Extension Study to Evaluate the Long-term Outcomes of Subjects in the CLS-AX CLS1002-101 Study

Neovascular Age-related Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05131646
• Other study ID #: CLS1002-102
• Status: Completed
• Start date: October 8, 2021
• Est. completion date: January 5, 2023

Study information

• Verified date: February 2023
• Source: Clearside Biomedical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 5, 2023
• Est. primary completion date: January 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration

Intervention

Drug:
• CLS-AX
injectable suspension of small molecule tyrosine kinase inhibitor (TKI) administered in the Parent study CLS1002-101

Locations

Country	Name	City	State
United States	Southeast Retina Center	Augusta	Georgia
United States	Retina Consultants of Texas	Bellaire	Texas
United States	Cumberland Valley Retina Consultants	Hagerstown	Maryland
United States	Northern California Retina Vitreous Associates Medical Group, LLC	Mountain View	California
United States	Retinal Consultants of Arizona	Phoenix	Arizona
United States	Retina Consultants Medical Group, Inc	Sacramento	California
United States	Retina Consultants of Texas	The Woodlands	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Clearside Biomedical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants Qualifying to Receive Additional Intravitreal (IVT) Aflibercept Injections	Number of participants qualifying to receive additional intravitreal aflibercept injections during the course of the study. Criteria included 1) loss of 10 or more letters in BCVA compared to the best prior study-assessed BCVA in the study eye that was attributed to intra- or sub-retinal fluid, 2) increase in central subfield thickness >75 microns from Baseline in the study eye, or 3) presence of vision-threatening hemorrhage due to AMD in the study eye.	Day 1 to Week 24
Other	Mean Change From Baseline in Pre-Injection Intraocular Pressure (IOP)	Intraocular pressure (IOP) is a diagnostic measurement of the fluid pressure, measured in millimeters of mercury, inside the eye. IOP was measured using Goldmann applanation tonometry or by use of a Tonopen tonometer. Normal eye pressure is usually considered to be between 10 and 20 mmHg (AAO.org). Untreated elevated eye pressure is a risk factor for glaucoma.	Weeks 4, 8, 12, 16, 20 and 24
Primary	Number of Participants With Treatment-emergent Adverse Events (TEAEs)	The number of participants with treatment-emergent adverse events (TEAEs) reported between the administration of CLS-AX and study exit.	Day 1 to Week 24
Primary	Number of Participants With Serious Adverse Events (SAEs)	The number of participants with serious adverse events (SAEs) reported between the administration of CLS-AX and study exit.	Day 1 to Week 24
Secondary	Mean Change From Baseline in Central Subfield Thickness (CST) in the Study Eye	Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A central reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema. Only images that were gradable by the central reading center were included in the analysis.	Weeks 4, 8, 12, 16, 20 and 24
Secondary	Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye	BCVA measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting test distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.	Weeks 4, 8, 12, 16, 20 and 24
Secondary	Number of Participants Receiving Additional Intravitreal (IVT) Aflibercept Injections	Number of participants receiving additional intravitreal aflibercept injections during the course of the study for nAMD.	Day 1 to Week 24