A Study Of The Efficacy, Safety, And Pharmacokinetics Of The Port Delivery System With Ranibizumab In Chinese Patients With Neovascular Age-Related Macular Degeneration
- Eye Disorder
- Neovascular Age-related Macular Degeneration
Recruiting
- bei-jing-shi
- Beijing
- Cheng Du Shi
- guang-zhou-shi
- Harbin
- Qingdao
- shang-hai-shi
- tian-jin-shi
- wen-zhou-shi
NCT05562947 YR42983
Trial 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.
A Phase III, Multicenter, Randomized, Visual Assessor-Masked, Active Comparator Study Of The Efficacy, Safety, And Pharmacokinetics Of The Port Delivery System With Ranibizumab In Chinese Patients With Neovascular Age-Related Macular Degeneration
Eligibility 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
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
For the latest version of this information please go to www.forpatients.roche.com