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
NCT ID: NCT03677934
Last Updated: 2022-10-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
415 participants
INTERVENTIONAL
2018-09-12
2021-06-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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PDS Implant Arm
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
PDS Implant filled with 100 mg/mL Ranibizumab
Will be administered as per the schedule described in individual arm.
Intravitreal Arm
Participants will receive ranibizumab 0.5 mg monthly intravitreal injections of 10 mg/mL formulation at Day 1 and every month thereafter.
Intravitreal Injections of 10 mg/mL Ranibizumab
Will be administered as per the schedule described in individual arm.
Interventions
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PDS Implant filled with 100 mg/mL Ranibizumab
Will be administered as per the schedule described in individual arm.
Intravitreal Injections of 10 mg/mL Ranibizumab
Will be administered as per the schedule described in individual arm.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* Chronic use of oral corticosteroids
* Active cancer within 12 months of randomization
* Previous participation in any non-ocular (systemic) disease studies of investigational drugs within 1 month preceding the informed consent (excluding vitamins and minerals)
50 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Barnet Dulaney Perkins Eye Center
Mesa, Arizona, United States
Associated Retina Consultants
Phoenix, Arizona, United States
Arizona Retina and Vitreous 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
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; Ophthalmology
San Francisco, California, United States
Orange County Retina Med Group
Santa Ana, California, United States
California Retina Consultants
Santa Barbara, California, United States
Bay Area Retina Associates
Walnut Creek, 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
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
Lemont, 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; Wilmer Eye Inst
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
Vitreo-Retinal Associates, PC
Worcester, Massachusetts, United States
Associated Retinal Consultants
Grand Rapids, Michigan, United States
Foundation for Vision Research
Grand Rapids, Michigan, United States
VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota
Edina, Minnesota, United States
Midwest Vision Research Foundation
Chesterfield, Missouri, United States
The Retina Institute - Chesterfield
Chesterfield, Missouri, United States
Sierra Eye Associates
Reno, Nevada, United States
Envision Ocular, LLC
Bloomfield, New Jersey, United States
Mid Atlantic Retina - Wills Eye Hospital
Cherry Hill, New Jersey, United States
NJ Retina Teaneck Clinic
Toms River, New Jersey, United States
Long Is. Vitreoretinal Consult
Great Neck, New York, United States
Retina Vit Surgeons/Central NY
Liverpool, New York, United States
Vitreous-Retina-Macula
New York, New York, United States
Ophthalmic Consultants of Long Island
Rockville Centre, 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
Palmetto Retina Center
Florence, South Carolina, United States
Charles Retina Institute
Memphis, 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 Associates of Utah
Salt Lake City, Utah, United States
Rocky Mountain Retina
Salt Lake City, Utah, United States
Wagner Macula & Retina Center
Norfolk, Virginia, United States
Retina Institute of Virginia
Richmond, Virginia, United States
Retina Center Northwest
Silverdale, Washington, United States
Spokane Eye Clinical Research
Spokane, Washington, United States
Countries
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References
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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.
Campochiaro 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.
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.
Nielsen 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.
Chang 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.
Awh 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.
Heimann 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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GR40548
Identifier Type: -
Identifier Source: org_study_id
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