Clinical trial NCT06491914: A Phase 3b, Single-Arm Study of Aflibercept 8 mg Dosed Every 4 Weeks in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME)
Official title: A Phase 3b Single-Arm Study of Aflibercept 8 mg in Participants With Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Neovascular Age-Related Macular Degeneration
Diabetic Macular Edema
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2024-07-09
Enrollment: 1118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Key Inclusion Criteria for Participants with nAMD:

1. ≥50 years of age
2. 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:
3. ≥18 years of age
4. 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:
5. 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:

1. Evidence of CNV due to any cause other than nAMD in either eye

   Key Exclusion Criteria for Participants with DME:
2. Evidence of macular edema due to any other cause other than diabetes mellitus in the study eye
3. Active proliferative diabetic retinopathy (DR) in the study eye

NOTE: Other protocol defined inclusion / exclusion criteria apply.

Primary outcomes:
measure: Occurrence of treatment-emergent adverse events (TEAEs)
timeFrame: Through week 24
measure: Occurrence of serious TEAEs
timeFrame: Through week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Arcadia
country: United States
facility: Win Retina - Arcadia
state: California
city: Bakersfield
country: United States
facility: California Retina Consultants
state: California
city: Beverly Hills
country: United States
facility: Retina Specialists of Beverly Hills
state: California
city: Huntington Beach
country: United States
facility: Salehi Retina Institute dba Retina Associates of Southern California
state: California
city: Long Beach
country: United States
facility: South Coast Retina Center
state: California
city: Pasadena
country: United States
facility: California Eye Specialists Medical Group, Inc.
state: California
city: Redlands
country: United States
facility: Retina Consultants of Southern California
state: California
city: Sacramento
country: United States
facility: Vrmg Inc
state: California
city: Colorado Springs
country: United States
facility: Retina Consultants of Southern Colorado
state: Colorado
city: Longmont
country: United States
facility: Eye care Center of Northern Colorado doing business as Advanced Vision Research Institute
state: Colorado
city: Waterford
country: United States
facility: Retina Group of New England
state: Connecticut
city: Deerfield Beach
country: United States
facility: Advanced Research, LLC
state: Florida
city: Jacksonville
country: United States
facility: Florida Retina Institute - Jacksonville
state: Florida
city: Lakeland
country: United States
facility: Florida Retina Consultants
state: Florida
city: Orlando
country: United States
facility: Florida Retina Institute - Orlando
state: Florida
city: Pensacola
country: United States
facility: Retina Speciality Institute - Pensacola, Florida
state: Florida
city: Pinellas Park
country: United States
facility: Eye Associates of Pinellas
state: Florida
city: Saint Petersburg
country: United States
facility: Retina Vitreous Associates of Florida Saint Petersburg
state: Florida
city: Tampa
country: United States
facility: Retina Vitreous Associates of Florida
state: Florida
city: Winter Haven
country: United States
facility: Center for Retina and Macular Disease
state: Florida
city: Marietta
country: United States
facility: Georgia Retina
state: Georgia
city: 'Aiea
country: United States
facility: Retina Consultants of Hawaii, Inc.
state: Hawaii
city: Lemont
country: United States
facility: University Retina and Macula Associates PC - Lemont
state: Illinois
city: Oak Park
country: United States
facility: Illinois Retina Associates
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic Main Campus East
state: Illinois
city: Hagerstown
country: United States
facility: Cumberland Valley Retina Consultants-Ophthalmology
state: Maryland
city: Hagerstown
country: United States
facility: Mid Atlantic Retina Specialists Hagerstown
state: Maryland
city: Boston
country: United States
facility: Opthalmic Consultants of Boston
state: Massachusetts
city: Edina
country: United States
facility: Retina Consultants of Minnesota
state: Minnesota
city: Southaven
country: United States
facility: Deep Blue Retina Clinical Research PLLC
state: Mississippi
city: Edison
country: United States
facility: NJ Retina
state: New Jersey
city: Albuquerque
country: United States
facility: Vision Research Center Eye Associates of New Mexico
state: New Mexico
city: Westbury
country: United States
facility: Vitreoretinal Consultants of NY - Westbury
state: New York
city: Wake Forest
country: United States
facility: North Carolina Retina Associates
state: North Carolina
city: Beachwood
country: United States
facility: Retina Associates of Cleveland - Beachwood
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Tulsa
country: United States
facility: Tulsa Retina Consultants
state: Oklahoma
city: Portland
country: United States
facility: EyeHealth Northwest
state: Oregon
city: Bethlehem
country: United States
facility: Mid Atlantic Retina
state: Pennsylvania
city: Sewickley
country: United States
facility: Sewickley Eye Group
state: Pennsylvania
city: Ladson
country: United States
facility: Charleston Neuroscience Institute LLC
state: South Carolina
city: West Columbia
country: United States
facility: Palmetto Retina Center
state: South Carolina
city: Nashville
country: United States
facility: Tennessee Retina, PC
state: Tennessee
city: Abilene
country: United States
facility: Retina Research Institute of Texas
state: Texas
city: Austin
country: United States
facility: Austin Retina Associates
state: Texas
city: Beaumont
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Bellaire
country: United States
facility: Retina Consultants of Texas - Houston
state: Texas
city: Dallas
country: United States
facility: Texas Retina Associates - Dallas
state: Texas
city: El Paso
country: United States
facility: Southwest Retina Consultants
state: Texas
city: Katy
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Round Rock
country: United States
facility: Austin Retina Associates
state: Texas
city: San Antonio
country: United States
facility: San Antonio Eye Center - Downtown Clinic
state: Texas
city: San Antonio
country: United States
facility: Retina Consultants of Texas
state: Texas
city: San Antonio
country: United States
facility: Retina Consultants of Texas Brown Retina Institute
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants Texas
state: Texas
city: Fairfax
country: United States
facility: Retina Group of Washington
state: Virginia
city: Bellevue
country: United States
facility: Pacific Northwest Retina
state: Washington
city: Arecibo
country: Puerto Rico
facility: Emanuelli Research and Development Center
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: