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QA102 Phase II Study in Subjects With Dry AMD (AMEND)

Primary Purpose

Dry Age-related Macular Degeneration

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
QA102/Placebo
QA102
Placebo
Sponsored by
Smilebiotek Zhuhai Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Age-related Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Texas Retina Associates - Plano

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

QA102 200mg group

QA102 400mg group

Placebo group

Arm Description

Subjects randomized to this arm will receive one (1) 200 mg capsule of QA102 and 1 placebo capsule BID = daily dose of 400 mg QA102 for up to 24 months

Subjects randomized to this arm will receive two (2) 200 mg capsules of QA102 BID = daily dose of 800 mg QA102 for up to 24 months

Subjects randomized to this arm will receive two (2) placebo capsules BID = daily dose of 0 mg QA102 for up to 24 months

Outcomes

Primary Outcome Measures

proportion of subjects with disease progression to CNV or significant GA change as defined in the protocol
In the study eye at Month 24, proportion of subjects with disease progression as defined in the protocol.

Secondary Outcome Measures

change from Baseline in BCVA
change from Baseline in best-corrected visual acuity (BCVA) as measured by Early Treatment Diabetic Retinopathy Study (ETDRS).
The estimated mean rate of growth (slope) based on GA area
The estimated mean rate of growth (slope) based on GA area measured by FAF at ≥3 time points.
Change from Baseline in soft drusen (drusen volume, drusen size)
Change from Baseline in soft drusen (drusen volume, drusen size) as measured by SD-OCT
Change from Baseline in GA area
Change of Baseline GA area to on-treatment GA area assessments
Area under the curve for BCVA letters read on the ETDRS chart over the 24-month treatment period
Change from baseline BCVA letters read on the ETDRS chart to on-treatment assessments

Full Information

First Posted
September 8, 2022
Last Updated
August 3, 2023
Sponsor
Smilebiotek Zhuhai Limited
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1. Study Identification

Unique Protocol Identification Number
NCT05536752
Brief Title
QA102 Phase II Study in Subjects With Dry AMD
Acronym
AMEND
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 22, 2022 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Smilebiotek Zhuhai Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 GA or CNV in high-risk eyes.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Age-related Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
145 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
QA102 200mg group
Arm Type
Experimental
Arm Description
Subjects randomized to this arm will receive one (1) 200 mg capsule of QA102 and 1 placebo capsule BID = daily dose of 400 mg QA102 for up to 24 months
Arm Title
QA102 400mg group
Arm Type
Experimental
Arm Description
Subjects randomized to this arm will receive two (2) 200 mg capsules of QA102 BID = daily dose of 800 mg QA102 for up to 24 months
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Subjects randomized to this arm will receive two (2) placebo capsules BID = daily dose of 0 mg QA102 for up to 24 months
Intervention Type
Drug
Intervention Name(s)
QA102/Placebo
Intervention Description
Capsules
Intervention Type
Drug
Intervention Name(s)
QA102
Intervention Description
Capsules
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsules
Primary Outcome Measure Information:
Title
proportion of subjects with disease progression to CNV or significant GA change as defined in the protocol
Description
In the study eye at Month 24, proportion of subjects with disease progression as defined in the protocol.
Time Frame
Month 24
Secondary Outcome Measure Information:
Title
change from Baseline in BCVA
Description
change from Baseline in best-corrected visual acuity (BCVA) as measured by Early Treatment Diabetic Retinopathy Study (ETDRS).
Time Frame
Month 1,2,3,6,9,12,15,18,21,24
Title
The estimated mean rate of growth (slope) based on GA area
Description
The estimated mean rate of growth (slope) based on GA area measured by FAF at ≥3 time points.
Time Frame
at ≥3 time points
Title
Change from Baseline in soft drusen (drusen volume, drusen size)
Description
Change from Baseline in soft drusen (drusen volume, drusen size) as measured by SD-OCT
Time Frame
Month 1,2,3,6,9,12,15,18,21,24
Title
Change from Baseline in GA area
Description
Change of Baseline GA area to on-treatment GA area assessments
Time Frame
Month 1,2,3,6,9,12,15,18,21,24
Title
Area under the curve for BCVA letters read on the ETDRS chart over the 24-month treatment period
Description
Change from baseline BCVA letters read on the ETDRS chart to on-treatment assessments
Time Frame
Month 1,2,3,6,9,12,15,18,21,24
Other Pre-specified Outcome Measures:
Title
Changes from baseline in gut microbiota
Time Frame
Month 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lai Wei, MD
Organizational Affiliation
Chief Scientific Officer
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Retina Associates - Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States

12. IPD Sharing Statement

Learn more about this trial

QA102 Phase II Study in Subjects With Dry AMD

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