ClinicalTrialsFinder

RecruitingPhase 3NCT03683251

Extension Study for the Port Delivery System With Ranibizumab (Portal)

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)

Sponsor

Hoffmann-La Roche

Enrollment

1,000 participants

Start Date

Sep 20, 2018

Study Type

INTERVENTIONAL

Conditions

Neovascular Age-related Macular Degeneration

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

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called PDS Implant with Ranibizumab 100 mg/mL for people with neovascular age-related macular degeneration. The study is currently recruiting participants at 165 locations. People eligible for this study include aged 50 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGPDS Implant with Ranibizumab 100 mg/mL

Will be administered as per the schedule described in individual arm

Locations(165)

Retinal Research Institute, LLC

Phoenix, Arizona, United States

Arizona Retina and Vitreous Consultants

Phoenix, Arizona, United States

Barnet Dulaney Perkins Eye Center

Phoenix, Arizona, United States

Associated Retina Consultants

Phoenix, Arizona, United States

Retinal Consultants of Arizona

Phoenix, Arizona, United States

California Retina Consultants

Bakersfield, California, United States

Retina-Vitreous Associates Medical Group

Beverly Hills, California, United States

The Retina Partners

Encino, California, United States

Jacobs Retina center at the Shiley eye Institute UCSD

La Jolla, California, United States

Jules Stein Eye Institute/ UCLA

Los Angeles, California, United States

N CA Retina Vitreous Assoc

Mountain View, California, United States

Retina Consultants, San Diego

Poway, California, United States

Retinal Consultants Med Group

Sacramento, California, United States

West Coast Retina Medical Group

San Francisco, California, United States

UCSF

San Francisco, California, United States

Orange County Retina Med Group

Santa Ana, California, United States

California Retina Consultants

Santa Barbara, California, United States

Southwest Retina Consultants

Durango, Colorado, United States

Eye Center of Northern CO

Fort Collins, Colorado, United States

Colorado Retina Associates, PC

Lakewood, Colorado, United States

Retina Group of New England

Waterford, Connecticut, United States

Florida Eye Microsurgical Inst

Boynton Beach, Florida, United States

National Ophthalmic Research Institute

Fort Myers, Florida, United States

Florida Eye Associates

Melbourne, Florida, United States

Retina Care Specialists

Palm Beach Gardens, Florida, United States

Retina Specialty Institute

Pensacola, Florida, United States

Fort Lauderdale Eye Institute

Plantation, Florida, United States

Retina Vitreous Assoc of FL

St. Petersburg, Florida, United States

Southern Vitreoretinal Assoc

Tallahassee, Florida, United States

Retina Associates of Florida, LLC

Tampa, Florida, United States

Southeast Retina Center

Augusta, Georgia, United States

Georgia Retina PC

Marietta, Georgia, United States

Illinois Retina Associates

Joliet, Illinois, United States

University Retina and Macula Associates, PC

Oak Forest, Illinois, United States

Wolfe Eye Clinic

West Des Moines, Iowa, United States

Retina Associates

Lenexa, Kansas, United States

Retina Associates of Kentucky

Lexington, Kentucky, United States

Paducah Retinal Center

Paducah, Kentucky, United States

Maine Eye Center

Portland, Maine, United States

The Retina Care Center

Baltimore, Maryland, United States

Johns Hopkins Med

Baltimore, Maryland, United States

Retina Group of Washington

Chevy Chase, Maryland, United States

Retina Specialists

Towson, Maryland, United States

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

Foundation for Vision Research

Grand Rapids, Michigan, United States

Associated Retinal Consultants

Royal Oak, Michigan, United States

VitreoRetinal Surgery, PLLC.

Minneapolis, Minnesota, United States

Midwest Vision Research Foundation

Chesterfield, Missouri, United States

The Retina Institute - Chesterfield

St Louis, Missouri, United States

Sierra Eye Associates

Reno, Nevada, United States

Envision Ocular, LLC

Bloomfield, New Jersey, United States

Retina Associates of NJ

Teaneck, New Jersey, United States

University of New Mexico

Albuquerque, New Mexico, United States

Long Is. Vitreoretinal Consult

Great Neck, New York, United States

Retina Assoc of Western NY

Rochester, New York, United States

Ophthalmic Consultants of Long Island

Rockville Centre, New York, United States

Retina Vit Surgeons/Central NY

Syracuse, New York, United States

Char Eye Ear &Throat Assoc

Charlotte, North Carolina, United States

Cincinnati Eye Institute

Cincinnati, Ohio, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

OSU Eye Physicians & Surgeons

Columbus, Ohio, United States

Retina Vitreous Center

Edmond, Oklahoma, United States

Retina Northwest

Portland, Oregon, United States

Oregon HSU

Portland, Oregon, United States

Mid Atlantic Retina - Wills Eye Hospital

Philadelphia, Pennsylvania, United States

Palmetto Retina Center

Florence, South Carolina, United States

Palmetto Retina Center, LLC

West Columbia, South Carolina, United States

Charles Retina Institute

Germantown, Tennessee, United States

Tennessee Retina PC

Nashville, Tennessee, United States

Texas Retina Associates

Arlington, Texas, United States

Austin Retina Associates

Austin, Texas, United States

Austin Clinical Research LLC

Austin, Texas, United States

Retina Consultants of Texas

Bellaire, Texas, United States

Texas Retina Associates

Fort Worth, Texas, United States

Med Center Ophthalmology Assoc

San Antonio, Texas, United States

Retina Consultants of Texas

The Woodlands, Texas, United States

Retina Associates of Utah, PLLC

Salt Lake City, Utah, United States

Rocky Mountain Retina

Salt Lake City, Utah, United States

Wagner Kapoor Institute

Virginia Beach, Virginia, United States

Pacific Northwest Retina

Silverdale, Washington, United States

Spokane Eye Clinical Research

Spokane, Washington, United States

Oftalmos

Capital Federal, Argentina

Centro Oftalmologico Dr. Charles S.A.

Ciudad Autonoma Buenos Aires, Argentina

Grupo Laser Vision

Rosario, Argentina

Eyeclinic Albury Wodonga

Albury, New South Wales, Australia

Eye and Retina Consultants

Hurstville, New South Wales, Australia

LKH-Univ.Klinikum Graz

Graz, Austria

Medizinische Universitat Wien

Vienna, Austria

UZ Leuven Gasthuisberg

Leuven, Belgium

Botelho Hospital da Visao

Blumenau, Santa Catarina, Brazil

Retina Clinic

São Paulo, São Paulo, Brazil

Universidade Federal de Sao Paulo - UNIFESPX

São Paulo, São Paulo, Brazil

Instituto da Visao IPEPO

São Paulo, São Paulo, Brazil

Hosp de Olhos de Sorocaba

Sorocaba, São Paulo, Brazil

Centre Retine Gallien

Bordeaux, France

Hopital de la croix rousse

Lyon, France

Centre Paradis Monticelli

Marseille, France

Hopital Lariboisiere

Paris, France

Fondation Rothschild

Paris, France

Universitatsklinikum Bonn

Bonn, Germany

Universitatsklinikum Koln

Cologne, Germany

Medizinische Universitat Lausitz ? Carl Thiem

Cottbus, Germany

Universitätsklinikum Freiburg, Klinik für Augenheilkunde

Freiburg im Breisgau, Germany

Universitatsklinikum Hamburg-Eppendorf

Hamburg, Germany

Klinikum der Stadt Ludwigshafen am Rhein gGmbH

Ludwigshafen, Germany

LMU Klinikum der Universitat, Augenklinik

München, Germany

Augenabteilung am St. Franziskus-Hospital

Münster, Germany

Universitatsklinikum Munster

Münster, Germany

Knappschaftsklinikum Saar GmbH

Sulzbach, Germany

Universitatsklinikum Tubingen

Tübingen, Germany

Universitatsklinikum Ulm, Augenklinik und Poliklinik

Ulm, Germany

Rambam Medical Center

Haifa, Israel

Hadassah MC

Jerusalem, Israel

Meir Medical Center

Kfar Saba, Israel

Rabin MC

Petah Tikva, Israel

Kaplan Medical Center

Rehovot, Israel

Tel Aviv Sourasky MC

Tel Aviv, Israel

Ospedale Clinicizzato SS Annunziata

Chieti, Abruzzo, Italy

Policlinico di Bari

Bari, Apulia, Italy

Azienda Ospedaliero Universitaria "Ospedali Riuniti" Trieste-Ospedale Maggiore

Trieste, Friuli Venezia Giulia, Italy

Policlinico Universitario Agostino Gemelli

Rome, Lazio, Italy

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

Rome, Lazio, Italy

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

Milan, Lombardy, Italy

Irccs Ospedale San Raffaele

Milan, Lombardy, Italy

Asst Fatebenefratelli Sacco

Milan, Lombardy, Italy

Azienda Ospedaliero Universitaria Ospedali Riuniti

Torrette - Ancona, The Marches, Italy

Azienda Ospedaliero-Universitaria Careggi

Florence, Tuscany, Italy

Azienda Ospedaliera di Perugia Ospedale S. Maria Della Misericordia

Perugia, Umbria, Italy

Ospedale Classificato Equiparato Sacro Cuore ? Don Calabria

Negrar - Verona, Veneto, Italy

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

Udine, Veneto, Italy

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital General de Catalunya

San Cugat Del Valles, Barcelona, Spain

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain

Clinica Universitaria de Navarra

Pamplona, Navarre, Spain

Instituto Oftalmologico Fernandez Vega

Oviedo, Principality of Asturias, Spain

Oftalvist Valencia

Burjassot, Valencia, Spain

Centro de Oftalmologia Barraquer

Barcelona, Spain

Institut de la Macula i la retina

Barcelona, Spain

Hospital dos de maig

Barcelona, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital de la Arruzafa. Servicio de Oftalmologia

Córdoba, Spain

Clinica Baviera

Madrid, Spain

Universitatsspital Basel Augenklinik Klinik

Basel, Switzerland

Inselspital Bern Ophthalmologische Klinik

Bern, Switzerland

Vista Klinik Ophthalmologische Klinik

Binningen, Switzerland

Fondation Asile Des Aveugles ? Jules Gonin Eye Hospital

Lausanne, Switzerland

Stadtspital Triemli Ophthalmologische Klinik

Zurich, Switzerland

Changhua Christian Hospital

Changhua, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Chang Gung Medical Foundation - Linkou

Taoyuan, Taiwan

National Taiwan University Hospital

Zhongzheng Dist., Taiwan

Hacettepe University Medical Faculty

Ankara, Turkey (Türkiye)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Ankara Etlik City Hospital

Ankara, Turkey (Türkiye)

Beyoglu Goz Training and Research Hospital

Istanbul, Turkey (Türkiye)

Kocaeli University Medical Faculty

Kocaeli, Turkey (Türkiye)

Bristol Eye Hospital

Bristol, United Kingdom

Royal Liverpool University Hospital

Liverpool, United Kingdom

Moorfields Eye Hospital NHS Foundation Trust

London, United Kingdom

Central Middlesex Hospital

London, United Kingdom

Kings College Hospital NHS Foundation Trust

London, United Kingdom

Royal Victoria Infirmary

Newcastle upon Tyne, United Kingdom

Sunderland Eye Infirmary

Sunderland, United Kingdom

Royal Wolverhampton hospital

Wolverhampton, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

NCT03683251

Related Trials

A Study Assessing Corneal Endothelial Cells in Participants With Neovascular Age-related Macular Degeneration (nAMD) Treated With the Port Delivery System With Ranibizumab (PDS)

NCT0485325151 locations

A Study to Evaluate Efficacy, Safety, and Immunogenicity With ABP 938 8 mg Versus EYLEA® HD (Aflibercept) in Participants With Neovascular Age-related Macular Degeneration

NCT0761477618 locations

A Real-World Study to Gain Clinical Insights Into Faricimab (FaReal Study)

NCT0668081759 locations

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)

NCT0556294716 locations

Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD)

NCT07007065128 locations