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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-516924-32-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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The purpose of this study is to evaluate the effectiveness, safety, and PROs of the port delivery system with ranibizumab 100 milligrams/milliliters (mg/mL) refilled every 36 weeks (Q36W) in participants with nAMD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Port Delivery System (PDS) | Experimental | Participants will have the PDS implant (pre-filled with 100 mg/mL of ranibizumab) [approximately 2-milligrams (mg) dose] surgically inserted in the study eye on Day 1. Participants who meet the disease activity criteria (DAC) at Week 24 or receive supplemental treatment with intravitreal (IVT) injections of ranibizumab prior to Week 24 will receive implant refill exchanges every 24 weeks (Q24W). Participants who do not meet the DAC at Week 24 and have not received supplemental treatment will receive PDS refill exchanges Q36W. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Susvimo PDS Implant | Device | Ranizumab will be administered via a PDS implant per the schedule described in the arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity (BCVA) Score Averaged Over Weeks 68 and 72, as Assessed Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at a Starting Distance of 4 Meters | BCVA letters were measured using EDTRS chart while participants were at a starting distance of 4 meter. The range of EDTRS is 0 to 100 letters. Higher scores indicate improvement in visual acuity (VA). | Baseline, Week 68, Week 72 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in BCVA Score Over Time | BCVA letters were measured using EDTRS chart while participants were at a starting distance of 4 meter. The range of EDTRS is 0 to 100 letters. Higher scores indicate improvement in VA. | From baseline up to Week 72 |
| Percentage of Participants Who Lose ≤ 15, ≤ 10, ≤ 5, or Gain ≥ 0 Letters in BCVA Score From Baseline Over Time |
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Inclusion Criteria:
Exclusion Criteria:
A. Prior Ocular Treatment
Study Eye:
Either Eye:
B. Macular Neovascularization/Choroidal Neovascularization (MNV/CNV) Lesion Characteristics:
Study Eye:
Either Eye:
C. Concurrent Ocular Conditions:
Study Eye:
Fellow (Non-study) Eye:
- Non-functioning non-study eye defined as either: BCVA of hand motion or worse OR no physical presence of non-study eye (i.e., monocular)
Either Eye:
D. Concurrent Systemic Conditions:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: MR45625 https://forpatients.roche.com/ No attachments to email below. | Contact | 888-662-6728 (U.S.) | 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 |
|---|---|---|---|---|---|---|
| Medizinische Universität Innsbruck | Recruiting | Innsbruck | 6020 | Austria | ||
| Kepler Universitätskliniken GmbH - Med Campus III |
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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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This is a Phase 3b study.
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The outcome assessor (Visual acuity assessor) will be blinded.
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| Ranibizumab | Drug | Participants will receive ranibizumab delivered through the PDS implant. Participants will receive ranibizumab, 0.5 mg IVT injections as a supplemental treatment. |
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BCVA letters were measured using EDTRS chart while participants were at a starting distance of 4 meter. The range of EDTRS is 0 to 100 letters. Higher scores indicate improvement in VA. |
| From baseline up to Week 72 |
| Change From Baseline in Center Point Thickness (CPT) | From baseline up to Week 72 |
| Change From Baseline in Central Subfield Thickness (CST) | From baseline up to Week 72 |
| Proportion of Participants Who do not Undergo Supplemental Treatment With IVT Ranibizumab Before Each Refill-exchange Procedure | Up to Week 72 |
| Number of Supplemental Treatments Participants Received in Each Refill Cycle | Up to Week 72 |
| Frequency of Study Visits in Each Refill Cycle | Up to Week 72 |
| Proportion of Participants Who Report Preferring PDS Compared With IVT Ranibizumab Treatment as Measured by the PDS Patient Preference Questionnaire (PPPQ) at Weeks 24 and 72 | Weeks 24 and 72 |
| Proportion of Participants With Bilateral Disease Who Report Preferring PDS Compared With IVT Ranibizumab Treatment Measured by the PPPQ at Weeks 24 and 72 | Weeks 24 and 72 |
| Number of Participants With Ocular and Systemic (Non-ocular) Adverse Events (AEs) | Up to approximately 19 months |
| Number of Participants With Adverse Events of Special Interests (AESIs) and their Severity, Including Ocular AESIs | Up to approximately 19 months |
| Number of Participants With Ocular AESIs and Severity of Ocular AESIs During the Post-operative and Follow-up Period | Post-operative period: ≤ 37 days of initial implantation surgery Follow-up period: > 37 days after implantation surgery (up to 72 weeks) |
| Number of Participants With Adverse Device Effects (ADEs) and Severity of ADEs With PDS | Up to approximately 19 months |
| Number of Participants With Anticipated Serious Adverse Device Effects (ASADEs) and Severity of ASADEs With PDS | Up to approximately 19 months |
| Recruiting |
| Linz |
| 4021 |
| Austria |
| Landesklinikum Mistelbach | Recruiting | Mistelbach | 2130 | Austria |
| Klaudianova Nemocnice - Mlada Boleslav;Ophtalmology dpt | Recruiting | Mladá Boleslav | 293 50 | Czechia |
| Faculty Hospital Ostrava | Recruiting | Ostrava | 708 52 | Czechia |
| Ustredni vojenska nemocnice | Recruiting | Prague | 169 02 | Czechia |
| Aarhus Universitetshospital | Recruiting | Aarhus N | 8200 | Denmark |
| Rigshospitalet Glostrup | Recruiting | Glostrup Municipality | 2600 | Denmark |
| Institut Ophtalmologique De l Ouest Jules Verne | Recruiting | Nantes | Paris | 44300 | France |
| Hopital Edouard Herriot - CHU Lyon | Recruiting | Lyon | 69003 | France |
| Clinique Honore Cave | Recruiting | Montauban | 82000 | France |
| CHNO des Quinze Vingts | Recruiting | Paris | 75012 | France |
| CHU Poitiers - CHR La Miletrie | Recruiting | Poitiers | 86021 | France |
| CHU Strasbourg - Nouvel Hopital Civil | Recruiting | Strasbourg | 67091 | France |
| Klinikum Chemnitz gGmbH | Recruiting | Chemnitz | 09116 | Germany |
| Universitätkslinikum Düsseldorf, Augenklinik | Recruiting | Düsseldorf | 40225 | Germany |
| Universitätsmedizin Göttingen Georg-August-Universität | Recruiting | Göttingen | 37075 | Germany |
| Medizinische Hochschule Hannover, Klinik für Augenheilkunde | Recruiting | Hanover | 30625 | Germany |
| Universitätsmedizin Rostock | Recruiting | Rostock | 18057 | Germany |
| Universitätsklinikum Würzburg, Augenklinik und Poliklinik | Recruiting | Würzburg | 97080 | Germany |
| "G.Gennimatas" General Hospital of Athens | Recruiting | Athens | Attica | 115 27 | Greece |
| Attikon University General Hospital | Recruiting | Chaïdári | 124 62 | Greece |
| University General Hospital of Heraklion | Recruiting | Heraklon | 711 10 | Greece |
| University Hospital of Larissa | Recruiting | Larissa | 412 21 | Greece |
| Ospedale Monaldi - AORN dei Colli | Recruiting | Naples | Campania | 80131 | Italy |
| Azienda Ospedaliero - Universitaria di Ferrara - Arcispedale Sant'Anna, Sede Ospedale di Cona;UO di Clinica Oculistica | Recruiting | Cona (Ferrara) | Emilia-Romagna | 44122 | Italy |
| Ospedale Isola Tiberina - Gemelli Isola;UOC Chirurgia Vitreoretinica | Recruiting | Rome | Lazio | 00186 | Italy |
| ASST SANTI PAOLO E CARLO - Presidio San Paolo;SC Oculistica | Recruiting | Milan | Lombardy | 20142 | Italy |
| Azienda Ospedaliero-Universitaria Ospedale Maggiore della Carità;S.C.D.U. Oftalmologia | Recruiting | Novara | Piedmont | 28100 | Italy |
| A.O.U. Policlinico Paolo Giaccone;Oculistica | Recruiting | Palermo | Sicily | 90142 | Italy |
| MW-med | Recruiting | Krakow | Lesser Poland Voivodeship | 31 416 | Poland |
| Szpital sw. Lukasza | Recruiting | Bielsko-Biala | 43-309 | Poland |
| Specjalistyczny O?rodek Okulistyczny Oculomedica | Recruiting | Bydgoszcz | 85-316 | Poland |
| OFTALMIKA Sp. z o.o | Recruiting | Bydgoszcz | 85-631 | Poland |
| Niepubliczny Zak?ad Opieki Zdrowotnej PRYZMAT-OKULISTYKA | Recruiting | Gliwice | 44-100 | Poland |
| Klinika Okulistyczna Jasne Błonia Sp. z o. o. | Recruiting | Lódz | 91-134 | Poland |
| Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie;Klinika Chirurgii Siatkówki i Cia?a Szklistego | Recruiting | Lublin | 20-079 | Poland |
| Centrum Diagnostyki i Mikrochirurgii Oka LENS | Recruiting | Olsztyn | 10-424 | Poland |
| Kyungpook National University Hospital | Recruiting | Daegu | 41944 | South Korea |
| Ajou University Medical Center | Recruiting | Gyeonggi-do | 16499 | South Korea |
| Korea University Anam Hospital | Recruiting | Seoul | 02841 | South Korea |
| Severance Hospital, Yonsei University Health System | Recruiting | Seoul | 03722 | South Korea |
| Seoul St Mary's Hospital | Recruiting | Seoul | 06591 | South Korea |
| Boramae Medical Center | Recruiting | Seoul | 07061 | South Korea |
| Hallym University Kangnam Sacred Heart Hospital | Recruiting | Seoul | 07441 | South Korea |
| Hospital Universitario La Paz | Recruiting | Madrid | 28046 | Spain |
| Hospital Universitario Virgen del Rocio | Recruiting | Seville | 41013 | Spain |
| Hospital Arnau de Vilanova (Valencia) | Recruiting | Valencia | 46015 | Spain |
| Berner Augenklinik | Recruiting | Bern | 3007 | Switzerland |
| Pallas Klinik Olten | Recruiting | Olten | 4600 | Switzerland |
| Kantonsspital St. Gallen | Recruiting | Sankt Gallen | 9007 | Switzerland |
| King Chulalongkorn Memorial Hospital | Recruiting | Bangkok | 10330 | Thailand |
| Rajavithi Hospital | Recruiting | Bangkok | 10400 | Thailand |
| Ramathibodi Hospital | Recruiting | Bangkok | 10400 | Thailand |
| Maharaj Nakorn ChiangMai Hospital | Recruiting | Chiang Mai | 50200 | Thailand |
| Songklanagarind Hospital | Recruiting | Songkhla | 90110 | Thailand |
| Leicester Royal Infirmary | Recruiting | Leicester | Leicestershire | LE1 5WW | United Kingdom |
| Gloucestershire Royal Hospital | Recruiting | Gloucester | GL1 3NN | United Kingdom |
| Moorfields Eye Hospital NHS Foundation Trust | Recruiting | London | EC1V 2PD | United Kingdom |
| 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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