ClinicalTrials.Veeva

Menu
The trial is taking place at:
R

Retina Consultants San Diego | Poway, CA

Veeva-enabled site

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

C

Clearside Biomedical

Status and phase

Active, not recruiting
Phase 2

Conditions

Neovascular Age-related Macular Degeneration

Treatments

Drug: Aflibercept
Drug: CLS-AX

Study type

Interventional

Funder types

Industry

Identifiers

NCT05891548
CLS1002-202

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

60 participants in 2 patient groups

1.0 mg CLS-AX
Experimental group
Description:
Suprachoroidal injection of 10 mg/mL (1.0 mg in 0.1 mL) of CLS-AX
Treatment:
Drug: CLS-AX
Aflibercept
Active Comparator group
Description:
Intravitreal injection of aflibercept (2 mg in 0.05 mL)
Treatment:
Drug: Aflibercept

Trial contacts and locations

32

Loading...

Central trial contact

Donna Bezner, M.S.

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems