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QA102 200mg group for Age-Related Macular Degeneration (AMD)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Age-Related Macular Degeneration (AMD)QA102 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Age-Related Macular Degeneration (AMD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
ASP7317
1
OpRegen
1
Cohort 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Month 1,2,3,6,9,12,15,18,21,24

Month 1,2,3,6,9,12,15,18,21,24
Area under the curve for BCVA letters read on the ETDRS chart over the 24-month treatment period
Change from Baseline in GA area
Change from Baseline in soft drusen (drusen volume, drusen size)
change from Baseline in BCVA
Month 24
Changes from baseline in gut microbiota
proportion of subjects with disease progression to CNV or significant GA change as defined in the protocol
at ≥3 time points
The estimated mean rate of growth (slope) based on GA area

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
ASP7317
2
OpRegen
1
Cohort 3

Trial Design

3 Treatment Groups

QA102 200mg group
1 of 3
QA102 400mg group
1 of 3
Placebo group
1 of 3

Experimental Treatment

Non-Treatment Group

240 Total Participants · 3 Treatment Groups

Primary Treatment: QA102 200mg group · Has Placebo Group · Phase 2

QA102 200mg group
Drug
Experimental Group · 1 Intervention: QA102/Placebo · Intervention Types: Drug
QA102 400mg group
Drug
Experimental Group · 1 Intervention: QA102 · Intervention Types: Drug
Placebo group
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
QA102
2021
Completed Phase 1
~70

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: month 1,2,3,6,9,12,15,18,21,24

Who is running the clinical trial?

Smilebiotek Zhuhai LimitedLead Sponsor
2 Previous Clinical Trials
189 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be at least 50 years old to give informed consent.
Subject must be able to take oral medications and willing to record daily adherence to taking their assigned capsules.
You have adequate hematologic function, hepatic function, renal function and coagulation profile as defined in the protocol.
You are willing and able to comply with study procedures and examinations.
You have 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.
You are able to correctly identify 35 letters.
Subjects must have had a diagnosis of advanced AMD (GA or CNV) within the 12 months prior to screening.
References

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