Study to Evaluate Suprachoroidally Administered CLS-AX in the Treatment of Neovascular Age-Related Macular Degeneration

Neovascular Age-related Macular Degeneration Clinical Trial

— ODYSSEY  

Official title:

ODYSSEY: A Phase 2b Study of Suprachoroidally Administered CLS-AX in Participants With Neovascular Age-Related Macular Degeneration

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05891548
• Other study ID #: CLS1002-202
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 31, 2023
• Est. completion date: July 2024

Study information

• Verified date: November 2023
• Source: Clearside Biomedical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• CLS-AX
CLS-AX will be administered by suprachoroidal injection into the study eye on Day 1 and then every 12 to 24 weeks as determined by protocol-defined disease activity criteria.
• Aflibercept
Aflibercept will be administered by intravitreal injection into the study eye once every 8 weeks (Q8W).

Locations

Country	Name	City	State
United States	Retina Research Institute of Texas	Abilene	Texas
United States	Texas Retina Associates - Arlington	Arlington	Texas
United States	Western Carolina Retinal Associates P.A.	Asheville	North Carolina
United States	Southeast Retina Center	Augusta	Georgia
United States	Austin Retina	Austin	Texas
United States	California Retina Consultants	Bakersfield	California
United States	Retina Consultants of Texas-Bellairre	Bellaire	Texas
United States	Envision Ocular LLC	Bloomfield	New Jersey
United States	Texas Retina Associates - Dallas	Dallas	Texas
United States	Wolfe Eye Clinic	Des Moines	Iowa
United States	Retina Group of Washington	Fairfax	Virginia
United States	Retina Group of Florida	Fort Lauderdale	Florida
United States	Retina Consultants of Orange County	Fullerton	California
United States	Cumberland Valley Retina Consultants	Hagerstown	Maryland
United States	Retina Consultants of Texas - Katy	Katy	Texas
United States	Florida Retina Consultants	Lakeland	Florida
United States	Georgia Retina, PC	Marietta	Georgia
United States	Northern California Retina Vitreous Associates Medical Group, Inc	Mountain View	California
United States	Tennessee Retina PC	Nashville	Tennessee
United States	Illinois Retina Associates	Oak Park	Illinois
United States	Retina Specialty Institute	Pensacola	Florida
United States	Associated Retina Consultants	Phoenix	Arizona
United States	Retinal Research Institute, LLC	Phoenix	Arizona
United States	Texas Retina Associates-Plano	Plano	Texas
United States	Retina Consultants San Diego	Poway	California
United States	Retinal Consultants of Southern California	Redlands	California
United States	Sierra Eye Associates	Reno	Nevada
United States	Retinal Consultants Medical Group, Inc.	Sacramento	California
United States	Retina Consultants of Texas-San Antonio	San Antonio	Texas
United States	Spokane Eye Clinical Research	Spokane	Washington
United States	Retina Associates of Florida	Tampa	Florida
United States	Vitreo-Retinal Associates, PC	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Clearside Biomedical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluations of Outcomes Related to ETDRS BCVA in the Study Eye Over Time	Best Corrected Visual Acuity (BCVA) letter score measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting test distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score attainable). An increase in BCVA letter score from baseline indicates an improvement in visual acuity.	Baseline, Weeks 4, 12, 16, 20, 24, 28, 32 and 36
Secondary	Evaluations of Outcomes Related to Fluid Detected on Optical Coherence Tomography in the Study Eye Over Time	Spectral-domain optical coherence tomography (SD-OCT) is a non-invasive diagnostic technique that provides high-resolution, cross-sectional tissue imaging and analysis of structural changes in the eye during disease progression. A central reading center will provide measurements and standardized gradings of outcomes related to retinal thickness and fluid in the eye, respectively.; Central subfield retinal thickness (CST) is defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE) in millimeters in the circular region centered on the anatomic fovea with a radius of 500 microns.; The presence and location of intraretinal and subretinal fluid in the central subfield (center 1 mm) is graded as Absent (the best grade attainable); Definite, outside center subfield; Definite, center subfield involved; and Definite, both center subfield and outer subfields involved.	Baseline, Weeks 4, 12, 16, 20, 24, 28, 32 and 36
Secondary	Evaluations of Outcomes Related to Lesion Size on Fundus Fluorescein Angiography in the Study Eye Over Time	Fundus fluorescein angiography (FFA) is an invasive diagnostic procedure used to assess the anatomy, physiology, and pathology of retinal and choroidal circulation. It involves injecting fluorescein dye into a vein in the arm/hand and taking pictures as it circulates through the eye. A central reading center will provide measurements of outcomes related to the size of lesions/leakage in the eye.; Total area of Choroidal Neovascularization (CNV) includes classic and occult components and ranges from 0-42 mm2, with 0 mm2 being the best measurement attainable.; Total lesion area includes the total CNV and associated lesion components and ranges from 0-42 mm2, with 0 mm2 being the best measurement attainable.; Total area of leakage includes the total area leakage from neovascularization and ranges from 0-42 mm2, with 0 mm2 being the best measurement attainable.	Baseline, Week 36
Secondary	Evaluation of the Number of Study Drug Injections and Supplemental Therapy Injections in the Study Eye Over Time	Number of masked study drug injections and supplemental therapy injections administered in the study eye.	From Baseline Through Week 36
Secondary	Evaluation of Serious Adverse Events (SAEs) and Treatment-Emergent Adverse Events (TEAEs)	The analysis of serious adverse events (SAEs) includes both ocular and non-ocular (systemic) adverse events (AEs) meeting SAE criteria as defined in International Conference on Harmonisation (ICH) E6 Good Clinical Practice Consolidated Guidance. TEAEs are defined as adverse events that emerge during or after treatment with masked treatment having been absent pre-treatment or worsens relative to the pre-treatment state.; Investigators will seek information on AEs at each contact with the participant. All AEs are recorded and the Investigator will independently assess seriousness, severity, and causality of each AE.	From first dose of masked study drug through the end of the study (up to 36 weeks)