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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aflibercept 8 mg | Experimental | Participants previously treated with anti-vascular endothelial growth factor (anti-VEGF) medications |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept 8 mg | Drug | Administered by intravitreal (IVT) injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of treatment-emergent adverse events (TEAEs) | Through week 24 | |
| Occurrence of serious TEAEs | Through week 24 |
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Key Inclusion Criteria for Participants with nAMD:
≥50 years of age
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:
≥18 years of age
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:
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:
Evidence of CNV due to any cause other than nAMD in either eye
Key Exclusion Criteria for Participants with DME:
Evidence of macular edema due to any other cause other than diabetes mellitus in the study eye
Active proliferative diabetic retinopathy (DR) in the study eye
NOTE: Other protocol defined inclusion / exclusion criteria apply.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Win Retina - Arcadia | Arcadia | California | 91006 | United States | ||
| California Retina Consultants |
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
When Regeneron has:
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
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| Bakersfield |
| California |
| 93309 |
| United States |
| Retina Specialists of Beverly Hills | Beverly Hills | California | 90212 | United States |
| Salehi Retina Institute dba Retina Associates of Southern California | Huntington Beach | California | 92647 | United States |
| South Coast Retina Center | Long Beach | California | 90807 | United States |
| California Eye Specialists Medical Group, Inc. | Pasadena | California | 91107 | United States |
| Retina Consultants of Southern California | Redlands | California | 92374 | United States |
| Vrmg Inc | Sacramento | California | 95825 | United States |
| Retina Consultants of Southern Colorado | Colorado Springs | Colorado | 80909 | United States |
| Eye care Center of Northern Colorado doing business as Advanced Vision Research Institute | Longmont | Colorado | 80503 | United States |
| Retina Group of New England | Waterford | Connecticut | 06385 | United States |
| Advanced Research, LLC | Deerfield Beach | Florida | 33064 | United States |
| Florida Retina Institute - Jacksonville | Jacksonville | Florida | 32216 | United States |
| Florida Retina Consultants | Lakeland | Florida | 33805 | United States |
| Florida Retina Institute - Orlando | Orlando | Florida | 32806 | United States |
| Retina Speciality Institute - Pensacola, Florida | Pensacola | Florida | 32503 | United States |
| Eye Associates of Pinellas | Pinellas Park | Florida | 33782 | United States |
| Retina Vitreous Associates of Florida Saint Petersburg | St. Petersburg | Florida | 33711 | United States |
| Retina Vitreous Associates of Florida | Tampa | Florida | 33617 | United States |
| Center for Retina and Macular Disease | Winter Haven | Florida | 33880 | United States |
| Georgia Retina | Marietta | Georgia | 30060 | United States |
| Retina Consultants of Hawaii, Inc. | ‘Aiea | Hawaii | 96701 | United States |
| University Retina and Macula Associates PC - Lemont | Lemont | Illinois | 60439 | United States |
| Illinois Retina Associates | Oak Park | Illinois | 60304 | United States |
| Cumberland Valley Retina Consultants-Ophthalmology | Hagerstown | Maryland | 21740 | United States |
| Mid Atlantic Retina Specialists Hagerstown | Hagerstown | Maryland | 21740 | United States |
| Opthalmic Consultants of Boston | Boston | Massachusetts | 02114 | United States |
| Retina Consultants of Minnesota | Edina | Minnesota | 55435 | United States |
| Deep Blue Retina Clinical Research PLLC | Southaven | Mississippi | 38671 | United States |
| Vision Research Center Eye Associates of New Mexico | Albuquerque | New Mexico | 87109 | United States |
| Vitreoretinal Consultants of NY - Westbury | Westbury | New York | 11590 | United States |
| North Carolina Retina Associates | Wake Forest | North Carolina | 27587 | United States |
| Retina Associates of Cleveland - Beachwood | Beachwood | Ohio | 44122 | United States |
| Cincinnati Eye Institute | Cincinnati | Ohio | 45242 | United States |
| Tulsa Retina Consultants | Tulsa | Oklahoma | 74114 | United States |
| EyeHealth Northwest | Portland | Oregon | 97225 | United States |
| Mid Atlantic Retina | Bethlehem | Pennsylvania | 18017 | United States |
| Sewickley Eye Group | Sewickley | Pennsylvania | 15143 | United States |
| Charleston Neuroscience Institute LLC | Ladson | South Carolina | 29456 | United States |
| Palmetto Retina Center | West Columbia | South Carolina | 29169 | United States |
| Tennessee Retina, PC | Nashville | Tennessee | 37203 | United States |
| Retina Research Institute of Texas | Abilene | Texas | 79606 | United States |
| Austin Retina Associates | Austin | Texas | 78705 | United States |
| Retina Consultants of Texas | Beaumont | Texas | 77707 | United States |
| Retina Consultants of Texas - Houston | Bellaire | Texas | 77401 | United States |
| Texas Retina Associates - Dallas | Dallas | Texas | 75231 | United States |
| Southwest Retina Consultants | El Paso | Texas | 79902 | United States |
| Retina Consultants of Texas | Katy | Texas | 77494 | United States |
| Austin Retina Associates | Round Rock | Texas | 78681 | United States |
| Retina Consultants of Texas | San Antonio | Texas | 78240 | United States |
| Retina Consultants of Texas Brown Retina Institute | San Antonio | Texas | 78251 | United States |
| Retina Consultants Texas | The Woodlands | Texas | 77384 | United States |
| Pacific Northwest Retina | Bellevue | Washington | 98004 | United States |
| Emanuelli Research and Development Center | Arecibo | 00612 | Puerto Rico |
| ID | Term |
|---|---|
| C533178 | aflibercept |
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