Status and phase
Conditions
Treatments
About
This study will assess corneal endothelial cells in participants with nAMD treated with PDS refilled every 24 weeks (Q24W).
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria
Ocular Inclusion Criteria:
Initial diagnosis of nAMD within 18 months prior to screening
Difference of <10% in ECD at screening between the 2 eyes as measured by specular microscopy and determined by the independent reading center
Availability of historical visual acuity (VA) data and spectral-domain optical coherence tomography (SD-OCT) imaging prior to the first anti-vascular endothelial growth factor (VEGF) intravitreal therapy (IVT) treatment for nAMD
Availability of comprehensive historical anti-VEGF injection data including anti-VEGF agent administered and date of administration from the first anti-VEGF treatment for nAMD
Demonstrated response to at least two anti-VEGF IVT injections since diagnosis, as evidenced by the following:
Best-corrected visual acuity (BCVA) of 34 letters (approximate 20/200 Snellen equivalent) or better, using Early Treatment of Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters at screening and enrollment
All subtypes of nAMD lesions are permissible
nAMD lesions at the time of diagnosis must involve the macula (6 millimetres (mm) diameter centered at the fovea)
Sufficiently clear ocular media and adequate pupillary dilation to allow for clinical examination and analysis and grading by the central reading center of SD-OCT images
Exclusion Criteria
Prior Ocular Treatment
Study Eye:
Either Eye:
Macular Neovascularization Lesion (MNV) Characteristics
Study Eye:
Concurrent Ocular Conditions
Study Eye:
Fellow (Non-Study) Eye:
• Concurrent PDS implantation
Either Eye:
Concurrent Systemic Conditions:
Primary purpose
Allocation
Interventional model
Masking
188 participants in 1 patient group
Loading...
Central trial contact
Reference Study ID Number: ML43000 https://forpatients.roche.com/
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal