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

  • Neovascular Age-related Macular Degeneration
Trial Status:

Not yet recruiting

This trial runs in
Countries
  • China
Trial Identifier:

NCT05562947 YR42983

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      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.

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT05562947 , YR42983 Trial Identifier
      PDS with ranibizumab (100 mg/mL), Ranibizumab (10 mg/mL) Treatments
      Neovascular Age Related Macular Degeneration, nAMD Condition
      Official Title

      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

      All Gender
      ≥50 Years & ≤ 80 Years Age
      No Healthy Volunteers
      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

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