N/A
N=15
Extension Study to Evaluate the Long-term Outcomes of Subjects in the CLS-AX CLS1002-101 Study
Neovascular Age-related Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT05131646 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) — 3; 2; 1 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- CLS-AX (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Clearside Biomedical, Inc.
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
3; 2; 1 | — |
| PRIMARY Number of Participants With Serious Adverse Events (SAEs) |
0; 0; 0 | — |
| SECONDARY Mean Change From Baseline in Central Subfield Thickness (CST) in the Study Eye |
14.7; 23.5; 20.2; 5.7; 28.2; 13.6 | — |
| SECONDARY Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye |
0.7; 1.0; 0.8; -2.3; 2.5; 1.8 | — |
| SECONDARY Number of Participants Receiving Additional Intravitreal (IVT) Aflibercept Injections |
1; 0; 1; 1; 0; 0 | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT05131646). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.