Clinical trial NCT05131646: Extension Study to Evaluate the Long-term Outcomes of Subjects in the CLS-AX CLS1002-101 Study
Official title: Extension Study to Evaluate the Long-term Outcomes of Subjects Following CLS-AX Administration for Age-related Macular Degeneration in the CLS-AX CLS1002-101 Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neovascular Age-related Macular Degeneration
Keywords: AMD
Wet-AMD
suprachoroidal
tyrosine kinase inhibitor
nAMD
SCS
Lead sponsor: Clearside Biomedical, Inc.
Sponsor class: INDUSTRY
First posted: 2021-11-23
Enrollment: 15
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who completed cohort 2 or 3 or 4 of CLS1002-101

Brief summary: This is an open-label, non-interventional extension study of up to 12 weeks in duration in subjects completing Cohorts 2, 3, and 4 of the Parent study, CLS1002-101.

Detailed description: This is an open-label, non-interventional extension study of up to 12 weeks in duration in subjects completing Cohorts 2. 3 and 4 of the Parent study, CLS1002-101. The Parent study is a 12-week, Phase 1/2a, multicenter study designed to assess the safety and tolerability of a single dose of CLS-AX administered suprachoroidally in subjects with neovascular age-related macular degeneration (nAMD) who show stable visual acuity following 3 or more injections with an intravitreal (IVT) anti-VEGF therapy in the preceding 5 months.

Summary analyses will include 12-weeks data from the Parent study, CLS1002-101, and 12-weeks data from this extension study, CLS1002-102, for a total of 24 weeks follow-up, for all participants enrolled into the extension study.

Eligibility criteria: Inclusion Criteria:

* Enrolled in and completed the Parent study, CLS1002-101, as part of Cohort 2 or Cohort 3 or Cohort 4.

Exclusion Criteria:

* Received prohibited medication in the Parent study, CLS1002-101.
* Enrolled in the Parent study CLS1002-101 as part of Cohort 1.
* Females of childbearing potential who are pregnant and or lactating.

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: Day 1 to Week 24
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: Day 1 to Week 24
Secondary outcomes:
measure: Mean Change From Baseline in Central Subfield Thickness (CST) in the Study Eye
timeFrame: Weeks 4, 8, 12, 16, 20 and 24
measure: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye
timeFrame: Weeks 4, 8, 12, 16, 20 and 24
measure: Number of Participants Receiving Additional Intravitreal (IVT) Aflibercept Injections
timeFrame: Day 1 to Week 24
Other outcomes:
measure: Number of Participants Qualifying to Receive Additional Intravitreal (IVT) Aflibercept Injections
timeFrame: Day 1 to Week 24
measure: Mean Change From Baseline in Pre-Injection Intraocular Pressure (IOP)
timeFrame: Weeks 4, 8, 12, 16, 20 and 24
Locations:
city: Phoenix
country: United States
facility: Retinal Consultants of Arizona
state: Arizona
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates Medical Group, LLC
state: California
city: Sacramento
country: United States
facility: Retina Consultants Medical Group, Inc
state: California
city: Augusta
country: United States
facility: Southeast Retina Center
state: Georgia
city: Hagerstown
country: United States
facility: Cumberland Valley Retina Consultants
state: Maryland
city: Bellaire
country: United States
facility: Retina Consultants of Texas
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Texas
state: Texas
Study officials:
affiliation: Clearside Biomedical, Inc.
name: Susan Coultas, PhD
role: STUDY_DIRECTOR
References: