Back to resultsStudy to Evaluate Suprachoroidally Administered CLS-AX in the Treatment of Neovascular Age-Related Macular Degeneration (ODYSSEY)
Primary Purpose
Neovascular Age-related Macular Degeneration
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CLS-AX
Aflibercept
Sponsored by
About this trial
This is an interventional treatment trial for Neovascular Age-related Macular Degeneration focused on measuring AMD, Wet AMD, Suprachoroidal, Tyrosine kinase inhibitor, Microinjector, Suprachoroidal Space (SCS)
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.
Sites / Locations
- Associated Retina ConsultantsRecruiting
- Retinal Research Institute, LLCRecruiting
- California Retina ConsultantsRecruiting
- Retina Consultants of Orange CountyRecruiting
- Northern California Retina Vitreous Associates Medical Group, IncRecruiting
- Retina Consultants San DiegoRecruiting
- Retinal Consultants of Southern CaliforniaRecruiting
- Retinal Consultants Medical Group, Inc.Recruiting
- Retina Group of FloridaRecruiting
- Florida Retina ConsultantsRecruiting
- Retina Specialty InstituteRecruiting
- Retina Associates of FloridaRecruiting
- Southeast Retina CenterRecruiting
- Georgia Retina, PCRecruiting
- Illinois Retina AssociatesRecruiting
- Wolfe Eye ClinicRecruiting
- Cumberland Valley Retina ConsultantsRecruiting
- Vitreo-Retinal Associates, PCRecruiting
- Sierra Eye AssociatesRecruiting
- Envision Ocular LLCRecruiting
- Western Carolina Retinal Associates P.A.Recruiting
- Tennessee Retina PCRecruiting
- Retina Research Institute of TexasRecruiting
- Texas Retina Associates - ArlingtonRecruiting
- Austin RetinaRecruiting
- Retina Consultants of Texas-BellairreRecruiting
- Texas Retina Associates - DallasRecruiting
- Retina Consultants of Texas - KatyRecruiting
- Texas Retina Associates-PlanoRecruiting
- Retina Consultants of Texas-San AntonioRecruiting
- Retina Group of WashingtonRecruiting
- Spokane Eye Clinical ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1.0 mg CLS-AX
Aflibercept
Arm Description
Suprachoroidal injection of 10 mg/mL (1.0 mg in 0.1 mL) of CLS-AX
Intravitreal injection of aflibercept (2 mg in 0.05 mL)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT05891548
First Posted
May 24, 2023
Last Updated
September 21, 2023
Sponsor
Clearside Biomedical, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05891548
Brief Title
Study to Evaluate Suprachoroidally Administered CLS-AX in the Treatment of Neovascular Age-Related Macular Degeneration
Acronym
ODYSSEY
Official Title
ODYSSEY: A Phase 2b Study of Suprachoroidally Administered CLS-AX in Participants With Neovascular Age-Related Macular Degeneration
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2023 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clearside Biomedical, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Age-related Macular Degeneration
Keywords
AMD, Wet AMD, Suprachoroidal, Tyrosine kinase inhibitor, Microinjector, Suprachoroidal Space (SCS)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomly assigned to one of two treatment groups in parallel for the duration of the study.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The participant, Sponsor, Principal (non-injecting) Investigator, medical monitor, study coordinator, visual acuity technician, photographer, central reading center, and central laboratory will be masked to treatment assignment for the duration of the study.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1.0 mg CLS-AX
Arm Type
Experimental
Arm Description
Suprachoroidal injection of 10 mg/mL (1.0 mg in 0.1 mL) of CLS-AX
Arm Title
Aflibercept
Arm Type
Active Comparator
Arm Description
Intravitreal injection of aflibercept (2 mg in 0.05 mL)
Intervention Type
Drug
Intervention Name(s)
CLS-AX
Other Intervention Name(s)
axitinib injectable suspension
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Aflibercept
Other Intervention Name(s)
Eylea
Intervention Description
Aflibercept will be administered by intravitreal injection into the study eye once every 8 weeks (Q8W).
Primary Outcome Measure Information:
Title
Evaluations of Outcomes Related to ETDRS BCVA in the Study Eye Over Time
Description
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.
Time Frame
Baseline, Weeks 4, 12, 16, 20, 24, 28, 32 and 36
Secondary Outcome Measure Information:
Title
Evaluations of Outcomes Related to Fluid Detected on Optical Coherence Tomography in the Study Eye Over Time
Description
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.
Time Frame
Baseline, Weeks 4, 12, 16, 20, 24, 28, 32 and 36
Title
Evaluations of Outcomes Related to Lesion Size on Fundus Fluorescein Angiography in the Study Eye Over Time
Description
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.
Time Frame
Baseline, Week 36
Title
Evaluation of the Number of Study Drug Injections and Supplemental Therapy Injections in the Study Eye Over Time
Description
Number of masked study drug injections and supplemental therapy injections administered in the study eye.
Time Frame
From Baseline Through Week 36
Title
Evaluation of Serious Adverse Events (SAEs) and Treatment-Emergent Adverse Events (TEAEs)
Description
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.
Time Frame
From first dose of masked study drug through the end of the study (up to 36 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Donna Bezner, M.S.
Phone
404.850.3421
Email
donna.bezner@clearsidebio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Coultas, PhD
Organizational Affiliation
Clearside Biomedical, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Associated Retina Consultants
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Retinal Research Institute, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
California Retina Consultants
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Retina Consultants of Orange County
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Northern California Retina Vitreous Associates Medical Group, Inc
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Retina Consultants San Diego
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Retinal Consultants of Southern California
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Retinal Consultants Medical Group, Inc.
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Retina Group of Florida
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Florida Retina Consultants
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Retina Specialty Institute
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Retina Associates of Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Southeast Retina Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Georgia Retina, PC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Illinois Retina Associates
City
Oak Park
State/Province
Illinois
ZIP/Postal Code
60304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Wolfe Eye Clinic
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Cumberland Valley Retina Consultants
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Vitreo-Retinal Associates, PC
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Sierra Eye Associates
City
Reno
State/Province
Nevada
ZIP/Postal Code
89431
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Envision Ocular LLC
City
Bloomfield
State/Province
New Jersey
ZIP/Postal Code
07003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Western Carolina Retinal Associates P.A.
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Tennessee Retina PC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Retina Research Institute of Texas
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Texas Retina Associates - Arlington
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Austin Retina
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Retina Consultants of Texas-Bellairre
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Texas Retina Associates - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Retina Consultants of Texas - Katy
City
Katy
State/Province
Texas
ZIP/Postal Code
77494
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Texas Retina Associates-Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Retina Consultants of Texas-San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Retina Group of Washington
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Spokane Eye Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Evaluate Suprachoroidally Administered CLS-AX in the Treatment of Neovascular Age-Related Macular Degeneration
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