A Phase III Study to Evaluate the Port Delivery System With Ranibizumab Compared With Monthly Ranibizumab Injections in Participants With Wet Age-Related Macular Degeneration
Archway
Phase III, Multicenter, Randomized, Visual Assessor-Masked, Active-Comparator Study of the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration
1 other identifier
interventional
415
1 country
77
Brief Summary
Study GR40548 is a Phase III, randomized, multicenter, open-label (visual assessor \[VA\]-masked), active-comparator study designed to assess the efficacy, safety, and pharmacokinetics (PK) of 100mg/ml delivered via the Port Delivery System with ranibizumab (PDS) compared with ranibizumab intravitreal injections at 0.5 mg (10 mg/mL) in participants with neovascular age-related macular degeneration (nAMD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2018
Typical duration for phase_3
77 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2018
CompletedStudy Start
First participant enrolled
September 12, 2018
CompletedFirst Posted
Study publicly available on registry
September 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 22, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 9, 2021
CompletedResults Posted
Study results publicly available
March 25, 2022
CompletedOctober 4, 2022
September 1, 2022
1.7 years
September 11, 2018
November 18, 2021
September 6, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Best-Corrected Visual Acuity (BCVA) Score at the Average of Week 36 and Week 40, as Assessed Using the ETDRS Visual Acuity Chart at a Starting Distance of 4 Meters
The primary efficacy endpoint is the change in BCVA score from baseline averaged over Weeks 36 and 40 with BCVA assessed using the ETDRS chart at a starting distance of 4 meters. ETDRS = Early Treatment Diabetic Retinopathy Study. The primary objective is to determine the NI and equivalence between the two treatment groups, as measured by the primary efficacy endpoint with a NI margin of 4.5 letters and equivalence margins of ± 4.5 letters. A vision score of 20/20 vision is considered normal. A score of 20/200 is considered being legally blind.
Baseline, and the average of Week 36 and Week 40
Secondary Outcomes (22)
Change From Baseline in BCVA Score Averaged Over Week 60 and Week 64
Baseline, Week60, Week 64
Change From Baseline in BCVA Score Over Time
Baseline up to Week 96
Percentage of Participants With BCVA Score of 38 Letters (20/200 Approximate Snellen Equivalent) or Worse at the Average Over Week 36 and Week 40
Baseline, and the average of Week 36 and Week 40
Percentage of Participants With BCVA Score of 38 Letters (20/200 Approximate Snellen Equivalent) or Worse Over Time
Baseline up to Week 96
Percentage of Participants With BCVA Score of 69 Letters (20/40 Approximate Snellen Equivalent) or Better at the Average Over Week 36 and Week 40
Baseline, and the average of Week 36 and Week 40
- +17 more secondary outcomes
Study Arms (2)
PDS Implant Arm
EXPERIMENTALParticipants 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
Intravitreal Arm
ACTIVE COMPARATORParticipants will receive ranibizumab 0.5 mg monthly intravitreal injections of 10 mg/mL formulation at Day 1 and every month thereafter.
Interventions
Will be administered as per the schedule described in individual arm.
Will be administered as per the schedule described in individual arm.
Eligibility Criteria
You may qualify if:
- Age ≥50 years, at time of signing Informed Consent Form
- Initial diagnosis of exudative neovascular age-related macular degeneration (nAMD) within 9 months prior to the screening visit
- Previous treatment with at least three anti-vascular endothelial growth factor (anti-VEGF) intravitreal injections for nAMD per standard of care within 6 months prior to the screening visit
- Demonstrated response to prior anti-VEGF intravitreal treatment since diagnosis
- Best-corrected visual acuity (BCVA) of 34 letters or better
You may not qualify if:
- Subfoveal fibrosis or subfoveal atrophy in study eye
- Subretinal hemorrhage that involves the center of the fovea in study eye
- History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in study eye
- Prior treatment with Visudyne®, external-beam radiation therapy, or transpupillary thermotherapy in study eye
- Previous intraocular device implantation in study eye
- Previous laser (any type) used for AMD treatment in study eye
- Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to the randomization visit in either eye
- Prior participation in a clinical trial involving anti-VEGF drugs within 6 months prior to the randomization visit, other than ranibizumab in either eye
- CNV due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia in either eye
- 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 participant at high risk of treatment complications in the opinion of the investigator
- Current systemic treatment for a confirmed active systemic infection
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (77)
Barnet Dulaney Perkins Eye Center
Mesa, Arizona, 85206, United States
Associated Retina Consultants
Phoenix, Arizona, 85020, United States
Arizona Retina and Vitreous Consultants
Phoenix, Arizona, 85021, United States
Retinal Consultants of Arizona
Phoenix, Arizona, 85053, United States
California Retina Consultants
Bakersfield, California, 93309, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211, United States
The Retina Partners
Encino, California, 91436, United States
Jules Stein Eye Institute/ UCLA
Los Angeles, California, 90095-7000, United States
N CA Retina Vitreous Assoc
Mountain View, California, 94040, United States
Retina Consultants, San Diego
Poway, California, 92064, United States
Retinal Consultants Med Group
Sacramento, California, 95825, United States
West Coast Retina Medical Group
San Francisco, California, 94109, United States
UCSF; Ophthalmology
San Francisco, California, 94143, United States
Orange County Retina Med Group
Santa Ana, California, 92705, United States
California Retina Consultants
Santa Barbara, California, 93103, United States
Bay Area Retina Associates
Walnut Creek, California, 94598, United States
Southwest Retina Consultants
Durango, Colorado, 81303, United States
Eye Center of Northern CO
Fort Collins, Colorado, 80528, United States
Colorado Retina Associates, PC
Lakewood, Colorado, 80228, United States
Retina Group of New England
Waterford, Connecticut, 06385, United States
National Ophthalmic Research Institute
Fort Myers, Florida, 33912, United States
Florida Eye Associates
Melbourne, Florida, 32901, United States
Retina Care Specialists
Palm Beach Gardens, Florida, 33410, United States
Retina Specialty Institute
Pensacola, Florida, 32503, United States
Fort Lauderdale Eye Institute
Plantation, Florida, 33324, United States
Retina Vitreous Assoc of FL
St. Petersburg, Florida, 33711, United States
Southern Vitreoretinal Assoc
Tallahassee, Florida, 32308, United States
Retina Associates of Florida, LLC
Tampa, Florida, 33609, United States
Southeast Retina Center
Augusta, Georgia, 30909, United States
Georgia Retina PC
Marietta, Georgia, 30060, United States
Illinois Retina Associates
Joliet, Illinois, 60435, United States
University Retina and Macula Associates, PC
Lemont, Illinois, 60439, United States
Wolfe Eye Clinic
West Des Moines, Iowa, 50266, United States
Retina Associates
Lenexa, Kansas, 66215, United States
Retina Associates of Kentucky
Lexington, Kentucky, 40509, United States
Paducah Retinal Center
Paducah, Kentucky, 42001, United States
Maine Eye Center
Portland, Maine, 04101, United States
The Retina Care Center
Baltimore, Maryland, 21209, United States
Johns Hopkins Med; Wilmer Eye Inst
Baltimore, Maryland, 21287, United States
Retina Group of Washington
Chevy Chase, Maryland, 20815, United States
Retina Specialists
Towson, Maryland, 21204, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114, United States
Vitreo-Retinal Associates, PC
Worcester, Massachusetts, 01605, United States
Associated Retinal Consultants
Grand Rapids, Michigan, 49546, United States
Foundation for Vision Research
Grand Rapids, Michigan, 49546, United States
VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota
Edina, Minnesota, 55435, United States
Midwest Vision Research Foundation
Chesterfield, Missouri, 63017, United States
The Retina Institute - Chesterfield
Chesterfield, Missouri, 63017, United States
Sierra Eye Associates
Reno, Nevada, 89502, United States
Envision Ocular, LLC
Bloomfield, New Jersey, 07003, United States
Mid Atlantic Retina - Wills Eye Hospital
Cherry Hill, New Jersey, 08034, United States
NJ Retina Teaneck Clinic
Toms River, New Jersey, 08755, United States
Long Is. Vitreoretinal Consult
Great Neck, New York, 11021, United States
Retina Vit Surgeons/Central NY
Liverpool, New York, 13088, United States
Vitreous-Retina-Macula
New York, New York, 10022, United States
Ophthalmic Consultants of Long Island
Rockville Centre, New York, 11570, United States
Char Eye Ear &Throat Assoc
Charlotte, North Carolina, 28210, United States
Cincinnati Eye Institute
Cincinnati, Ohio, 45242, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
OSU Eye Physicians & Surgeons
Columbus, Ohio, 43212, United States
Retina Vitreous Center
Edmond, Oklahoma, 73013, United States
Retina Northwest
Portland, Oregon, 97221, United States
Palmetto Retina Center
Florence, South Carolina, 29501, United States
Charles Retina Institute
Memphis, Tennessee, 38119, United States
Tennessee Retina PC
Nashville, Tennessee, 37203, United States
Texas Retina Associates
Arlington, Texas, 76012, United States
Austin Retina Associates
Austin, Texas, 78705, United States
Austin Clinical Research LLC
Austin, Texas, 78750, United States
Retina Consultants of Texas
Bellaire, Texas, 77401, United States
Texas Retina Associates
Fort Worth, Texas, 76104, United States
Med Center Ophthalmology Assoc
San Antonio, Texas, 78240, United States
Retina Associates of Utah
Salt Lake City, Utah, 84107, United States
Rocky Mountain Retina
Salt Lake City, Utah, 84107, United States
Wagner Macula & Retina Center
Norfolk, Virginia, 23502, United States
Retina Institute of Virginia
Richmond, Virginia, 23235, United States
Retina Center Northwest
Silverdale, Washington, 98383, United States
Spokane Eye Clinical Research
Spokane, Washington, 99204, United States
Related Publications (7)
Sheth VS, Holekamp NM, Khanani AM, Rachitskaya A, Blotner S, Gune S, Heinrich D, Maass KF, Chakravarthy U. Retinal Fluid and Thickness Fluctuations in Archway Trial for Port Delivery System with Ranibizumab versus Monthly Ranibizumab Injections. Ophthalmol Retina. 2025 Apr;9(4):330-342. doi: 10.1016/j.oret.2024.10.015. Epub 2024 Oct 22.
PMID: 39447871DERIVEDCampochiaro PA, Eichenbaum D, Chang MA, Clark WL, Graff JM, Le Pogam S, Cavichini Cordeiro M, Gune S, Rabena M, Singh N, Lin S, Callaway N. Interim Results of the Phase III Portal Extension Trial of the Port Delivery System with Ranibizumab in Neovascular Age-Related Macular Degeneration. Ophthalmol Retina. 2025 Feb;9(2):144-155. doi: 10.1016/j.oret.2024.05.021. Epub 2024 Aug 30.
PMID: 39209113DERIVEDEichenbaum 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.
PMID: 39154860DERIVEDNielsen JS, Chang A, Holekamp NM, Cavichini-Cordeiro M, Lin SL, Heinrich D, Maass KF, Menezes A, Singh N, Pieramici DJ. Supplemental Intravitreal Ranibizumab Injections in Eyes Treated with the Port Delivery System with Ranibizumab in the Archway Trial. Ophthalmol Retina. 2024 Dec;8(12):1127-1139. doi: 10.1016/j.oret.2024.06.012. Epub 2024 Jun 22.
PMID: 38914294DERIVEDChang MA, Kapre A, Kaufman D, Kardatzke DR, Rabena M, Patel S, Bobbala A, Gune S, Fung A, Wallenstein G. Patient Preference and Treatment Satisfaction With a Port Delivery System for Ranibizumab vs Intravitreal Injections in Patients With Neovascular Age-Related Macular Degeneration: A Randomized Clinical Trial. JAMA Ophthalmol. 2022 Aug 1;140(8):771-778. doi: 10.1001/jamaophthalmol.2022.1091.
PMID: 35708706DERIVEDAwh CC, Barteselli G, Makadia S, Chang RT, Stewart JM, Wieland MR, Brassard R, Callaway NF, Gune S, Heatherton P, Malhotra V, Willis JR, Pieramici DJ. Management of Key Ocular Adverse Events in Patients Implanted with the Port Delivery System with Ranibizumab. Ophthalmol Retina. 2022 Nov;6(11):1028-1043. doi: 10.1016/j.oret.2022.05.011. Epub 2022 May 16.
PMID: 35589078DERIVEDHeimann F, Barteselli G, Brand A, Dingeldey A, Godard L, Hochstetter H, Schneider M, Rothkegel A, Wagner C, Horvath J, Ranade S. A custom virtual reality training solution for ophthalmologic surgical clinical trials. Adv Simul (Lond). 2021 Apr 16;6(1):12. doi: 10.1186/s41077-021-00167-z.
PMID: 33863399DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2018
First Posted
September 19, 2018
Study Start
September 12, 2018
Primary Completion
May 22, 2020
Study Completion
June 9, 2021
Last Updated
October 4, 2022
Results First Posted
March 25, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will share
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).