A Study of the Efficacy, Safety, and Pharmacokinetics of a 36-Week Refill Regimen for the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration (Velodrome)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

451

Participants

Timeline

Start Date

July 14, 2021

Primary Completion Date

January 7, 2027

Study Completion Date

January 7, 2027

Conditions
Neovascular Age-related Macular Degeneration (nAMD)
Interventions
DRUG

Ranibizumab

"Arm A: Participants will receive ranibizumab delivered through the PDS implant with 100 mg/mL in the study eye on Day 1 and receive refill-exchanges at fixed 36-week intervals~Arm B: Participants will receive ranibizumab delivered through the PDS implant with 100 mg/mL in the study eye on Day 1 and receive refill-exchanges at fixed 24-week intervals"

DEVICE

Port Delivery System with Ranibizumab

"Arm A: Participants will receive ranibizumab delivered through the PDS implant with 100 mg/mL in the study eye on Day 1 and receive refill-exchanges at fixed 36-week intervals~Arm B: Participants will receive ranibizumab delivered through the PDS implant with 100 mg/mL in the study eye on Day 1 and receive refill-exchanges at fixed 24-week intervals"

Trial Locations (113)

333

Chang Gung Medical Foundation - Linkou, Taoyuan District

500

Changhua Christian Hospital, Changhua

1090

Medizinische Universität Wien, Vienna

2000

Sydney Eye Hospital, Sydney

Sydney Retina Clinic and Day Surgery, Sydney

2170

Retina Associates Liverpool, Liverpool

2220

Eye and Retina Consultants, Hurstville

2228

Retina and Macula Specialists, Miranda

2640

Eyeclinic Albury Wodonga, Albury

3000

UZ Leuven Gasthuisberg, Leuven

3002

Centre For Eye Research Australia, East Melbourne

3010

Inselspital Bern Ophthalmologische Klinik, Bern

3178

Retina Specialists Victoria, Rowville

4056

Universitätsspital Basel Augenklinik Klinik, Basel

4102

Queensland Eye Institute, Woolloongabba

Vista Klinik Ophthalmologische Klinik, Binningen

6009

The Lions Eye Institute, Nedlands

8036

LKH-Univ.Klinikum Graz, Graz

8063

Stadtspital Triemli Ophthalmologische Klinik, Zurich

10002

National Taiwan University Hospital, Zhongzheng Dist.

10126

AOU Città della Salute e della Scienza di Torino, Turin

11217

Taipei Veterans General Hospital, Taipei

13008

Centre Paradis Monticelli, Marseille

13605

Seoul National University Bundang Hospital, Seongnam-si

14012

Hospital de la Arruzafa. Servicio de Oftalmologia, Córdoba

20100

Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena, Milan

20132

Irccs Ospedale San Raffaele, Milan

20157

Asst Fatebenefratelli Sacco, Milan

20246

Universitätsklinikum Hamburg-Eppendorf, Hamburg

21079

CHU Bocage, Dijon

21565

Gachon University Gil Medical Center, Incheon

28027

Clinica Universitaria de Navarra, Madrid

28046

Clinica Baviera, Madrid

28222

Hospital Universitario Puerta de Hierro, Majadahonda

31008

Clinica Universitaria de Navarra, Pamplona

31059

Hôpital PURPAN - CHU TOULOUSE, Toulouse

33000

Centre Rétine Gallien, Bordeaux

33012

Instituto Oftalmologico Fernandez Vega, Oviedo

33100

A.O. Universitaria S. Maria Della Misericordia Di Udine, Udine

34129

"Azienda Ospedaliero Universitaria Ospedali Riuniti Trieste-Ospedale Maggiore", Trieste

34421

Beyoglu Goz Training and Research Hospital, Istanbul

37024

Ospedale Classificato Equiparato Sacro Cuore ? Don Calabria, Negrar - Verona

41380

Kocaeli Üniversitesi T?p Fakültesi, Kocaeli

42415

Yeungnam University Medical Center, Daegu

44093

CHU Nantes - Hôtel Dieu, Nantes

46004

Oftalvist Valencia, Valencia

48145

Augenabteilung am St. Franziskus-Hospital, Münster

48149

Universitätsklinikum Münster, Münster

49241

Pusan National University Hospital, Busan

50134

Azienda Ospedaliero-Universitaria Careggi, Florence

50937

Universitätsklinikum Köln, Cologne

53127

Universitatsklinikum Bonn, Bonn

60126

Azienda Ospedaliero Universitaria Ospedali Riuniti, Torrette - Ancona

60590

Augenzentrum Prof. Koch GmbH, Frankfurt

66100

Ospedale Clinicizzato SS Annunziata, Chieti

66280

Knappschaftsklinikum Saar GmbH, Sulzbach

67063

Klinikum der Stadt Ludwigshafen am Rhein gGmbH, Ludwigshafen

69317

Hopital de la croix rousse, Lyon

70124

Policlinico di Bari, Bari

72076

Universitätsklinikum Tübingen, Tübingen

75010

Hopital Lariboisiere, Paris

75940

Fondation Rothschild, Paris

79106

Universitätsklinikum Freiburg, Klinik für Augenheilkunde, Freiburg im Breisgau

80336

LMU Klinikum der Universität, Augenklinik, München

89075

Universitätsklinikum Ulm, Augenklinik und Poliklinik, Ulm

119074

National University Hospital, Singapore

168751

Singapore Eye Research Institute, Singapore

308433

Tan Tock Seng Hospital, Singapore

3109601

Rambam Medical Center, Haifa

4428164

Meir Medical Center, Kfar Saba

4941492

Rabin MC, Petah Tikva

6423906

Tel Aviv Sourasky MC, Tel Aviv

7660101

Kaplan Medical Center, Rehovot

9112001

Hadassah MC, Jerusalem

C1116

Centro Oftalmológico Dr. Charles S.A., Capital Federal

C1120AAN

Oftalmos, Capital Federal

S2000DLA

Grupo Laser Vision, Rosario

Unknown

Hospital das Clinicas - UFRGS, Porto Alegre

Fondation Asile Des Aveugles ? Jules Gonin Eye Hospital, Lausanne

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

Ankara Etlik City Hospital, Ankara

89052-504

Botelho Hospital da Visao, Blumenau

01427-002

Retina Clinic, São Paulo

04023-062

Universidade Federal de Sao Paulo - UNIFESP*X, São Paulo

04038-032

Instituto da Visão IPEPO, São Paulo

18031-060

Hosp de Olhos de Sorocaba, Sorocaba

03048

Medizinische Universität Lausitz ? Carl Thiem, Cottbus

00168

Policlinico Universitario Agostino Gemelli, Rome

00198

Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico, Rome

06129

Azienda Ospedaliera di Perugia Ospedale S. Maria Della Misericordia, Perugia

02447

Kyung Hee University Hospital, Seoul

03080

Seoul National University Hospital, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

07301

Kim's Eye Hospital, Seoul

08907

Hospital Universitario de Bellvitge, L'Hospitalet de Llobregat

08195

Hospital General de Catalunya, San Cugat Del Valles

08021

Centro de Oftalmologia Barraquer, Barcelona

08022

Institut de la Macula i la retina, Barcelona

08025

Hospital dos de maig, Barcelona

08028

Hospital Clinic de Barcelona, Barcelona

08035

Hospital Universitari Vall d'Hebron, Barcelona

06100

Hacettepe University Medical Faculty, Ankara

06490

Ankara Bilkent City Hospital, Ankara

BS1 2LX

Bristol Eye Hospital, Bristol

L7 8XP

Royal Liverpool University Hospital, Liverpool

EC1V 2PD

Moorfields Eye Hospital NHS Foundation Trust, London

NW10 7NS

Central Middlesex Hospital, London

SE5 9RS

Kings College Hospital, London

NE1 4LP

Royal Victoria Infirmary, Newcastle upon Tyne

SO16 6YD

University Hospital Southampton NHS Foundation Trust, Southampton

SR2 9HP

Sunderland Eye Infirmary, Sunderland

WV10 0QP

New Cross Hospital, Wolverhampton

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY