En enkeltarmsstudie av Aflibercept 8 mg dosert til voksne deltakere med neovaskulær aldersrelatert makuladegenerasjon (nAMD) eller diabetisk makulært ødem (DME) (ELARA)
En fase 3b enarmsstudie av Aflibercept 8 mg hos deltakere med neovaskulær aldersrelatert makuladegenerasjon (nAMD) eller diabetisk makulært ødem (DME)
This study is researching aflibercept high dose (HD), referred to as "study drug", with an experimental dosing regimen. The study is focused on participants with nAMD and DME that have been previously treated with anti-vascular endothelial growth factor (anti-VEGF) medications.
The aim of the study is to see how safe and effective aflibercept HD injections are when given as frequently as every 4 weeks. The study is also looking at what side effects may happen from taking the study drug.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
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California
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Arcadia, California, Forente stater, 91006
- Win Retina - Arcadia
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Bakersfield, California, Forente stater, 93309
- California Retina Consultants
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Beverly Hills, California, Forente stater, 90212
- Retina Specialists of Beverly Hills
-
Huntington Beach, California, Forente stater, 92647
- Salehi Retina Institute dba Retina Associates of Southern California
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Long Beach, California, Forente stater, 90807
- South Coast Retina Center
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Pasadena, California, Forente stater, 91107
- California Eye Specialists Medical Group, Inc.
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Redlands, California, Forente stater, 92374
- Retina Consultants of Southern California
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Sacramento, California, Forente stater, 95825
- Vrmg Inc
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Colorado
-
Colorado Springs, Colorado, Forente stater, 80909
- Retina Consultants of Southern Colorado
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Longmont, Colorado, Forente stater, 80503
- Eye care Center of Northern Colorado doing business as Advanced Vision Research Institute
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Connecticut
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Waterford, Connecticut, Forente stater, 06385
- Retina Group of New England
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Florida
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Deerfield Beach, Florida, Forente stater, 33064
- Advanced Research, LLC
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Jacksonville, Florida, Forente stater, 32216
- Florida Retina Institute - Jacksonville
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Lakeland, Florida, Forente stater, 33805
- Florida Retina Consultants
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Orlando, Florida, Forente stater, 32806
- Florida Retina Institute - Orlando
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Pensacola, Florida, Forente stater, 32503
- Retina Speciality Institute - Pensacola, Florida
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Pinellas Park, Florida, Forente stater, 33782
- Eye Associates of Pinellas
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St. Petersburg, Florida, Forente stater, 33711
- Retina Vitreous Associates of Florida Saint Petersburg
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Tampa, Florida, Forente stater, 33617
- Retina Vitreous Associates of Florida
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Winter Haven, Florida, Forente stater, 33880
- Center for Retina and Macular Disease
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Georgia
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Marietta, Georgia, Forente stater, 30060
- Georgia Retina
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Hawaii
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‘Aiea, Hawaii, Forente stater, 96701
- Retina Consultants of Hawaii, Inc.
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Illinois
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Lemont, Illinois, Forente stater, 60439
- University Retina and Macula Associates PC - Lemont
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Oak Park, Illinois, Forente stater, 60304
- Illinois Retina Associates
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Maryland
-
Hagerstown, Maryland, Forente stater, 21740
- Cumberland Valley Retina Consultants-Ophthalmology
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Hagerstown, Maryland, Forente stater, 21740
- Mid Atlantic Retina Specialists Hagerstown
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Massachusetts
-
Boston, Massachusetts, Forente stater, 02114
- Opthalmic Consultants of Boston
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Minnesota
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Edina, Minnesota, Forente stater, 55435
- Retina Consultants of Minnesota
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Mississippi
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Southaven, Mississippi, Forente stater, 38671
- Deep Blue Retina Clinical Research PLLC
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New Mexico
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Albuquerque, New Mexico, Forente stater, 87109
- Vision Research Center Eye Associates of New Mexico
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New York
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Westbury, New York, Forente stater, 11590
- Vitreoretinal Consultants of NY - Westbury
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North Carolina
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Wake Forest, North Carolina, Forente stater, 27587
- North Carolina Retina Associates
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Ohio
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Beachwood, Ohio, Forente stater, 44122
- Retina Associates of Cleveland - Beachwood
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Cincinnati, Ohio, Forente stater, 45242
- Cincinnati Eye Institute
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Oklahoma
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Tulsa, Oklahoma, Forente stater, 74114
- Tulsa Retina Consultants
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Oregon
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Portland, Oregon, Forente stater, 97225
- EyeHealth Northwest
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Pennsylvania
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Bethlehem, Pennsylvania, Forente stater, 18017
- Mid Atlantic Retina
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Sewickley, Pennsylvania, Forente stater, 15143
- Sewickley Eye Group
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South Carolina
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Ladson, South Carolina, Forente stater, 29456
- Charleston Neuroscience Institute LLC
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West Columbia, South Carolina, Forente stater, 29169
- Palmetto Retina Center
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Tennessee
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Nashville, Tennessee, Forente stater, 37203
- Tennessee Retina, PC
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Texas
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Abilene, Texas, Forente stater, 79606
- Retina Research Institute of Texas
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Austin, Texas, Forente stater, 78705
- Austin Retina Associates
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Beaumont, Texas, Forente stater, 77707
- Retina Consultants of Texas
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Bellaire, Texas, Forente stater, 77401
- Retina Consultants of Texas - Houston
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Dallas, Texas, Forente stater, 75231
- Texas Retina Associates - Dallas
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El Paso, Texas, Forente stater, 79902
- Southwest Retina Consultants
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Katy, Texas, Forente stater, 77494
- Retina Consultants of Texas
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Round Rock, Texas, Forente stater, 78681
- Austin Retina Associates
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San Antonio, Texas, Forente stater, 78240
- Retina Consultants of Texas
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San Antonio, Texas, Forente stater, 78251
- Retina Consultants of Texas Brown Retina Institute
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The Woodlands, Texas, Forente stater, 77384
- Retina Consultants Texas
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Washington
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Bellevue, Washington, Forente stater, 98004
- Pacific Northwest Retina
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-
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Arecibo, Puerto Rico, 00612
- Emanuelli Research and Development Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Key Inclusion Criteria for Participants with nAMD:
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≥50 years of age
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History of choroidal neovascularization (CNV) lesions secondary to nAMD in the eye study, requiring continued anti-VEGF treatment, as determined by the investigator.
Key Inclusion Criteria for Participants with DME:
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≥18 years of age
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History of DME with central involvement (in the central subfield on Spectral domain optical coherence tomography [SD-OCT]) in the study eye, requiring continued anti-VEGF treatment, as determined by the investigator
Key Inclusion for All Participants:
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Previously treated with ≥3 anti-VEGF IVT injections in the study eye in the 5 months (~150 days) prior to visit 1
Key Exclusion Criteria for Participants with nAMD:
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Evidence of CNV due to any cause other than nAMD in either eye
Key Exclusion Criteria for Participants with DME:
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Evidence of macular edema due to any other cause other than diabetes mellitus in the study eye
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Active proliferative diabetic retinopathy (DR) in the study eye
NOTE: Other protocol defined inclusion / exclusion criteria apply.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Aflibercept 8 mg
Participants previously treated with anti-vascular endothelial growth factor (anti-VEGF) medications |
Administered by intravitreal (IVT) injection
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Participants With at Least One Treatment-emergent Adverse Event (TEAE)
Tidsramme: Through week 24
|
Through week 24
|
|
Participants With at Least One Serious TEAE
Tidsramme: Through week 24
|
Through week 24
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Clinical Trial Management, Regeneron Pharmaceuticals
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- VGFTe-HD-OD-2444
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
IPD-delingstidsramme
When Regeneron has:
- received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued developed of the product for all indications on or after April 2020 and has no plans for future development
- made results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
- the legal authority to share the data, and
- ensured the ability to protect participant privacy.
Tilgangskriterier for IPD-deling
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- ANALYTIC_CODE
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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