The purpose of this study is to evaluate the effectiveness, safety, and PROs of the port delivery system with ranibizumab 100 milligrams/milliliters (mg/mL) refilled every 36 weeks (Q36W) in participants with nAMD.
Who can participate
Age range50 Years
SexALL
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Inclusion Criteria:
* Initial diagnosis of nAMD within 24 months prior to screening
* Previous treatment with at least 3 anti-vascular endothelial growth factor (VEGF) IVT injections for nAMD per standard of care within 6 months prior to screening
* Demonstrated response to prior anti-VEGF IVT treatment since diagnosis
* Availability of historical VA data obtained at or after nAMD diagnosis and prior to the first anti-VEGF treatment for nAMD
* Availability of historical OCT image data obtained at or after nAMD diagnosis and prior to the first anti-VEGF treatment for nAMD
* BCVA of 34 letters or better using ETDRS chart at a starting distance of 4 meters at screening and enrollment visits
Exclusion Criteria:
A. Prior Ocular Treatment
Study Eye:
* History of vitrectomy surgery, submacular surgery, or other surgical intervention for age-related macular degeneration (AMD)
* Previous treatment with corticosteroid intravitreal injection
* Previous intraocular device implantation
* History of vitreous hemorrhage
* History of rhegmatogenous retinal detachment
* History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery
* History of corneal transplant
Either Eye:
* History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the ranibizumab injections, study-related procedure preparations (including fluorescein), dilating drops, or any of the anesthetic and antimicrobial preparations …
What they're measuring
1
Change From Baseline in Best Corrected Visual Acuity (BCVA) Score Averaged Over Weeks 68 and 72, as Assessed Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at a Starting Distance of 4 Meters
Timeframe: Baseline, Week 68, Week 72
Trial details
NCT IDNCT06847542
SponsorHoffmann-La Roche
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2028-09-12
Contact for this trial
Reference Study ID Number: MR45625 https://forpatients.roche.com/