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

C

Clearside Biomedical

Status and phase

Completed
Phase 2
Phase 1

Conditions

Neovascular Age-related Macular Degeneration

Treatments

Drug: CLS-AX
Drug: Anti-VEGF

Study type

Interventional

Funder types

Industry

Identifiers

NCT04626128
CLS1002-101

Details and patient eligibility

About

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)

Full description

Multi-center, open-label, dose-escalation, phase 1/2a, safety and tolerability study to evaluate four dose groups of suprachoroidally administered CLS-AX following intravitreal anti-VEGF therapy in up to a maximum of 25 subjects with neovascular age-related macular degeneration

Enrollment

27 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

27 participants in 4 patient groups

Cohort 1 (Low Dose)
Experimental group
Description:
Subjects will receive a low dose of 0.03 mg CLS-AX
Treatment:
Drug: Anti-VEGF
Drug: CLS-AX
Cohort 2 (Low-mid Dose)
Experimental group
Description:
Subjects will receive a low-mid dose of 0.10 mg CLS-AX
Treatment:
Drug: Anti-VEGF
Drug: CLS-AX
Cohort 3 (High-mid Dose)
Experimental group
Description:
Subjects will receive a high-mid dose of 0.50 mg CLS-AX
Treatment:
Drug: Anti-VEGF
Drug: CLS-AX
Cohort 4 (High Dose)
Experimental group
Description:
Subjects will receive a high-mid dose of 1.0 mg CLS-AX
Treatment:
Drug: Anti-VEGF
Drug: CLS-AX

Trial documents
1

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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