Clinical trial NCT04626128: Safety and Tolerability Study of Suprachoroidal Injection of CLS-AX Following Anti-VEGF Therapy in Neovascular AMD
Official title: OASIS: Open-label, Dose-escalation, Phase 1/2a Study of the Safety and Tolerability of Suprachoroidally Administered CLS-AX Following Intravitreal Anti-VEGF Therapy in Subjects With Neovascular Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Neovascular Age-related Macular Degeneration
Keywords: AMD
Wet-AMD
suprachoroidal
tyrosine kinase inhibitor
Microinjector
SCS
Lead sponsor: Clearside Biomedical, Inc.
Sponsor class: INDUSTRY
First posted: 2020-11-12
Enrollment: 27
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Four groups of approximately 5 participants are assigned to receive interventions in sequential dose escalation fashion based on prior milestones being reached.
Primary purpose: TREATMENT

Brief 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)

Detailed description: Multi-center, open-label, dose-escalation, phase 1/2a, safety and tolerability study to evaluate four dose groups of suprachoroidally administered CLS-AX following intravitreal anti-VEGF therapy in up to a maximum of 25 subjects with neovascular age-related macular degeneration

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

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: Day 1 to Week 12
measure: Number of Participants With Serious Adverse Events
timeFrame: Day 1 to Week 12
Secondary outcomes:
measure: Mean Change From Baseline in Pre Injection Intraocular Pressure (IOP)
timeFrame: Weeks 4, 8 and 12.
measure: Number of Participants Receiving Additional Intravitreal (IVT) Aflibercept Injections
timeFrame: From Day 1 to Week 12
measure: Number of Participants Qualifying to Receive Additional Intravitreal (IVT) Aflibercept Injections
timeFrame: Day 1 to Week 12
measure: Mean Change From Baseline (Visit 2) in Central Subfield Thickness (CST) in the Study Eye
timeFrame: Weeks 4, 8 and 12
measure: Mean Change From Baseline (Visit 2) in Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye
timeFrame: Weeks 4, 8 and 12
measure: Maximum Plasma Concentration [Cmax] of Axitinib
timeFrame: Day 1 to Week 12
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Retinal Consultants of Arizona
state: Arizona
city: Bakersfield
country: United States
facility: California Retina Consultants
state: California
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates Medical Group, LLC
state: California
city: Sacramento
country: United States
facility: Retinal Consultants Medical Group
state: California
city: Winter Haven
country: United States
facility: Center for Retina and Macular Disease
state: Florida
city: Augusta
country: United States
facility: Southeast Retina Center
state: Georgia
city: Hagerstown
country: United States
facility: Cumberland Valley Retina Consultants
state: Maryland
city: Austin
country: United States
facility: Austin Retina Associates
state: Texas
city: Bellaire
country: United States
facility: Retina Consultants of Texas
state: Texas
city: San Antonio
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: