A Study of the Efficacy, Safety, and Pharmacokinetics (PK) of the Port Delivery System With Ranibizumab (PDS) in Chinese Participants With Neovascular Age-related Macular Degeneration (nAMD)

Phase 3RecruitingNCT05562947

Hoffmann-La Roche68 enrolled

Overview

This study will evaluate the efficacy, safety, and PK of ranibizumab 100 milligrams per milliliter (mg/mL) delivered every 24 weeks (Q24W) via the PDS implant compared with ranibizumab 0.5 milligrams (mg) delivered every 4 weeks (Q4W) as intravitreal (IVT) injection in chinese participants with nAMD.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Neovascular Age-related Macular Degeneration nAMD

Interventions

PDS With Ranibizumab (100 mg/mL)

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Initial diagnosis of nAMD within 9 months prior to the screening visit * Previous treatment with at least three anti-vascular endothelial growth factor (VEGF) IVT injections for nAMD per standard of care within 6 months prior to the screening visit * Demonstrated response to prior anti-VEGF IVT 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 fundus photography (FP), fluorescein angiography (FA), indocyanine green angiography (ICGA), fundus autofluorescence (FAF), and optical coherence tomography (OCT) images Exclusion Criteria: A. Prior Ocular Treatment 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 IVT injection * Previous intraocular device implantation (not including intraocular lens implants) * Previous laser (any type) used for age-related macular degeneration (AMD) treatment * Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to the randomization visit * Prior treatment with intravitreal treatments for geographic atrophy * 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 Either Eye * Prior treatment with brolucizumab * Prior gene therapy for nAMD or other ocular diseases * Previous participation in any ocular disease studies of investigational drugs and/or devices, within 3 months or five elimination half-lives of the investigational therapy, whichever is longer, preceding the screening visit B. Choroidal Neovascularization (CNV) Lesion Characteristics Study Eye * Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is greater than 0.5 disc area (1.27 millimeter square \[mm\^2\]) in size at screening * Subfoveal fibrosis or subfoveal atrophy Either Eye • CNV due to other causes, such as ocular histoplasmosis, trauma, central serous chorio-retinopathy, or pathologic myopia C. Concurrent Ocular Conditions Study Eye * 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 participants 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 * Any history of uveitis * Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis

Locations (16)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

Beijing Hospital

Beijing, China

WITHDRAWN

Beijing Tongren Hospital

Beijing, China

RECRUITING

West China Hospital, Sichuan University

Chengdu, China

RECRUITING

Sichuan Provincial People's Hospital

Chengdu, China

RECRUITING

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, China

RECRUITING

The Second Affiliated Hospital of Harbin Medical University

Harbin, China

RECRUITING

Qingdao Eye Hospital of Shandong First Medical University

Qingdao, China

RECRUITING

Shanghai First People's Hospital

Shanghai, China

RECRUITING

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China

ACTIVE_NOT_RECRUITING

...and 6 more locations

Outcomes

Primary Outcomes

Change From Baseline in Best-corrected Visual Acuity (BCVA) Score Averaged Over Weeks 36 and 40, as Assessed Using the ETDRS Visual Acuity (VA) Chart at a Starting Distance of 4 Meters

Time frame: Baseline up to Week 40

Secondary Outcomes

Change From Baseline in BCVA Score Over Time

Time frame: Baseline up to Week 144

Proportion of Participants With BCVA Score of 38 Letters (20/200 Approximate Snellen Equivalent) or Worse Averaged Over Weeks 36 and 40

Time frame: Baseline up to Week 40

Proportion of Participants With BCVA Score of 38 Letters (20/200 Approximate Snellen Equivalent) or Worse Averaged Over Weeks 44 and 48

Time frame: Baseline up to Week 48

Proportion of Participants With BCVA Score of 69 Letters (20/40 Approximate Snellen Equivalent) or Better Averaged over Weeks 36 and 40

Time frame: Baseline up to Week 40

Proportion of Participants With BCVA Score of 69 Letters (20/40 Approximate Snellen Equivalent) or Better Averaged Over Weeks 44 and 48

Time frame: Baseline up to Week 48

Proportion of Participants Who Gain ≥0 Letters in BCVA Score From Baseline Averaged Over Weeks 36 and 40

Time frame: Baseline up to Week 40

Proportion of Participants Who Gain ≥ 0 Letters in BCVA Score From Baseline Averaged Over Weeks 44 and 48

Time frame: Baseline up to Week 48

Proportion of Participants Who Lose < 10 or < 5 Letters in BCVA Score From Baseline Averaged Over Weeks 36 and 40

Time frame: Baseline up to Week 40

Proportion of Participants Who Lose < 10 or < 5 Letters in BCVA Score From Baseline Averaged Over Weeks 44 and 48

Time frame: Baseline up to Week 48

Change From Baseline in Center Point Thickness (CPT) at Week 36

CPT is retinal thickness in the center point of the fovea measured between the internal limiting membrane and the inner third of the retinal pigment epithelium layer. CPT will be measured using optical coherence tomography (OCT).

Time frame: Baseline, Week 36

Change From Baseline in Central Subfield Thickness (CST) at Week 36

CST is defined as the average thickness of the central 1 millimeter (mm) circle of the ETDRS grid centered on the fovea. CST will be measured using OCT.

Time frame: Baseline, Week 36

Change From Baseline in CPT at Week 44

CPT is retinal thickness in the center point of the fovea measured between the internal limiting membrane and the inner third of the retinal pigment epithelium layer. CPT will be measured using OCT.

Time frame: Baseline, Week 44

Change From Baseline in CST at Week 44

CST is defined as the average thickness of the central 1 mm circle of the ETDRS grid centered on the fovea. CST will be measured using OCT.

Time frame: Baseline, Week 44

Proportion of Participants in the Implant Arm Who do not Undergo Supplemental Treatment With IVT Ranibizumab 0.5 mg Before the First, Second, Third, Fourth, Fifth, and Sixth Fixed Refill-exchange Intervals