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
Status: Completed
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:
• Enrolled in and completed the Parent study, CLS1002-101, as part of Cohort 2 or Cohort 3 or Cohort 4.
Locations
United States
Arizona
Retinal Consultants of Arizona
Phoenix
California
Northern California Retina Vitreous Associates Medical Group, LLC
Mountain View
Retina Consultants Medical Group, Inc
Sacramento
Georgia
Southeast Retina Center
Augusta
Maryland
Cumberland Valley Retina Consultants
Hagerstown
Texas
Retina Consultants of Texas
Bellaire
Retina Consultants of Texas
The Woodlands
Time Frame
Start Date: 2021-10-08
Completion Date: 2023-01-05
Participants
Target number of participants: 15
Treatments
Cohort 2 (Low-mid Dose) Extension
Subjects who were administered by suprachoroidal injection 0.10 mg CLS-AX in cohort 2 of the parent study, CLS1002-101, will be followed for an additional 12 weeks following exit from the Parent study. No intervention will be administered in this extension study.
Cohort 3 (High-mid Dose) Extension
Subjects who were administered by suprachoroidal injection 0.50 mg CLS-AX in cohort 3 of the parent study, CLS1002-101, will be followed for an additional 12 weeks following exit from the Parent study. No intervention will be administered in this extension study.
Cohort 4 (High Dose) Extension
Subjects who were administered by suprachoroidal injection 1.0 mg CLS-AX in cohort 4 of the parent study, CLS1002-101, will be followed for an additional 12 weeks following exit from the Parent study. No intervention will be administered in this extension study.
Related Therapeutic Areas
Sponsors
Leads: Clearside Biomedical, Inc.