Age-Related Macular Degeneration (ARMD) Clinical Trials

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A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration (Portal)

Who is this study for? Patients with Neovascular Age-Related Macular Degeneration
What treatments are being studied? PDS Implant+Ranibizumab
Status: Recruiting
Location: See all (156) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This study will evaluate the long-term safety and tolerability of the Port Delivery System with ranibizumab (PDS) (100 mg/mL) in participants with neovascular age-related macular degeneration (nAMD) who have either completed Phase II Study GX28228 (Ladder), Phase III Study GR40548 (Archway), Phase IIIb Study WR42221 (Velodrome), or completed Week 24 visit in Study WR42221 but were not eligible to be randomized in WR42221.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• Previous enrollment in and completion of Study GX28228 (Ladder) or Study GR40548 (Archway), without early treatment or study discontinuation in either study OR Previous enrollment in Study WR42221 (Velodrome) and either not eligible to be randomized in Study WR42221 at Week 24 or completed the study (from the Q24W or Q36W arm)

• Ability and willingness to undertake all scheduled visits and assessments

• For women of childbearing potential: agreement to remain abstinent or use contraceptive measures

⁃ \- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures

⁃ Participants must meet the following ocular criteria for the study eye for substudy entry:

• Diagnosis of exudative nAMD within 2 years prior to the enrollment visit

• Previous treatment with at least two anti-VEGF ITV injections (e.g., ranibizumab, bevacizumab, or aflibercept) for nAMD per standard of care within 6 months prior to the enrollment visit

• Demonstrated response to prior anti-VEGF ITV treatment since diagnosis, as evidenced at enrollment by the following:

⁃ Overall decrease in nAMD disease activity detected on SD-OCT AND Stable or improved best-corrected visual acuity (BCVA)

• All subtypes of nAMD lesions are permissible (i.e., type I, type II, type III, or mixed forms per optical coherence tomography (OCT) classification) nAMD lesions at the time of diagnosis must involve the macula (6 mm diameter centered at the fovea).

• Sufficiently clear ocular media and adequate pupillary dilation to allow for analysis and grading by the central reading center of FP and SD-OCT images.

• Having experienced septum dislodgement in the original implant while in the main study or after exiting the main study Ocular Inclusion Criteria for Study Eye

• Sufficiently clear ocular media and adequate pupillary dilation to allow for analysis and grading by central reading center

Locations
United States
Arizona
Arizona Retina and Vitreous Consultants
COMPLETED
Phoenix
Associated Retina Consultants
ACTIVE_NOT_RECRUITING
Phoenix
Barnet Dulaney Perkins Eye Center
ACTIVE_NOT_RECRUITING
Phoenix
Retinal Consultants of Arizona
COMPLETED
Phoenix
Retinal Research Institute, LLC
COMPLETED
Phoenix
California
California Retina Consultants
COMPLETED
Bakersfield
Retina-Vitreous Associates Medical Group
COMPLETED
Beverly Hills
The Retina Partners
ACTIVE_NOT_RECRUITING
Encino
Jacobs Retina center at the Shiley eye Institute UCSD
COMPLETED
La Jolla
Jules Stein Eye Institute/ UCLA
COMPLETED
Los Angeles
N CA Retina Vitreous Assoc
COMPLETED
Mountain View
Retina Consultants, San Diego
COMPLETED
Poway
Retinal Consultants Med Group
ACTIVE_NOT_RECRUITING
Sacramento
UCSF
ACTIVE_NOT_RECRUITING
San Francisco
West Coast Retina Medical Group
COMPLETED
San Francisco
Orange County Retina Med Group
ACTIVE_NOT_RECRUITING
Santa Ana
California Retina Consultants
COMPLETED
Santa Barbara
Colorado
Southwest Retina Consultants
COMPLETED
Durango
Eye Center of Northern CO
ACTIVE_NOT_RECRUITING
Fort Collins
Colorado Retina Associates, PC
COMPLETED
Lakewood
Connecticut
Retina Group of New England
ACTIVE_NOT_RECRUITING
Waterford
Florida
Florida Eye Microsurgical Inst
COMPLETED
Boynton Beach
National Ophthalmic Research Institute
ACTIVE_NOT_RECRUITING
Fort Myers
Florida Eye Associates
COMPLETED
Melbourne
Retina Care Specialists
COMPLETED
Palm Beach Gardens
Retina Specialty Institute
ACTIVE_NOT_RECRUITING
Pensacola
Fort Lauderdale Eye Institute
COMPLETED
Plantation
Retina Vitreous Assoc of FL
ACTIVE_NOT_RECRUITING
St. Petersburg
Southern Vitreoretinal Assoc
ACTIVE_NOT_RECRUITING
Tallahassee
Retina Associates of Florida, LLC
ACTIVE_NOT_RECRUITING
Tampa
Georgia
Southeast Retina Center
ACTIVE_NOT_RECRUITING
Augusta
Georgia Retina PC
ACTIVE_NOT_RECRUITING
Marietta
Iowa
Wolfe Eye Clinic
ACTIVE_NOT_RECRUITING
West Des Moines
Illinois
Illinois Retina Associates
ACTIVE_NOT_RECRUITING
Joliet
University Retina and Macula Associates, PC
ACTIVE_NOT_RECRUITING
Oak Forest
Kansas
Retina Associates
ACTIVE_NOT_RECRUITING
Lenexa
Kentucky
Retina Associates of Kentucky
ACTIVE_NOT_RECRUITING
Lexington
Paducah Retinal Center
WITHDRAWN
Paducah
Massachusetts
Ophthalmic Consultants of Boston
COMPLETED
Boston
Maryland
Johns Hopkins Med
ACTIVE_NOT_RECRUITING
Baltimore
The Retina Care Center
ACTIVE_NOT_RECRUITING
Baltimore
Retina Group of Washington
ACTIVE_NOT_RECRUITING
Chevy Chase
Retina Specialists
ACTIVE_NOT_RECRUITING
Towson
Maine
Maine Eye Center
ACTIVE_NOT_RECRUITING
Portland
Michigan
Foundation for Vision Research
ACTIVE_NOT_RECRUITING
Grand Rapids
Associated Retinal Consultants
ACTIVE_NOT_RECRUITING
Royal Oak
Minnesota
VitreoRetinal Surgery, PLLC.
ACTIVE_NOT_RECRUITING
Minneapolis
Missouri
Midwest Vision Research Foundation
COMPLETED
Chesterfield
The Retina Institute - Chesterfield
ACTIVE_NOT_RECRUITING
St Louis
North Carolina
Char Eye Ear &Throat Assoc
COMPLETED
Charlotte
New Jersey
Envision Ocular, LLC
COMPLETED
Bloomfield
Retina Associates of NJ
ACTIVE_NOT_RECRUITING
Teaneck
New Mexico
University of New Mexico
COMPLETED
Albuquerque
Nevada
Sierra Eye Associates
COMPLETED
Reno
New York
Long Is. Vitreoretinal Consult
COMPLETED
Great Neck
Retina Assoc of Western NY
COMPLETED
Rochester
Ophthalmic Consultants of Long Island
COMPLETED
Rockville Centre
Retina Vit Surgeons/Central NY
COMPLETED
Syracuse
Ohio
Cincinnati Eye Institute
COMPLETED
Cincinnati
The Cleveland Clinic Foundation
ACTIVE_NOT_RECRUITING
Cleveland
OSU Eye Physicians & Surgeons
ACTIVE_NOT_RECRUITING
Columbus
Oklahoma
Retina Vitreous Center
ACTIVE_NOT_RECRUITING
Edmond
Oregon
Oregon HSU
COMPLETED
Portland
Retina Northwest
ACTIVE_NOT_RECRUITING
Portland
Pennsylvania
Mid Atlantic Retina - Wills Eye Hospital
ACTIVE_NOT_RECRUITING
Philadelphia
South Carolina
Palmetto Retina Center
ACTIVE_NOT_RECRUITING
Florence
Palmetto Retina Center, LLC
ACTIVE_NOT_RECRUITING
West Columbia
Tennessee
Charles Retina Institute
ACTIVE_NOT_RECRUITING
Germantown
Tennessee Retina PC
ACTIVE_NOT_RECRUITING
Nashville
Texas
Texas Retina Associates
ACTIVE_NOT_RECRUITING
Arlington
Austin Clinical Research LLC
ACTIVE_NOT_RECRUITING
Austin
Austin Retina Associates
ACTIVE_NOT_RECRUITING
Austin
Retina Consultants of Texas
ACTIVE_NOT_RECRUITING
Bellaire
Texas Retina Associates
COMPLETED
Fort Worth
Med Center Ophthalmology Assoc
ACTIVE_NOT_RECRUITING
San Antonio
Retina Consultants of Texas
ACTIVE_NOT_RECRUITING
The Woodlands
Utah
Retina Associates of Utah, PLLC
ACTIVE_NOT_RECRUITING
Salt Lake City
Rocky Mountain Retina
ACTIVE_NOT_RECRUITING
Salt Lake City
Virginia
Wagner Kapoor Institute
ACTIVE_NOT_RECRUITING
Virginia Beach
Washington
Pacific Northwest Retina
COMPLETED
Silverdale
Spokane Eye Clinical Research
COMPLETED
Spokane
Other Locations
Argentina
Centro Oftalmologico Dr. Charles S.A.
RECRUITING
Capital Federal
Oftalmos
RECRUITING
Capital Federal
Grupo Laser Vision
RECRUITING
Rosario
Australia
Eyeclinic Albury Wodonga
RECRUITING
Albury
Eye and Retina Consultants
RECRUITING
Hurstville
Austria
LKH-Univ.Klinikum Graz
RECRUITING
Graz
Medizinische Universitat Wien
RECRUITING
Vienna
Belgium
UZ Leuven Gasthuisberg
RECRUITING
Leuven
Brazil
Botelho Hospital da Visao
RECRUITING
Blumenau
Instituto da Visao IPEPO
RECRUITING
São Paulo
Retina Clinic
RECRUITING
São Paulo
Universidade Federal de Sao Paulo - UNIFESPX
RECRUITING
São Paulo
France
Centre Retine Gallien
RECRUITING
Bordeaux
Hopital de la croix rousse
RECRUITING
Lyon
Centre Paradis Monticelli
RECRUITING
Marseille
Fondation Rothschild
RECRUITING
Paris
Hopital Lariboisiere
RECRUITING
Paris
Germany
Universitatsklinikum Bonn
RECRUITING
Bonn
Universitatsklinikum Koln
RECRUITING
Cologne
Medizinische Universitat Lausitz ? Carl Thiem
RECRUITING
Cottbus
Universitätsklinikum Freiburg, Klinik für Augenheilkunde
RECRUITING
Freiburg Im Breisgau
Universitatsklinikum Hamburg-Eppendorf
RECRUITING
Hamburg
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
RECRUITING
Ludwigshafen
LMU Klinikum der Universitat, Augenklinik
RECRUITING
München
Augenabteilung am St. Franziskus-Hospital
RECRUITING
Münster
Universitatsklinikum Munster
RECRUITING
Münster
Knappschaftsklinikum Saar GmbH
RECRUITING
Sulzbach
Universitatsklinikum Tubingen
RECRUITING
Tübingen
Universitatsklinikum Ulm, Augenklinik und Poliklinik
RECRUITING
Ulm
Israel
Rambam Medical Center
RECRUITING
Haifa
Hadassah MC
RECRUITING
Jerusalem
Meir Medical Center
RECRUITING
Kfar Saba
Rabin MC
RECRUITING
Petah Tikva
Kaplan Medical Center
RECRUITING
Rehovot
Tel Aviv Sourasky MC
RECRUITING
Tel Aviv
Italy
Policlinico di Bari
RECRUITING
Bari
Ospedale Clinicizzato SS Annunziata
RECRUITING
Chieti
Azienda Ospedaliero-Universitaria Careggi
RECRUITING
Florence
Asst Fatebenefratelli Sacco
RECRUITING
Milan
Ospedale Classificato Equiparato Sacro Cuore ? Don Calabria
RECRUITING
Negrar - Verona
Policlinico Universitario Agostino Gemelli
RECRUITING
Rome
Azienda Ospedaliero Universitaria Ospedali Riuniti
RECRUITING
Torrette - Ancona
A.O. Universitaria S. Maria Della Misericordia Di Udine
RECRUITING
Udine
Spain
Centro de Oftalmologia Barraquer
RECRUITING
Barcelona
Hospital dos de maig
COMPLETED
Barcelona
Institut de la Macula i la retina
RECRUITING
Barcelona
Oftalvist Valencia
ACTIVE_NOT_RECRUITING
Burjassot
Hospital de la Arruzafa. Servicio de Oftalmologia
RECRUITING
Córdoba
Hospital Universitario de Bellvitge
RECRUITING
L'hospitalet De Llobregat
Hospital Universitario Puerta de Hierro
RECRUITING
Majadahonda
Clinica Universitaria de Navarra
RECRUITING
Pamplona
Hospital General de Catalunya
RECRUITING
San Cugat Del Valles
Switzerland
Universitatsspital Basel Augenklinik Klinik
RECRUITING
Basel
Inselspital Bern Ophthalmologische Klinik
RECRUITING
Bern
Vista Klinik Ophthalmologische Klinik
ACTIVE_NOT_RECRUITING
Binningen
Fondation Asile Des Aveugles ? Jules Gonin Eye Hospital
RECRUITING
Lausanne
Stadtspital Triemli Ophthalmologische Klinik
ACTIVE_NOT_RECRUITING
Zurich
Taiwan
Changhua Christian Hospital
RECRUITING
Changhua
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
Taipei Veterans General Hospital
RECRUITING
Taipei
Chang Gung Medical Foundation - Linkou
RECRUITING
Taoyuan District
National Taiwan University Hospital
RECRUITING
Zhongzheng Dist.
Turkey
Ankara Bilkent City Hospital
RECRUITING
Ankara
Ankara Etlik City Hospital
RECRUITING
Ankara
Hacettepe University Medical Faculty
RECRUITING
Ankara
Beyoglu Goz Training and Research Hospital
RECRUITING
Istanbul
Kocaeli University Medical Faculty
RECRUITING
Kocaeli
United Kingdom
Bristol Eye Hospital
RECRUITING
Bristol
Royal Liverpool University Hospital
RECRUITING
Liverpool
Central Middlesex Hospital
RECRUITING
London
Kings College Hospital NHS Foundation Trust
RECRUITING
London
Moorfields Eye Hospital NHS Foundation Trust
ACTIVE_NOT_RECRUITING
London
Royal Victoria Infirmary
RECRUITING
Newcastle Upon Tyne
Sunderland Eye Infirmary
RECRUITING
Sunderland
Royal Wolverhampton hospital
RECRUITING
Wolverhampton
Contact Information
Primary
Reference Study ID Number: GR40549 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. and Canada)
Time Frame
Start Date: 2018-09-20
Estimated Completion Date: 2029-09-30
Participants
Target number of participants: 1000
Treatments
Experimental: PDS Implant Cohort 1 (US only)
Participants with PDS implant from Study GX28228 treated with refill-exchanges of 100 mg/mL ranibizumab Q24W. Participants will switch to an every 12 weeks (Q12W) visit schedule from Week 168 to Week 240.~Eligible participants from Study GX28228 will be enrolled upon completion of their final visit.
Experimental: PDS Implant Cohort 2 (US only)
Participants with PDS implant from Study GR40548 treated with refill-exchanges of 100 mg/mL ranibizumab Q24W. Participants will switch to an every 12 weeks (Q12W) visit schedule from Week 144 to Week 240.~Eligible participants from Study GR40548 will be enrolled upon completion of their final visit.
Experimental: PDS Implant Cohort 3 (US only)
Participants in the intravitreal ranibizumab arm of Study GX28228 who will receive the PDS implant upon study entry and refill-exchanges of 100 mg/mL ranibizumab Q24W. Participants will switch to an every 12 weeks (Q12W) visit schedule from Week 168 to Week 240.~Eligible participants from Study GX28228 will be enrolled upon completion of their final visit.
Experimental: PDS Implant Cohort 4 (US only)
Participants in the intravitreal ranibizumab arm of Study GR40548 who will receive the PDS implant upon study entry and refill-exchanges of 100 mg/mL ranibizumab Q24W. Participants will switch to an every 12 weeks (Q12W) visit schedule from Week 144 to Week 240.~Eligible participants from Study GR40548 will be enrolled upon completion of their final visit.
Experimental: PDS Implant Cohort 5 (ex-US only)
Participants from Study WR42221 who completed Week 24 but were not eligible to be randomized within WR42221 and who will be treated with refill-exchanges of ranibizumab 100 mg/mL Q24W. Participants will be in the study for a minimum of 144 weeks and may continue after Week 144 until the PDS has received Health Authority approval (or non-approval) in their respective country and/or until the decision to close the study has been made by the sponsor.
Experimental: PDS Implant Cohort 6 (ex-US only)
Participants from Study WR42221 randomized to the Q24W arm, who will continue to be treated with refill-exchanges of ranibizumab 100 mg/mL Q24W. Participants will be in the study for a minimum of 144 weeks and may continue after Week 144 until the PDS has received Health Authority approval (or non-approval) in their respective country and/or until the decision to close the study has been made by the sponsor.
Experimental: PDS Implant Cohort 7 (ex-US only)
Participants from Study WR42221 randomized to the Q36W arm, who will continue to be treated with refill-exchanges of ranibizumab 100 mg/mL Q36W. Participants will be in the study for a minimum of 144 weeks and may continue after Week 144 until the PDS has received Health Authority approval (or non-approval) in their respective country and/or until the decision to close the study has been made by the sponsor.
Experimental: Sub-study 1: PDS Implant
Participants will receive PDS implant using TPC on Day 1 followed by refill-exchanges of ranibizumab 100 mg/mL via the PDS Q24W.
Experimental: Sub-study 2: Cohort 1
Participants will undergo re-implantation with the updated PDS implant and receive 2 refill-exchanges of ranibizumab 100 mg/mL Q24W.
Experimental: Sub-study 2: Cohort 2a
Participants who received an updated PDS implant, have \< 24 weeks post-re-implantation follow-up and no refill exchange visit in the main study, will undergo two refill-exchange procedures with ranibizumab 100 mg/mL Q24W post main study re-implantation visit.
Experimental: Sub-study 2: Cohort 2b
Participants who received an updated PDS implant, have \< 48 weeks post-re-implantation follow-up and one refill exchange visit in the main study, will undergo one refill-exchange procedure with ranibizumab 100 mg/mL Q24W post main study re-implantation visit.
Related Therapeutic Areas
Late-Onset Retinal Degeneration
Age-Related Macular Degeneration (ARMD)
Sponsors
Leads: Hoffmann-La Roche

This content was sourced from clinicaltrials.gov

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