Phase 2
Completed N=27
Safety and Tolerability Study of Suprachoroidal Injection of CLS-AX Following Anti-VEGF Therapy in Neovascular AMD
Source: ClinicalTrials.gov NCT04626128 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcomePrimary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) — 1; 2; 1; 3 Participants
Summary
To evaluate the safety and tolerability of suprachoroidally administered CLS-AX following intravitreal anti-VEGF therapy in subjects with neovascular age-related macular degeneration (AMD)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
1; 2; 1; 3 | — |
| PRIMARY Number of Participants With Serious Adverse Events |
0; 0; 0; 0 | — |
| SECONDARY Mean Change From Baseline in Pre Injection Intraocular Pressure (IOP) |
-2.8; -1.8; -0.3; 0.0; -3.0; 0.6 | — |
| SECONDARY Number of Participants Receiving Additional Intravitreal (IVT) Aflibercept Injections |
0; 1; 1; 4; 4; 2 | — |
| SECONDARY Number of Participants Qualifying to Receive Additional Intravitreal (IVT) Aflibercept Injections |
0; 1; 1; 3; 4; 2 | — |
| SECONDARY Mean Change From Baseline (Visit 2) in Central Subfield Thickness (CST) in the Study Eye |
22.3; 22.0; 21.1; 26.6; 62.8; 21.8 | — |
| SECONDARY Mean Change From Baseline (Visit 2) in Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye |
4.7; 0.2; -0.6; 1.0; -0.2; -3.6 | — |
| SECONDARY Maximum Plasma Concentration [Cmax] of Axitinib |
0.0101; 0.0264; 0.0749; 0.0602 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of neovascular age-related macular degeneration in the study eye.
- Active subfoveal choroidal neovascularization (CNV) secondary to AMD
- Two or more prior anti-VEGF intravitreal injections
- EDTRS BCVA score ≤ 75 and ≥ 20 letters
Exclusion Criteria
- Any active ocular disease, ocular disorders or conditions, prior ocular surgery or infection in the study eye other than nAMD
- Other than IVT anti-VEGF treatments, no topical ocular or intraocular or periocular corticosteroid, or other treatments for CNV
- IOP ≥ 25mmHg or cup-to-disc ratio >0.8
- Uncontrolled systemic disease (high risk or evidence of arterial and venous thromboembolism, CVA or stroke, unstable cardiovascular disease, uncontrolled hyperthyroidism, poor glycemic control, gastrointestinal bleed and/or high risk of GI perforation or fistula formation) or any other condition or therapy that would make the participant unsuitable for the study
- Currently enrolled in an investigational drug or device study or has used an investigational drug or device within 30 days or the Screening visit
Data sourced from ClinicalTrials.gov (NCT04626128). 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. Informational only — not medical advice.