Safety and Tolerability Study of Suprachoroidal Injection of CLS-AX Following Anti-VEGF Therapy in Neovascular AMD

NCT04626128 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: CLS1002-101
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 11

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)

Conditions

Neovascular Age-related Macular Degeneration

Keywords

AMD; Wet-AMD; suprachoroidal; tyrosine kinase inhibitor; Microinjector; SCS

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs)

  Number of participants with treatment-emergent adverse events (TEAEs) reported between the administration of CLS-AX and study exit.

  Day 1 to Week 12

• Number of Participants With Serious Adverse Events

  Number of participants with serious adverse events (SAEs) reported between the administration of CLS-AX and study exit.

  Day 1 to Week 12

Secondary Outcomes (6)

• Mean Change From Baseline in Pre Injection Intraocular Pressure (IOP)

  Weeks 4, 8 and 12.

• Number of Participants Receiving Additional Intravitreal (IVT) Aflibercept Injections

  From Day 1 to Week 12

• Number of Participants Qualifying to Receive Additional Intravitreal (IVT) Aflibercept Injections

  Day 1 to Week 12

• Mean Change From Baseline (Visit 2) in Central Subfield Thickness (CST) in the Study Eye

  Weeks 4, 8 and 12

• Mean Change From Baseline (Visit 2) in Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye

  Weeks 4, 8 and 12

Study Arms (4)

Cohort 1 (Low Dose)

EXPERIMENTAL

Subjects will receive a low dose of 0.03 mg CLS-AX

Drug: CLS-AX; Drug: Anti-VEGF

Cohort 2 (Low-mid Dose)

EXPERIMENTAL

Subjects will receive a low-mid dose of 0.10 mg CLS-AX

Drug: CLS-AX; Drug: Anti-VEGF

Cohort 3 (High-mid Dose)

EXPERIMENTAL

Subjects will receive a high-mid dose of 0.50 mg CLS-AX

Drug: CLS-AX; Drug: Anti-VEGF

Cohort 4 (High Dose)

EXPERIMENTAL

Subjects will receive a high-mid dose of 1.0 mg CLS-AX

Drug: CLS-AX; Drug: Anti-VEGF

Interventions

CLS-AX DRUG

injectable suspension of small molecule tyrosine kinase inhibitor (TKI)

Also known as: axitinib injectable suspension

Cohort 1 (Low Dose); Cohort 2 (Low-mid Dose); Cohort 3 (High-mid Dose); Cohort 4 (High Dose)

Anti-VEGF DRUG

Standard of care therapy used to block vascular endothelial growth factor

Also known as: aflibercept (2mg)

Cohort 1 (Low Dose); Cohort 2 (Low-mid Dose); Cohort 3 (High-mid Dose); Cohort 4 (High Dose)

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clearside Biomedical, Inc.: lead

Study Sites (11)

Retinal Consultants of Arizona

Phoenix, Arizona, 85014, United States

Location

California Retina Consultants

Bakersfield, California, 93309, United States

Location

Northern California Retina Vitreous Associates Medical Group, LLC

Mountain View, California, 94040, United States

Location

Retinal Consultants Medical Group

Sacramento, California, 95825, United States

Location

Center for Retina and Macular Disease

Winter Haven, Florida, 33880, United States

Location

Southeast Retina Center

Augusta, Georgia, 30909, United States

Location

Cumberland Valley Retina Consultants

Hagerstown, Maryland, 21740, United States

Location

Austin Retina Associates

Austin, Texas, 78705, United States

Location

Retina Consultants of Texas

Bellaire, Texas, 77401, United States

Location

Retina Consultants of Texas

San Antonio, Texas, 78240, United States

Location

Retina Consultants of Texas

The Woodlands, Texas, 77384, United States

Location

MeSH Terms

Interventions

aflibercept

Results Point of Contact

• Title: Susan Coultas, PhD
• Organization: Clearside Biomedical, Inc.

susan.coultas@clearsidebio.com

678.270.3639

Study Officials

• Susan Coultas, PhD

  Clearside Biomedical, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Four groups of approximately 5 participants are assigned to receive interventions in sequential dose escalation fashion based on prior milestones being reached.

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 12, 2020
• Study Start: December 15, 2020
• Primary Completion: October 13, 2022
• Study Completion: October 13, 2022
• Last Updated: September 18, 2023
• Results First Posted: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)