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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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, followed by visits every two months until study completion. |
|
| 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, followed by visits every two months until study completion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
A. Prior Ocular Treatment Study Eye
Either Eye
B. Choroidal Neovascularization (CNV) Lesion Characteristics
Study Eye
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
Fellow (Non-Study) Eye
• Non-functioning fellow eye
Either Eye
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: YR42983 https://forpatients.roche.com/ No attachments to email below. | Contact | 888-662-6728 (U.S. and Canada) | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | 100032 | China | ||
| Beijing Hospital |
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| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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| 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. Afterwards, participants will receive IVT ranibizumab injections of 50 μL of the 10 mg/mL formulation Q4W at each scheduled study visit until Week 44 and bi-monthly visits thereafter, followed by visits every two months until study completion. |
|
| 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 |
| Proportion of Participants Who Gain ≥ 0 Letters in BCVA Score From Baseline Averaged Over Weeks 36 and 40 | Baseline up to Week 40 |
| Proportion of Participants Who Gain ≥ 0 Letters in BCVA Score From Baseline Averaged Over Weeks 44 and 48 | 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 | 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 | 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). | Baseline and 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. | Baseline and 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. | Baseline and 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. | Baseline and 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 | Baseline up to 144 weeks |
| Proportion of Participants in the Implant Arm Who do not Undergo a Supplemental Treatment that Requires Subsequent Additional Supplemental Treatments During the Study | Baseline up to 144 weeks |
| Percentage of Participants With Adverse Events (AEs) | Baseline up to 144 weeks |
| Percentage of Participants With Adverse Events of Special Interest (AESIs) | Baseline up to 144 weeks |
| Duration of AESIs | Baseline up to 144 weeks |
| Percentage of Participants With Ocular AESIs During the Post-operative Period and Follow-up Period | Post-operative period: up to 37 days after initial implantation Follow-up period: > 37 days after implantation surgery (up to 144 weeks) |
| Percentage of Participants Who Received PDS Affected With Adverse Device Effects (ADEs) | Baseline up to 144 weeks |
| Percentage of Participants Who Received PDS Affected With Anticipated Serious Adverse Device Effects (ASADEs) | Baseline up to 144 weeks |
| Duration of ASADEs | Baseline up to 144 weeks |
| Number of Device Deficiencies | Baseline up to 144 weeks |
| Observed Serum Ranibizumab Concentrations at Specified Timepoints | Implant Arm: Weeks 4, 12, 24, 28, 36, 48, 96, 144 and early study termination (EST) visit; IVT Arm: Weeks 4, 24, 36, 48, 52, 60, 72, 76, 84, 96, 144 & EST visit (up to 156 weeks) |
| Area Under the Concentration Time Curve (AUC) From 0-24 Weeks | Baseline, Weeks 4, 12, and 24 |
| Maximum Serum Concentration (Cmax) of Ranibizumab | Implant Arm: Weeks 4, 12, 24, 28, 36, 48, 96, 144 & EST visit; IVT Arm: Weeks 52, 60, 72, 76, 84, 96, 144, & EST visit (up to 156 weeks) |
| Minimum Serum Concentration (Cmin) of Ranibizumab | Implant Arm: Weeks 4, 12, 24, 28, 36, 48, 96, 144, & EST visit; IVT Arm: Weeks 52, 60, 72, 76, 84, 96, 144, & EST visit (up to 156 weeks) |
| Number of Participants With Anti-drug Antibodies (ADAs) to Ranibizumab | Implant Arm: Baseline; Weeks 4, 24, 36, 48, 96, 144 & EST visit; IVT Arm: Baseline, Weeks 4, 24, 36, 48, 52, 72, 96, 144 & EST visit (up to 156 weeks) |
| Number of Participants With Treatment-emergent ADAs to Ranibizumab During the Study | Implant Arm: Weeks 4, 24, 36, 48, 96, 144, & EST visit; IVT Arm: Weeks 4, 24, 36, 48, 52, 72, 96, 144, & EST visit (up to 156 weeks) |
| Withdrawn |
| Beijing |
| 100730 |
| China |
| Beijing Tongren Hospital | Recruiting | Beijing | 100730 | China |
| West China Hospital, Sichuan University | Recruiting | Chengdu | 610041 | China |
| Sichuan Provincial People's Hospital | Recruiting | Chengdu | 610072 | China |
| Zhongshan Ophthalmic Center, Sun Yat-sen University | Recruiting | Guangzhou | 510060 | China |
| The Second Affiliated Hospital of Harbin Medical University | Recruiting | Harbin | 150081 | China |
| Qingdao Eye Hospital of Shandong First Medical University | Recruiting | Qingdao | 266109 | China |
| Shanghai First People's Hospital | Recruiting | Shanghai | 200080 | China |
| Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Withdrawn | Shanghai | 200092 | China |
| The First Affiliated Hospital of China Medical University | Recruiting | Shenyang | 110001 | China |
| Shanxi Eye Hospital | Recruiting | Taiyuan | 030002 | China |
| Tianjin Medical University Eye Hospital | Recruiting | Tianjin | 300070 | China |
| Eye Hospital, Wenzhou Medical University | Recruiting | Wenzhou | 325027 | China |
| Tongji Hospital Tongji Medical College Huazhong University of Science and Technology | Recruiting | Wuhan | 430030 | China |
| Xi'an People's Hospital (Xi'an Fourth Hospital) | Recruiting | Xi'an | China |
| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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