A Study of the Efficacy, Safety, and Pharmacokinetics of A 36-Week Refill Regimen for the Port Delivery System with Ranibizumab in Patients with Wet Age-Related Macular Degeneration (Velodrome)
- Conditions
- eovascular age-related macular degeneration (nAMD)Therapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- CTIS2023-507130-24-00
- Lead Sponsor
- F. Hoffmann-La Roche AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 442
Ocular inclusion criteria: Initial diagnosis nAMD within 9 months prior to the screening visit, Ocular inclusion criteria: Previous treatment with at least three anti- vascular endothelial growth factor (VEGF) intravitreal injections for nAMD per standard of care within 6 months prior to the screening visit, Ocular inclusion criteria: Availability of historical visual acuity data prior to the first anti-VEGF treatment for nAMD until the time of study enrollment, Ocular inclusion criteria: BCVA of 34 letters or better, using Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters at screening and enrollment visits, Ocular inclusion criteria: With any subtype of nAMD lesions -nAMD lesions at the time of diagnosis must involve the macula (6-mm diameter centered at the fovea), Ocular inclusion criteria: Sufficiently clear ocular media and adequate pupillary dilation to allow for analysis and grading by the central reading center of fundus photography, fluorescein angiography, fundus autofluorescence image, and OCT images
Prior Ocular Treatment: Study Eye History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD, Prior Ocular Treatment: Either Eye Prior participation in a clinical trial involving any therapies for nAMD, within 9 months from the time of nAMD diagnosis, CNV Lesion Characteristics: Study Eye Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is greater than 0.5 disc area in size at screening, Concurrent Systemic Conditions: Uncontrolled blood pressure, Concurrent Systemic Conditions: Use of any systemic anti-VEGF agents, Concurrent Systemic Conditions: Use of antimitotic or antimetabolite therapy within 30 days or 5 elimination half-lives of the enrollment visit
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method