ZIMURA in Combination With LUCENTIS in Patients With Neovascular Age Related Macular Degeneration (NVAMD)
NCT ID: NCT03362190
Last Updated: 2025-06-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
64 participants
INTERVENTIONAL
2017-10-11
2018-10-18
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
NONE
Study Groups
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Cohort 1
Avacincaptad Pegol dosage 1 + Lucentis 0.5 mg
Avacincaptad Pegol
Avacincaptad Pegol in combination with Lucentis
Lucentis
Avacincaptad Pegol in combination with Lucentis
Cohort 2
Avacincaptad Pegol dosage 2 + Lucentis 0.5 mg
Avacincaptad Pegol
Avacincaptad Pegol in combination with Lucentis
Lucentis
Avacincaptad Pegol in combination with Lucentis
Cohort 3
Avacincaptad Pegol dosage 3 + Lucentis 0.5 mg
Avacincaptad Pegol
Avacincaptad Pegol in combination with Lucentis
Lucentis
Avacincaptad Pegol in combination with Lucentis
Cohort 4
Avacincaptad Pegol dosage 4 + Lucentis 0.5 mg
Avacincaptad Pegol
Avacincaptad Pegol in combination with Lucentis
Lucentis
Avacincaptad Pegol in combination with Lucentis
Interventions
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Avacincaptad Pegol
Avacincaptad Pegol in combination with Lucentis
Lucentis
Avacincaptad Pegol in combination with Lucentis
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Any major surgical procedure within one month of trial entry
* Subjects with a clinically significant laboratory value
* Any treatment with an investigational agent in the past 60 days for any condition
* Women who are pregnant or nursing
* Known serious allergies to the fluorescein dye used in angiography, povidone iodine, to the components of the ranibizumab formulation, or to the components of the Zimura formulation
* Any prior treatment for AMD other than oral supplements of vitamins and minerals
50 Years
ALL
No
Sponsors
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Ophthotech Corporation
INDUSTRY
Responsible Party
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Locations
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Retinal Research Institute
Phoenix, Arizona, United States
Retina Centers PC
Tucson, Arizona, United States
Retina Associates SW, PC
Tucson, Arizona, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
Retina Consultants of Orange County
Fullerton, California, United States
Retina Consultants of Southern California
Redlands, California, United States
Retinal Consultants Medical Group
Sacramento, California, United States
Orange County Retina Medical Group
Santa Ana, California, United States
Colorado Retina Associates
Golden, Colorado, United States
Florida Eye Clinic
Altamonte Springs, Florida, United States
Florida Eye Associates
Melbourne, Florida, United States
Illinois Eye Center
Peoria, Illinois, United States
Vitreo Retinal Consultants & Surgeons
Wichita, Kansas, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States
VitreoRetinal Surgery
Minneapolis, Minnesota, United States
Retina Consultants of Nevada
Henderson, Nevada, United States
Sierra Eye Associates
Reno, Nevada, United States
Retina Vitreous Surgeons of CNY, PC
Syracuse, New York, United States
Retina Northwest PC
Portland, Oregon, United States
Mid Atlantic Retina
Philadelphia, Pennsylvania, United States
Charleston Neuroscience Institute
Ladson, South Carolina, United States
Retina Research Institute of Texas
Abilene, Texas, United States
Strategic Clinical Research Group
Willow Park, Texas, United States
Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont
Budapest, , Hungary
Budapest Retina Associates
Budapest, , Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Szemeszeti Klinika
Szeged, , Hungary
Pauls Stradins Clinical University Hospital, Clinic of Ophthalmology
Riga, , Latvia
Dr. Solomatin's eye rehabilitation and vision correction centre
Riga, , Latvia
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Link to plain language summary of the study on the Trial Results Summaries website
Link to results and other applicable study documents on the Astellas Clinical Trials website
Other Identifiers
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OPH2007
Identifier Type: -
Identifier Source: org_study_id
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