QA102 Phase II Study in Subjects With Dry AMD

• Status: Not yet recruiting
• Trial end date: 2025-10-01
• Target enrollment: 0
• Participant gender: All

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 GA or CNV in high-risk eyes.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Smilebiotek Zhuhai Limited

Criteria

Key Inclusion Criteria:

• Subject must be able to understand and willing to sign a written informed consent form (ICF) prior to the initiation of any study-specific procedures.

• Subject must be age ≥50 years at the time of informed consent.

• Subject must be able to take oral medications and willing to record daily adherence to taking their assigned capsules.

• Subject must have adequate hematologic function, hepatic function, renal function and coagulation profile as defined in the protocol.

• Subject must be willing and able to comply with study procedures and examinations.

Specific to the Study Eye:

• Subject must have one of the following:

• extensive intermediate-size drusen, or at least 1 large drusen, or

• at least one GA secondary to AMD, with very limited aggregate size of total GA(s), as defined in the protocol.

• Subject must be able to correctly identify ≥35 ETDRS letters (approximately 20/200 Snellen equivalent).

Specific to Fellow Eye:

• Subject must have had a diagnosis of advanced AMD (GA or CNV) within the 12 months prior to screening.

Specific to Both Eyes:

• Subject must have visualizable retina, clear ocular media, and adequate pupillary dilation to ensure high-quality fundus imaging.

Key Exclusion Criteria:

• Subject participated in another clinical study within 6 weeks prior to Screening.

• Subject is unwilling to stop intake of Age-Related Eye Disease Studies (AREDS) vitamins for the duration of the study.

• Subject has a clinically significant systemic disease that might interfere with the study, in the judgment of the Investigator.

• Subject had major surgery within 30 days prior to Screening.

Specific to Study Eye:

• Subject has large GA, subfoveal GA, or active or inactive CNV, as confirmed by the CRC.

• Subject has GA or CNV due to causes other than AMD that that developed between Visit 1 (Screening) and Visit 2 (Randomization).

• Subject has endophthalmitis.

Specific to Either Eye:

• Subject had intraocular surgery with lens replacement within 3 months of Screening.

• Subject has any ophthalmic condition that could require surgery during the study period.

• Subject has an ocular condition that might affect adequate imaging of the retina and/or or alter visual acuity.