Clinical trial NCT05891548: Study to Evaluate Suprachoroidally Administered CLS-AX in the Treatment of Neovascular Age-Related Macular Degeneration
Official title: ODYSSEY: A Phase 2b Study of Suprachoroidally Administered CLS-AX in Participants With Neovascular Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neovascular Age-related Macular Degeneration
Keywords: AMD
Wet AMD
Suprachoroidal
Tyrosine kinase inhibitor
Microinjector
Suprachoroidal Space (SCS)
Lead sponsor: Clearside Biomedical, Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-07
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to one of two treatment groups in parallel for the duration of the study.
Primary purpose: TREATMENT

Brief summary: Phase 2b, randomized, double-masked, parallel-group, active-controlled, multicenter, 36-week study designed to assess the safety and efficacy of suprachoroidally administered CLS-AX 1.0 mg with a flexible dosing regimen in participants with neovascular age-related macular degeneration previously treated with intravitreal anti-vascular endothelial growth factor (VEGF) standard of care therapy. Only one eye will be chosen as the study eye.

Detailed description: Phase 2b, randomized, double-masked, parallel-group, active-controlled, multicenter, 36-week study designed to assess the safety and efficacy of suprachoroidally administered CLS-AX 1.0 mg with a flexible dosing regimen in participants with neovascular age-related macular degeneration previously treated with intravitreal anti-VEGF standard of care therapy. Active-control will be 2 mg intravitreal injections of aflibercept dosed per the EYLEA Prescribing Information. Only one eye will be chosen as the study eye.

Eligibility criteria: Key Inclusion Criteria:

* Diagnosis of neovascular age-related macular degeneration (nAMD) in the study eye within 36 months of Visit 1.
* Subfoveal choroidal neovascularization (CNV) secondary to nAMD of any lesion type in the study eye that shows total lesion area ≤30 mm2, CNV component area of ≥50% of the total lesion area, and and CNV must not be associated with subfoveal hemorrhage, subfoveal fibrosis, or subfoveal atrophy.
* Previous treatment in the study eye with between 2 and 4 anti-VEGF intravitreal injections for nAMD (faricimab, ranibizumab, bevacizumab, brolucizumab, or aflibercept) per standard of care within 6 months of Visit 1.
* History of response to prior intravitreal anti-VEGF treatment in the study eye.
* ETDRS BCVA of between 20 and 80 letters (inclusive) in the study eye.

Key Exclusion Criteria:

* ETDRS BCVA \<20 letters in the study eye.
* Central subfield thickness \> 400 μm or retinal pigment epithelium detachment thickness \>400 μm on SD-OCT in the study eye.
* Subretinal hemorrhage, fibrosis or atrophy of \>50% of the total lesion area and/or that involves the fovea on fundus fluorescein angiography and/or color fundus photography in the study eye.
* CNV due to causes other than AMD, such are ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, or uveitis, in the study eye.
* Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid in the study eye.

Primary outcomes:
measure: Evaluations of Outcomes Related to ETDRS BCVA in the Study Eye Over Time
timeFrame: Baseline, Weeks 4, 12, 16, 20, 24, 28, 32 and 36
Secondary outcomes:
measure: Evaluations of Outcomes Related to Fluid Detected on Optical Coherence Tomography in the Study Eye Over Time
timeFrame: Baseline, Weeks 4, 12, 16, 20, 24, 28, 32 and 36
measure: Evaluations of Outcomes Related to Lesion Size on Fundus Fluorescein Angiography in the Study Eye Over Time
timeFrame: Baseline, Week 36
measure: Evaluation of the Number of Study Drug Injections and Supplemental Therapy Injections in the Study Eye Over Time
timeFrame: From Baseline Through Week 36
measure: Evaluation of Serious Adverse Events (SAEs) and Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From first dose of masked study drug through the end of the study (up to 36 weeks)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Associated Retina Consultants
state: Arizona
city: Phoenix
country: United States
facility: Retinal Research Institute, LLC
state: Arizona
city: Bakersfield
country: United States
facility: California Retina Consultants
state: California
city: Fullerton
country: United States
facility: Retina Consultants of Orange County
state: California
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates Medical Group, Inc
state: California
city: Poway
country: United States
facility: Retina Consultants San Diego
state: California
city: Redlands
country: United States
facility: Retinal Consultants of Southern California
state: California
city: Sacramento
country: United States
facility: Retinal Consultants Medical Group, Inc.
state: California
city: Fort Lauderdale
country: United States
facility: Retina Group of Florida
state: Florida
city: Lakeland
country: United States
facility: Florida Retina Consultants
state: Florida
city: Pensacola
country: United States
facility: Retina Specialty Institute
state: Florida
city: Tampa
country: United States
facility: Retina Associates of Florida
state: Florida
city: Augusta
country: United States
facility: Southeast Retina Center
state: Georgia
city: Marietta
country: United States
facility: Georgia Retina, PC
state: Georgia
city: Oak Park
country: United States
facility: Illinois Retina Associates
state: Illinois
city: Des Moines
country: United States
facility: Wolfe Eye Clinic
state: Iowa
city: Hagerstown
country: United States
facility: Cumberland Valley Retina Consultants
state: Maryland
city: Worcester
country: United States
facility: Vitreo-Retinal Associates, PC
state: Massachusetts
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Bloomfield
country: United States
facility: Envision Ocular LLC
state: New Jersey
city: Asheville
country: United States
facility: Western Carolina Retinal Associates P.A.
state: North Carolina
city: Nashville
country: United States
facility: Tennessee Retina PC
state: Tennessee
city: Abilene
country: United States
facility: Retina Research Institute of Texas
state: Texas
city: Arlington
country: United States
facility: Texas Retina Associates - Arlington
state: Texas
city: Austin
country: United States
facility: Austin Retina
state: Texas
city: Bellaire
country: United States
facility: Retina Consultants of Texas-Bellairre
state: Texas
city: Dallas
country: United States
facility: Texas Retina Associates - Dallas
state: Texas
city: Katy
country: United States
facility: Retina Consultants of Texas - Katy
state: Texas
city: Plano
country: United States
facility: Texas Retina Associates-Plano
state: Texas
city: San Antonio
country: United States
facility: Retina Consultants of Texas-San Antonio
state: Texas
city: Fairfax
country: United States
facility: Retina Group of Washington
state: Virginia
city: Spokane
country: United States
facility: Spokane Eye Clinical Research
state: Washington
Study officials:
affiliation: Clearside Biomedical, Inc.
name: Susan Coultas, PhD
role: STUDY_DIRECTOR
References: