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

NCT05891548 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: CLS1002-202
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 32

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.

Conditions

Neovascular Age-related Macular Degeneration

Keywords

AMD; Wet AMD; Suprachoroidal; Tyrosine kinase inhibitor; Microinjector; Suprachoroidal Space (SCS)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Evaluations of Outcomes Related to Fluid Detected on Optical Coherence Tomography in the Study Eye Over Time

  Baseline, Weeks 4, 12, 16, 20, 24, 28, 32 and 36

• Evaluations of Outcomes Related to Lesion Size on Fundus Fluorescein Angiography in the Study Eye Over Time

  Baseline, Week 36

• Evaluation of the Number of Study Drug Injections and Supplemental Therapy Injections in the Study Eye Over Time

  From Baseline Through Week 36

• Evaluation of Serious Adverse Events (SAEs) and Treatment-Emergent Adverse Events (TEAEs)

  From first dose of masked study drug through the end of the study (up to 36 weeks)

Study Arms (2)

1.0 mg CLS-AX

EXPERIMENTAL

Suprachoroidal injection of 10 mg/mL (1.0 mg in 0.1 mL) of CLS-AX

Drug: CLS-AX

Aflibercept

ACTIVE COMPARATOR

Intravitreal injection of aflibercept (2 mg in 0.05 mL)

Drug: Aflibercept

Interventions

CLS-AX DRUG

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.

Also known as: axitinib injectable suspension

1.0 mg CLS-AX

Aflibercept DRUG

Aflibercept will be administered by intravitreal injection into the study eye once every 8 weeks (Q8W).

Also known as: Eylea

Aflibercept

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clearside Biomedical, Inc.: lead

Study Sites (32)

Associated Retina Consultants

Phoenix, Arizona, 85020, United States

Location

Retinal Research Institute, LLC

Phoenix, Arizona, 85053, United States

Location

California Retina Consultants

Bakersfield, California, 93309, United States

Location

Retina Consultants of Orange County

Fullerton, California, 92835, United States

Location

Northern California Retina Vitreous Associates Medical Group, Inc

Mountain View, California, 94040, United States

Location

Retina Consultants San Diego

Poway, California, 92064, United States

Location

Retinal Consultants of Southern California

Redlands, California, 92374, United States

Location

Retinal Consultants Medical Group, Inc.

Sacramento, California, 95825, United States

Location

Retina Group of Florida

Fort Lauderdale, Florida, 33308, United States

Location

Florida Retina Consultants

Lakeland, Florida, 33805, United States

Location

Retina Specialty Institute

Pensacola, Florida, 32503, United States

Location

Retina Associates of Florida

Tampa, Florida, 33609, United States

Location

Southeast Retina Center

Augusta, Georgia, 30909, United States

Location

Georgia Retina, PC

Marietta, Georgia, 30060, United States

Location

Illinois Retina Associates

Oak Park, Illinois, 60304, United States

Location

Wolfe Eye Clinic

Des Moines, Iowa, 50266, United States

Location

Cumberland Valley Retina Consultants

Hagerstown, Maryland, 21740, United States

Location

Vitreo-Retinal Associates, PC

Worcester, Massachusetts, 01605, United States

Location

Sierra Eye Associates

Reno, Nevada, 89431, United States

Location

Envision Ocular LLC

Bloomfield, New Jersey, 07003, United States

Location

Western Carolina Retinal Associates P.A.

Asheville, North Carolina, 28803, United States

Location

Tennessee Retina PC

Nashville, Tennessee, 37203, United States

Location

Retina Research Institute of Texas

Abilene, Texas, 79606, United States

Location

Texas Retina Associates - Arlington

Arlington, Texas, 76012, United States

Location

Austin Retina

Austin, Texas, 78705, United States

Location

Retina Consultants of Texas-Bellairre

Bellaire, Texas, 77401, United States

Location

Texas Retina Associates - Dallas

Dallas, Texas, 75231, United States

Location

Retina Consultants of Texas - Katy

Katy, Texas, 77494, United States

Location

Texas Retina Associates-Plano

Plano, Texas, 75075, United States

Location

Retina Consultants of Texas-San Antonio

San Antonio, Texas, 78240, United States

Location

Retina Group of Washington

Fairfax, Virginia, 22031, United States

Location

Spokane Eye Clinical Research

Spokane, Washington, 99204, United States

Location

MeSH Terms

Conditions

Choroidal Effusions

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Eye Abnormalities; Eye Diseases; Choroid Diseases; Uveal Diseases

Study Officials

• Susan Coultas, PhD

  Clearside Biomedical, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned to one of two treatment groups in parallel for the duration of the study.

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 7, 2023
• Study Start: May 31, 2023
• Primary Completion: August 20, 2024
• Study Completion: August 20, 2024
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (32)