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

Keywords

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

Lead sponsor

Clearside Biomedical, Inc. is the lead sponsor of 14 studies on the registry; none are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 7 (88%) have results posted.

Eligibility criteria

Study arms

• Experimental
  1.0 mg CLS-AX

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

  Drug: CLS-AX

• Active comparator
  Aflibercept

  Intravitreal injection of aflibercept (2 mg in 0.05 mL)

  Drug: Aflibercept

Interventions

• DrugCLS-AX

  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

• DrugAflibercept

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

  Also known as: Eylea

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.

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

Secondary outcomes

1. 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.

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

2. 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.

   Time frame: Baseline, Week 36

3. 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.

   Time frame: From Baseline Through Week 36

4. 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.

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

Individual participant data

Plan to share: No