Clinical trial NCT05536752: QA102 Phase II Study in Subjects With Dry AMD
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Age-related Macular Degeneration
Lead sponsor: Smilebiotek Zhuhai Limited
Sponsor class: INDUSTRY
First posted: 2022-09-13
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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
  * GA ((not involving the foveal center point) 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 a diagnosis of advanced AMD (evidence of GA and/or CNV), to be confirmed by the CRC.

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 received an active investigational drug within 6 weeks (or 5 half-lives of the active, whichever is longer) prior to screening for this QA102 study.
* Subject has ever received gene therapy (for any condition).
* 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.
* Subject has a hemorrhagic or serous pigment epithelial detachment (PED) within 500 µm of the foveal center point, to be confirmed by the CRC.
* Subject has had retinal procedures or surgeries, or has a retinal pathology, such as a macular hole.
* Subject has aphakia or absence of the posterior capsule.
* Subject has ever received, whether in an interventional trial or by prescription, an FDA- approved treatment for GA. Use of such treatment during the QA102 study period also is prohibited. (Study Eye Only)

Specific to Fellow Eye:

Subject has monocular vision impairment, defined as having no light perception in the fellow eye with adequate vision in the study eye.

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.

Primary outcomes:
measure: Change from baseline in soft drusen volume (mm3)
timeFrame: Month 12
Secondary outcomes:
measure: Change from Baseline in BCVA
timeFrame: Month 12
measure: Change from Baseline in LLVA
timeFrame: Month 12
measure: Change from baseline in soft drusen volume (mm3)
timeFrame: Month 1,2,3,6,9,12,15
measure: Change from Baseline in BCVA
timeFrame: Month 1,2,3,6,9,12,15
measure: Change from Baseline in LLVA
timeFrame: Month 1,2,3,6,9,12,15
measure: Change from baseline in GA
timeFrame: Month 1,2,3,6,9,12,15
measure: Change from baseline in GA
timeFrame: Month 1,2,3,6,9,12,15
measure: Mean rate of GA growth
timeFrame: Month 1,2,3,6,9,12,15
measure: Area under the curve for BCVA letters
timeFrame: Month 1,2,3,6,9,12,15
measure: Proportion of subjects with disease progression
timeFrame: Month 15
measure: Proportion of subjects with progression of GA
timeFrame: Month 1,2,3,6,9,12,15
measure: Rescue injections
timeFrame: Month 1,2,3,6,9,12,15
measure: iRORA
timeFrame: Month 1,2,3,6,9,12,15
measure: Fellow eye CNV
timeFrame: Month 1,2,3,6,9,12,15
Other outcomes:
Locations:
city: Plano
country: United States
facility: Texas Retina Associates - Plano
state: Texas
Study officials:
References: