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)

NCT05562947 | Recruiting Phase 3 DMC FDA Drug FDA Device

• 1 other identifier: YR42983
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 16

Brief Summary

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.

Conditions

Neovascular Age-related Macular Degeneration; nAMD

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline up to Week 40

Secondary Outcomes (27)

• Change From Baseline in BCVA Score Over Time

  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

  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

  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

  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

  Baseline up to Week 48

Study Arms (2)

Implant Arm

EXPERIMENTAL

Participants will have the implant (pre-filled intraoperatively with ranibizumab 100 mg/mL) surgically inserted on Day 1. After Day 1, participants in the implant arm will attend monthly study visits, and receive implant refill-exchanges with ranibizumab 100 mg/mL at Week 24 and Week 48. At the Week 48 study visit, participants will move to the long -term extension phase of the study and continue receiving refill-exchanges Q24W until the end of study. Participants will attend monthly visits up to Week 96 and bi-monthly visits, thereafter.

Device: PDS With Ranibizumab (100 mg/mL)

IVT Arm

EXPERIMENTAL

Participants will receive IVT ranibizumab 0.5 mg injections starting on Day 1. Participants will receive IVT ranibizumab 0.5 mg Q4W until Week 44. At the Week 48 study visit, participants will receive the PDS implant (pre-filled intraoperatively with ranibizumab 100 mg/mL), move to the long-term extension phase of the study and receive Q24W refill exchanges until the end of study. If participants are unable to attend the Week 48 visit due to extenuating circumstances, they should return no later than the next scheduled visit (Week 52), when they will receive the PDS implant. Participants will attend monthly visits up to Week 96 and bi-monthly visits, thereafter.

Drug: Ranibizumab (10 mg/mL)

Interventions

PDS With Ranibizumab (100 mg/mL) DEVICE

Participants randomized to the implant arm will have the implant (filled prior to implantation with approximately 20 microliters (μL) of the 100-mg/mL formulation of ranibizumab \[approximately 2 mg dose of ranibizumab\]) surgically inserted in the study eye at the Day 1 visit following their randomization visit, or at Week 48 visit for participants randomized to the IVT arm. After the initial fill of the implant with ranibizumab, participants will receive implant refill-exchanges at fixed 24-week intervals.

Implant Arm

Ranibizumab (10 mg/mL) DRUG

Participants in the IVT arm will receive their first IVT injection of 50 μL of the 10 mg/mL ranibizumab (0.5 mg dose) at the Day 1 visit, which will occur at the conclusion of the randomization visit. Afterward, participants will receive IVT ranibizumab injections of 50 μL of the 10 mg/mL formulation Q4W at each scheduled study visit until Week 44.

IVT Arm

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (16)

Peking Union Medical College Hospital

Beijing, 100032, China

RECRUITING

Beijing Hospital

Beijing, 100730, China

WITHDRAWN

Beijing Tongren Hospital

Beijing, 100730, China

RECRUITING

West China Hospital, Sichuan University

Chengdu, 610041, China

RECRUITING

Sichuan Provincial People's Hospital

Chengdu, 610072, China

RECRUITING

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, 510060, China

RECRUITING

The Second Affiliated Hospital of Harbin Medical University

Harbin, 150081, China

RECRUITING

Qingdao Eye Hospital of Shandong First Medical University

Qingdao, 266109, China

RECRUITING

Shanghai First People's Hospital

Shanghai, 200080, China

RECRUITING

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, 200092, China

ACTIVE NOT RECRUITING

The First Affiliated Hospital of China Medical University

Shenyang, 110001, China

RECRUITING

Shanxi Eye Hospital

Taiyuan, 030002, China

RECRUITING

Tianjin Medical University Eye Hospital

Tianjin, 300070, China

RECRUITING

Eye Hospital, Wenzhou Medical University

Wenzhou, 325027, China

RECRUITING

Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, 430030, China

RECRUITING

Xi'an People's Hospital (Xi'an Fourth Hospital)

Xi'an, China

RECRUITING

MeSH Terms

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: YR42983, https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S. and Canada); global-roche-genentech-trials@gene.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: October 3, 2022
• Study Start: June 17, 2024
• Primary Completion (Estimated): July 27, 2027
• Study Completion (Estimated): August 30, 2029
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (16)