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) (AMEND)

  • STATUS
    Recruiting
  • End date
    Oct 21, 2025
  • participants needed
    240
  • sponsor
    Smilebiotek Zhuhai Limited
Updated on 21 October 2022

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.

Description

Approximately 30 sites will randomize a total of approximately 240 subjects to 1 of 3 treatment arms in a 1:1:1 ratio (80 subjects per arm). Each subject will receive either QA102 or matching placebo BID for up to 24 months.

Details
Condition Dry Age-related Macular Degeneration
Treatment Placebo, QA102, QA102/Placebo
Clinical Study IdentifierNCT05536752
SponsorSmilebiotek Zhuhai Limited
Last Modified on21 October 2022

Eligibility

Yes No Not Sure

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

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
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