A Study Of The Efficacy, Safety, And Pharmacokinetics Of The Port Delivery System With Ranibizumab In Chinese Patients With Neovascular Age-Related Macular Degeneration

• Status: Recruiting
• Trial end date: 2027-02-28
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy, safety, and pharmacokinetics of ranibizumab 100 mg/mL delivered Q24W via the PDS implant compared with ranibizumab 0.5 mg delivered as a Q4W intravitreal injection in Chinese patients with nAMD.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Ranibizumab

Criteria

Inclusion Criteria:

• Initial diagnosis of nAMD within 9 months prior to the screening visit

• Previous treatment with at least three anti-VEGF intravitreal injections for nAMD per standard of care within 6 months prior to the screening visit

• Demonstrated response to prior anti-VEGF intravitreal treatment since diagnosis

• Availability of historical VA data prior to the first anti-VEGF treatment for nAMD up to the screening visit

• BCVA of 34 letters or better (20/200 or better approximate Snellen equivalent), using Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters

• All subtypes of nAMD lesions are permissible

• Sufficiently clear ocular media and adequate pupillary dilation to allow for analysis and grading by the central reading center of FP, FA, ICGA, FAF, and OCT images

Exclusion Criteria:

Study Eye

• History of vitrectomy surgery, submacular surgery, or other surgical intervention, all for AMD

• Prior treatment with Visudyne, external-beam radiation therapy, or transpupillary thermotherapy

• Previous treatment with corticosteroid intravitreal injection

• Previous intraocular device implantation (not including intraocular lens implants)

• Previous laser (any type) used for AMD treatment

• Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to the randomization visit

• Concurrent conjunctival, Tenon's capsule, and/or scleral condition in the supero temporal quadrant of the eye that may affect the implantation, subsequent tissue coverage, and refill-exchange procedure of the PDS implant

• Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is greater than 0.5 disc area (1.27 mm2) in size at screening

• Subfoveal fibrosis or subfoveal atrophy

• Retinal pigment epithelial tear

• Any concurrent intraocular condition

• Active intraocular inflammation (grade trace or above)

• History of vitreous hemorrhage

• History of rhegmatogenous retinal detachment

• History of rhegmatogenous retinal tears or peripheral retinal breaks within 3 months prior to the randomization visit

• History of pars plana vitrectomy surgery

• Aphakia or absence of the posterior capsule

• Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia

• Preoperative refractive error that exceeds 8 diopters of myopia, for patients who have undergone prior refractive or cataract surgery

• Intraocular surgery (including cataract surgery) within 3 months preceding the randomization visit

• Uncontrolled ocular hypertension or glaucoma

• History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery

• History of corneal transplant

Fellow (Non-Study) Eye

• Non-functioning fellow eye

Either Eye

• Prior treatment with brolucizumab (at any time prior to the screening visit)

• Prior participation in a clinical trial involving anti-VEGF drugs within 6 months prior to the randomization visit

• Choroidal neovascularization due to other causes, such as ocular histoplasmosis, trauma, central serous chorio-retinopathy, or pathologic myopia

• Any history of uveitis

• Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis