arms in a 1:1:1 ratio (50 subjects per arm). Each subject will receive either QA102 or matching placebo BID for up to 15 months.

Conditions

• Dry Age-related Macular Degeneration

Interventions

Type	Name	Description
DRUG	QA102/Placebo	Capsules
DRUG	QA102	Capsules
DRUG	Placebo	Capsules

Timeline

• Start date: 2022-09-22
• Primary completion: 2024-11-12
• Completion: 2024-11-12
• First posted: 2022-09-13
• Last updated: 2025-01-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study