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

NCT ID: NCT03683251

Last Updated: 2026-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-20

Study Completion Date

2029-10-31

Brief Summary

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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.

Detailed Description

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The Transscleral Photocoagulation sub-study (sub-study 1) will evaluate the effectiveness of using transscleral photocoagulation (TPC) with the Iridex laser system to mitigate vitreous hemorrhages secondary to the Port Delivery System with ranibizumab (PDS) implantation procedure in participants with neovascular age-related macular degeneration (nAMD). The sub-study will enroll about 55 participants.

The Re-implantation sub-study (sub-study 2) will evaluate the safety of re-implantation with the updated PDS with ranibizumab . Up to 100 participants who previously participated in the main study in the United States will be enrolled and followed for a maximum of 72 weeks post-re-implantation in the substudy.

Conditions

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Neovascular Age-Related Macular Degeneration

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The sub-study 1 and sub-study 2 are open-label studies.

Study Groups

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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.

Group Type EXPERIMENTAL

PDS Implant with Ranibizumab 100 mg/mL

Intervention Type DRUG

Will be administered as per the schedule described in individual arm

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.

Group Type EXPERIMENTAL

PDS Implant with Ranibizumab 100 mg/mL

Intervention Type DRUG

Will be administered as per the schedule described in individual arm

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.

Group Type EXPERIMENTAL

PDS Implant with Ranibizumab 100 mg/mL

Intervention Type DRUG

Will be administered as per the schedule described in individual arm

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.

Group Type EXPERIMENTAL

PDS Implant with Ranibizumab 100 mg/mL

Intervention Type DRUG

Will be administered as per the schedule described in individual arm

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.

Group Type EXPERIMENTAL

PDS Implant with Ranibizumab 100 mg/mL

Intervention Type DRUG

Will be administered as per the schedule described in individual arm

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.

Group Type EXPERIMENTAL

PDS Implant with Ranibizumab 100 mg/mL

Intervention Type DRUG

Will be administered as per the schedule described in individual arm

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.

Group Type EXPERIMENTAL

PDS Implant with Ranibizumab 100 mg/mL

Intervention Type DRUG

Will be administered as per the schedule described in individual arm

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.

Group Type EXPERIMENTAL

PDS Implant with Ranibizumab 100 mg/mL

Intervention Type DRUG

Will be administered as per the schedule described in individual arm

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.

Group Type EXPERIMENTAL

PDS Implant with Ranibizumab 100 mg/mL

Intervention Type DRUG

Will be administered as per the schedule described in individual arm

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.

Group Type EXPERIMENTAL

PDS Implant with Ranibizumab 100 mg/mL

Intervention Type DRUG

Will be administered as per the schedule described in individual arm

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.

Group Type EXPERIMENTAL

PDS Implant with Ranibizumab 100 mg/mL

Intervention Type DRUG

Will be administered as per the schedule described in individual arm

Interventions

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PDS Implant with Ranibizumab 100 mg/mL

Will be administered as per the schedule described in individual arm

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.


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

Exclusion Criteria

* Pregnant or breastfeeding, or intending to become pregnant during the treatment period and for at least 28 days after the last intravitreal injection of ranibizumab or 1 year after the last Implant refill-exchange of ranibizumab
* History of other ocular diseases that give reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab, that might affect interpretation of the results of the study or that renders the participant at high risk for treatment complications
* History of other diseases, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the Implant and that might affect interpretation of the results of the study or that renders the participant at high risk of treatment complications
* Requirement for continuous use of any medications or treatments indicated in the "Prohibited Therapy"

Sub-study 1


* History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
* Prior treatment with Visudyne, external-beam radiation therapy, or transpupillary thermotherapy
* Previous treatment with corticosteroid ITV injection
* Previous intraocular device implantation
* Previous laser (any type) used for AMD treatment

Either Eye

* Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to the enrollment visit
* Prior participation in a clinical trial involving anti-VEGF drugs within 6 months prior to the enrollment visit, other than ranibizumab

CNV Lesion Charateristics Study Eye

* Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is greater than 0.5 disc area (1.27 mm2 ) in size at screening
* Subfoveal fibrosis or subfoveal atrophy

Either Eye

\- CNV due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia

Concurrent Ocular Conditions Study Eye

* Retinal pigment epithelial tear
* Any concurrent intraocular condition (e.g., cataract, glaucoma, diabetic retinopathy, or epiretinal membrane) that would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of study results
* Active intraocular inflammation (grade trace or above)
* History of vitreous hemorrhage
* History of rhegmatogenous retinal detachment
* History of rhegmatogenous retinal tears or peripheral retinal breaks within 3 months prior to the enrollment visit
* Aphakia or absence of the posterior capsule
* Previous violation of the posterior capsule is also an exclusion criterion unless it occurred as a result of yttrium-aluminum garnet (YAG) laser posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation.
* Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia
* Preoperative refractive error that exceeds 8 diopters of myopia, for participants who have undergone prior refractive or cataract surgery in the study eye
* Intraocular surgery (including cataract surgery) within 3 months preceding the enrollment visit
* Uncontrolled ocular hypertension or glaucoma and any such condition the investigator determines may require a glaucoma-filtering surgery during a patient's participation in the study
* History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery
* History of corneal transplant
* History of prior vitrectomy surgery and absence of posterior capsule

Either Eye

* History of idiopathic or autoimmune-associated uveitis
* Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis

Concurrent Systemic Conditions

* Inability to comply with study schedule or procedures as described in the study protocol
* Uncontrolled blood pressure
* History of stroke within the last 3 months prior to informed consent
* Uncontrolled atrial fibrillation within 3 months of informed consent
* History of myocardial infarction within the last 3 months prior to informed consent
* History of other disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the implant and that might affect interpretation of the results of the study or renders the patient at high risk of treatment complications in the opinion of the investigator
* Current systemic treatment for a confirmed active systemic infection
* Use of any systemic anti-VEGF agents
* Chronic use of oral corticosteroids
* Active cancer within 12 months of enrollment
* Previous participation in any non-ocular (systemic) disease studies of investigational drugs within 1 month preceding the informed consent (excluding vitamins and minerals)
* Use of antimitotic or antimetabolite therapy within 30 days or 5 elimination half-lives of the enrollment visit
* History of albinism
* Pregnant or breastfeeding, or intending to become pregnant during the treatment period and for at least 28 days after the last ITV injection of ranibizumab or 1 year after the last implant refill-exchange of ranibizumab

Sub-study 2


Concurrent Ocular Conditions-Study Eye

* Any ocular condition that may render the patient at high risk for surgical or treatment complications
* Intraocular surgery (including cataract surgery) within 1 month preceding the enrollment visit
* Any use of medicated intraocular implants (other than the PDS implant), at any time prior to enrollment
* History of rhegmatogenous retinal tears or peripheral retinal breaks within 3 months prior to the enrollment visit
* Any concurrent ocular condition that would require surgical intervention during the study to prevent or treat visual loss
* Concurrent conjunctival, Tenon's capsule, and/or scleral condition in the supero-temporal quadrant of the eye (e.g., scarring, thinning, mass) that may affect the refill-exchange procedure of the PDS implant
* Ongoing ocular complications that might affect participant safety

Concurrent Ocular Conditions-Either Eye

* Suspected or active ocular or periocular infection
* Any history of uveitis
* Active blepharitis

Concurrent Systemic Conditions

* Recent history (in the last 3 months prior to enrollment) of other disease, other non-diabetic metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a condition that contraindicates the use of ranibizumab or surgical placement of the PDS implant; that might affect interpretation of the results of the study; or that renders the participant at high risk for treatment complications
* Active cancer within the last 12 months, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or prostate cancer
* Current systemic treatment for a confirmed active systemic infection - Participation in an investigational trial that involves treatment with any drug or device (with the exception of vitamins and minerals or enrollment in the main study GR40549) within 6 months prior to enrollment.
* Use of antimitotic or antimetabolite therapy within 30 days or 5 elimination half-lives.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Retinal Research Institute, LLC

Phoenix, Arizona, United States

Site Status COMPLETED

Arizona Retina and Vitreous Consultants

Phoenix, Arizona, United States

Site Status COMPLETED

Barnet Dulaney Perkins Eye Center

Phoenix, Arizona, United States

Site Status ACTIVE_NOT_RECRUITING

Associated Retina Consultants

Phoenix, Arizona, United States

Site Status ACTIVE_NOT_RECRUITING

Retinal Consultants of Arizona

Phoenix, Arizona, United States

Site Status COMPLETED

California Retina Consultants

Bakersfield, California, United States

Site Status COMPLETED

Retina-Vitreous Associates Medical Group

Beverly Hills, California, United States

Site Status COMPLETED

The Retina Partners

Encino, California, United States

Site Status ACTIVE_NOT_RECRUITING

Jacobs Retina center at the Shiley eye Institute UCSD

La Jolla, California, United States

Site Status COMPLETED

Jules Stein Eye Institute/ UCLA

Los Angeles, California, United States

Site Status COMPLETED

N CA Retina Vitreous Assoc

Mountain View, California, United States

Site Status COMPLETED

Retina Consultants, San Diego

Poway, California, United States

Site Status COMPLETED

Retinal Consultants Med Group

Sacramento, California, United States

Site Status COMPLETED

West Coast Retina Medical Group

San Francisco, California, United States

Site Status COMPLETED

UCSF

San Francisco, California, United States

Site Status COMPLETED

Orange County Retina Med Group

Santa Ana, California, United States

Site Status COMPLETED

California Retina Consultants

Santa Barbara, California, United States

Site Status COMPLETED

Southwest Retina Consultants

Durango, Colorado, United States

Site Status COMPLETED

Eye Center of Northern CO

Fort Collins, Colorado, United States

Site Status COMPLETED

Colorado Retina Associates, PC

Lakewood, Colorado, United States

Site Status COMPLETED

Retina Group of New England

Waterford, Connecticut, United States

Site Status COMPLETED

Florida Eye Microsurgical Inst

Boynton Beach, Florida, United States

Site Status COMPLETED

National Ophthalmic Research Institute

Fort Myers, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Florida Eye Associates

Melbourne, Florida, United States

Site Status COMPLETED

Retina Care Specialists

Palm Beach Gardens, Florida, United States

Site Status COMPLETED

Retina Specialty Institute

Pensacola, Florida, United States

Site Status COMPLETED

Fort Lauderdale Eye Institute

Plantation, Florida, United States

Site Status COMPLETED

Retina Vitreous Assoc of FL

St. Petersburg, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Southern Vitreoretinal Assoc

Tallahassee, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Retina Associates of Florida, LLC

Tampa, Florida, United States

Site Status COMPLETED

Southeast Retina Center

Augusta, Georgia, United States

Site Status ACTIVE_NOT_RECRUITING

Georgia Retina PC

Marietta, Georgia, United States

Site Status COMPLETED

Illinois Retina Associates

Joliet, Illinois, United States

Site Status COMPLETED

University Retina and Macula Associates, PC

Oak Forest, Illinois, United States

Site Status ACTIVE_NOT_RECRUITING

Wolfe Eye Clinic

West Des Moines, Iowa, United States

Site Status COMPLETED

Retina Associates

Lenexa, Kansas, United States

Site Status COMPLETED

Retina Associates of Kentucky

Lexington, Kentucky, United States

Site Status COMPLETED

Paducah Retinal Center

Paducah, Kentucky, United States

Site Status WITHDRAWN

Maine Eye Center

Portland, Maine, United States

Site Status COMPLETED

The Retina Care Center

Baltimore, Maryland, United States

Site Status ACTIVE_NOT_RECRUITING

Johns Hopkins Med

Baltimore, Maryland, United States

Site Status COMPLETED

Retina Group of Washington

Chevy Chase, Maryland, United States

Site Status ACTIVE_NOT_RECRUITING

Retina Specialists

Towson, Maryland, United States

Site Status ACTIVE_NOT_RECRUITING

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

Site Status COMPLETED

Foundation for Vision Research

Grand Rapids, Michigan, United States

Site Status ACTIVE_NOT_RECRUITING

Associated Retinal Consultants

Royal Oak, Michigan, United States

Site Status COMPLETED

VitreoRetinal Surgery, PLLC.

Minneapolis, Minnesota, United States

Site Status COMPLETED

Midwest Vision Research Foundation

Chesterfield, Missouri, United States

Site Status COMPLETED

The Retina Institute - Chesterfield

St Louis, Missouri, United States

Site Status ACTIVE_NOT_RECRUITING

Sierra Eye Associates

Reno, Nevada, United States

Site Status COMPLETED

Envision Ocular, LLC

Bloomfield, New Jersey, United States

Site Status COMPLETED

Retina Associates of NJ

Teaneck, New Jersey, United States

Site Status COMPLETED

University of New Mexico

Albuquerque, New Mexico, United States

Site Status COMPLETED

Long Is. Vitreoretinal Consult

Great Neck, New York, United States

Site Status COMPLETED

Retina Assoc of Western NY

Rochester, New York, United States

Site Status COMPLETED

Ophthalmic Consultants of Long Island

Rockville Centre, New York, United States

Site Status COMPLETED

Retina Vit Surgeons/Central NY

Syracuse, New York, United States

Site Status COMPLETED

Char Eye Ear &Throat Assoc

Charlotte, North Carolina, United States

Site Status COMPLETED

Cincinnati Eye Institute

Cincinnati, Ohio, United States

Site Status COMPLETED

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status COMPLETED

OSU Eye Physicians & Surgeons

Columbus, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Retina Vitreous Center

Edmond, Oklahoma, United States

Site Status COMPLETED

Retina Northwest

Portland, Oregon, United States

Site Status COMPLETED

Oregon HSU

Portland, Oregon, United States

Site Status COMPLETED

Mid Atlantic Retina - Wills Eye Hospital

Philadelphia, Pennsylvania, United States

Site Status ACTIVE_NOT_RECRUITING

Palmetto Retina Center

Florence, South Carolina, United States

Site Status COMPLETED

Palmetto Retina Center, LLC

West Columbia, South Carolina, United States

Site Status COMPLETED

Charles Retina Institute

Germantown, Tennessee, United States

Site Status COMPLETED

Tennessee Retina PC

Nashville, Tennessee, United States

Site Status ACTIVE_NOT_RECRUITING

Texas Retina Associates

Arlington, Texas, United States

Site Status COMPLETED

Austin Retina Associates

Austin, Texas, United States

Site Status COMPLETED

Austin Clinical Research LLC

Austin, Texas, United States

Site Status WITHDRAWN

Retina Consultants of Texas

Bellaire, Texas, United States

Site Status COMPLETED

Texas Retina Associates

Fort Worth, Texas, United States

Site Status COMPLETED

Med Center Ophthalmology Assoc

San Antonio, Texas, United States

Site Status COMPLETED

Retina Consultants of Texas

The Woodlands, Texas, United States

Site Status ACTIVE_NOT_RECRUITING

Retina Associates of Utah, PLLC

Salt Lake City, Utah, United States

Site Status COMPLETED

Rocky Mountain Retina

Salt Lake City, Utah, United States

Site Status COMPLETED

Wagner Kapoor Institute

Virginia Beach, Virginia, United States

Site Status COMPLETED

Pacific Northwest Retina

Silverdale, Washington, United States

Site Status COMPLETED

Spokane Eye Clinical Research

Spokane, Washington, United States

Site Status COMPLETED

Oftalmos

Capital Federal, , Argentina

Site Status RECRUITING

Centro Oftalmologico Dr. Charles S.A.

Ciudad Autonoma Buenos Aires, , Argentina

Site Status RECRUITING

Grupo Laser Vision

Rosario, , Argentina

Site Status RECRUITING

Eyeclinic Albury Wodonga

Albury, New South Wales, Australia

Site Status RECRUITING

Eye and Retina Consultants

Hurstville, New South Wales, Australia

Site Status RECRUITING

LKH-Univ.Klinikum Graz

Graz, , Austria

Site Status RECRUITING

Medizinische Universitat Wien

Vienna, , Austria

Site Status RECRUITING

UZ Leuven Gasthuisberg

Leuven, , Belgium

Site Status WITHDRAWN

Botelho Hospital da Visao

Blumenau, Santa Catarina, Brazil

Site Status RECRUITING

Retina Clinic

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Universidade Federal de Sao Paulo - UNIFESPX

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Instituto da Visao IPEPO

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Hosp de Olhos de Sorocaba

Sorocaba, São Paulo, Brazil

Site Status RECRUITING

Centre Retine Gallien

Bordeaux, , France

Site Status RECRUITING

Hopital de la croix rousse

Lyon, , France

Site Status RECRUITING

Centre Paradis Monticelli

Marseille, , France

Site Status RECRUITING

Hopital Lariboisiere

Paris, , France

Site Status RECRUITING

Fondation Rothschild

Paris, , France

Site Status RECRUITING

Universitatsklinikum Bonn

Bonn, , Germany

Site Status RECRUITING

Universitatsklinikum Koln

Cologne, , Germany

Site Status RECRUITING

Medizinische Universitat Lausitz ? Carl Thiem

Cottbus, , Germany

Site Status RECRUITING

Universitätsklinikum Freiburg, Klinik für Augenheilkunde

Freiburg im Breisgau, , Germany

Site Status RECRUITING

Universitatsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Site Status RECRUITING

Klinikum der Stadt Ludwigshafen am Rhein gGmbH

Ludwigshafen, , Germany

Site Status RECRUITING

LMU Klinikum der Universitat, Augenklinik

München, , Germany

Site Status RECRUITING

Augenabteilung am St. Franziskus-Hospital

Münster, , Germany

Site Status RECRUITING

Universitatsklinikum Munster

Münster, , Germany

Site Status RECRUITING

Knappschaftsklinikum Saar GmbH

Sulzbach, , Germany

Site Status RECRUITING

Universitatsklinikum Tubingen

Tübingen, , Germany

Site Status RECRUITING

Universitatsklinikum Ulm, Augenklinik und Poliklinik

Ulm, , Germany

Site Status RECRUITING

Rambam Medical Center

Haifa, , Israel

Site Status RECRUITING

Hadassah MC

Jerusalem, , Israel

Site Status RECRUITING

Meir Medical Center

Kfar Saba, , Israel

Site Status RECRUITING

Rabin MC

Petah Tikva, , Israel

Site Status RECRUITING

Kaplan Medical Center

Rehovot, , Israel

Site Status RECRUITING

Tel Aviv Sourasky MC

Tel Aviv, , Israel

Site Status RECRUITING

Ospedale Clinicizzato SS Annunziata

Chieti, Abruzzo, Italy

Site Status RECRUITING

Policlinico di Bari

Bari, Apulia, Italy

Site Status RECRUITING

Azienda Ospedaliero Universitaria "Ospedali Riuniti" Trieste-Ospedale Maggiore

Trieste, Friuli Venezia Giulia, Italy

Site Status RECRUITING

Policlinico Universitario Agostino Gemelli

Rome, Lazio, Italy

Site Status RECRUITING

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

Rome, Lazio, Italy

Site Status RECRUITING

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

Milan, Lombardy, Italy

Site Status RECRUITING

Irccs Ospedale San Raffaele

Milan, Lombardy, Italy

Site Status RECRUITING

Asst Fatebenefratelli Sacco

Milan, Lombardy, Italy

Site Status RECRUITING

Azienda Ospedaliero Universitaria Ospedali Riuniti

Torrette - Ancona, The Marches, Italy

Site Status RECRUITING

Azienda Ospedaliero-Universitaria Careggi

Florence, Tuscany, Italy

Site Status RECRUITING

Azienda Ospedaliera di Perugia Ospedale S. Maria Della Misericordia

Perugia, Umbria, Italy

Site Status RECRUITING

Ospedale Classificato Equiparato Sacro Cuore ? Don Calabria

Negrar - Verona, Veneto, Italy

Site Status RECRUITING

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

Udine, Veneto, Italy

Site Status RECRUITING

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status RECRUITING

Hospital General de Catalunya

San Cugat Del Valles, Barcelona, Spain

Site Status RECRUITING

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain

Site Status RECRUITING

Clinica Universitaria de Navarra

Pamplona, Navarre, Spain

Site Status RECRUITING

Instituto Oftalmologico Fernandez Vega

Oviedo, Principality of Asturias, Spain

Site Status RECRUITING

Oftalvist Valencia

Burjassot, Valencia, Spain

Site Status RECRUITING

Centro de Oftalmologia Barraquer

Barcelona, , Spain

Site Status RECRUITING

Institut de la Macula i la retina

Barcelona, , Spain

Site Status RECRUITING

Hospital dos de maig

Barcelona, , Spain

Site Status COMPLETED

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status RECRUITING

Hospital de la Arruzafa. Servicio de Oftalmologia

Córdoba, , Spain

Site Status RECRUITING

Clinica Baviera

Madrid, , Spain

Site Status RECRUITING

Universitatsspital Basel Augenklinik Klinik

Basel, , Switzerland

Site Status RECRUITING

Inselspital Bern Ophthalmologische Klinik

Bern, , Switzerland

Site Status RECRUITING

Vista Klinik Ophthalmologische Klinik

Binningen, , Switzerland

Site Status ACTIVE_NOT_RECRUITING

Fondation Asile Des Aveugles ? Jules Gonin Eye Hospital

Lausanne, , Switzerland

Site Status RECRUITING

Stadtspital Triemli Ophthalmologische Klinik

Zurich, , Switzerland

Site Status ACTIVE_NOT_RECRUITING

Changhua Christian Hospital

Changhua, , Taiwan

Site Status RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Site Status RECRUITING

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status RECRUITING

Chang Gung Medical Foundation - Linkou

Taoyuan District, , Taiwan

Site Status RECRUITING

National Taiwan University Hospital

Zhongzheng Dist., , Taiwan

Site Status RECRUITING

Hacettepe University Medical Faculty

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Ankara Bilkent City Hospital

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Ankara Etlik City Hospital

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Beyoglu Goz Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Kocaeli University Medical Faculty

Kocaeli, , Turkey (Türkiye)

Site Status RECRUITING

Bristol Eye Hospital

Bristol, , United Kingdom

Site Status RECRUITING

Royal Liverpool University Hospital

Liverpool, , United Kingdom

Site Status ACTIVE_NOT_RECRUITING

Moorfields Eye Hospital NHS Foundation Trust

London, , United Kingdom

Site Status ACTIVE_NOT_RECRUITING

Central Middlesex Hospital

London, , United Kingdom

Site Status RECRUITING

Kings College Hospital NHS Foundation Trust

London, , United Kingdom

Site Status ACTIVE_NOT_RECRUITING

Royal Victoria Infirmary

Newcastle upon Tyne, , United Kingdom

Site Status RECRUITING

Sunderland Eye Infirmary

Sunderland, , United Kingdom

Site Status RECRUITING

Royal Wolverhampton hospital

Wolverhampton, , United Kingdom

Site Status RECRUITING

Countries

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United States Argentina Australia Austria Belgium Brazil France Germany Israel Italy Spain Switzerland Taiwan Turkey (Türkiye) United Kingdom

Central Contacts

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Reference Study ID Number: GR40549 https://forpatients.roche.com/

Role: CONTACT

888-662-6728 (U.S. and Canada)

References

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Eichenbaum DA, Freeman WR, Chang MA, Brooks L, Chaudhry N, Dadgostar H, McCannel CA, Michels M, Mittra RA, Wolfe JD, Beindl VC, Jaycock P, Bobbala A, Gune S, Spicer G, Callaway N. Endophthalmitis in Eyes Treated with the Port Delivery System with Ranibizumab: Summary of Cases during Clinical Trial Development. Ophthalmol Retina. 2025 Feb;9(2):127-143. doi: 10.1016/j.oret.2024.08.005. Epub 2024 Aug 16.

Reference Type DERIVED
PMID: 39154860 (View on PubMed)

Other Identifiers

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2020-004427-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023-507131-38-00

Identifier Type: CTIS

Identifier Source: secondary_id

GR40549

Identifier Type: -

Identifier Source: org_study_id

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