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)

NCT06491914
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Phase
Phase 3
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Recruitment status
Active, not recruiting
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Participants
1,118
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Lead sponsor
Regeneron Pharmaceuticals
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Start date
2024-07-24
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Number of sites
54
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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.
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Acronym
ELARA
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Short title
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)
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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)
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2027-01-07
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First posted
2024-07-09
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Registry last updated
2025-10-15
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Primary completion date
2025-08-26
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Start date
2024-07-24
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Actual participants
1,118
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Participants
1,118
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Participant count basis
Actual
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Protocol amendments
3
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Number of sites
54
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Regeneron Pharmaceuticals
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06491914
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ClinicalTrials.gov ID
NCT06491914
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Registry record
Open registry record
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Allocation
Not applicable
Model
Single group
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Occurrence of treatment-emergent adverse events (TEAEs)

    Timeframe: Through week 24

  2. Occurrence of serious TEAEs

    Timeframe: Through week 24

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

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.

Sources for eligibility
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  • Win Retina - ArcadiaArcadia, United States
  • California Retina ConsultantsBakersfield, United States
  • Retina Specialists of Beverly HillsBeverly Hills, United States
  • Salehi Retina Institute dba Retina Associates of Southern CaliforniaHuntington Beach, United States
  • South Coast Retina CenterLong Beach, United States
  • California Eye Specialists Medical Group, Inc.Pasadena, United States
  • Retina Consultants of Southern CaliforniaRedlands, United States
  • Vrmg IncSacramento, United States
  • Retina Consultants of Southern ColoradoColorado Springs, United States
  • Eye care Center of Northern Colorado doing business as Advanced Vision Research InstituteLongmont, United States
  • Retina Group of New EnglandWaterford, United States
  • Advanced Research, LLCDeerfield Beach, United States
  • Florida Retina Institute - JacksonvilleJacksonville, United States
  • Florida Retina ConsultantsLakeland, United States
  • Florida Retina Institute - OrlandoOrlando, United States
  • Retina Speciality Institute - Pensacola, FloridaPensacola, United States
  • Eye Associates of PinellasPinellas Park, United States
  • Retina Vitreous Associates of Florida Saint PetersburgSt. Petersburg, United States
  • Retina Vitreous Associates of FloridaTampa, United States
  • Center for Retina and Macular DiseaseWinter Haven, United States
  • Georgia RetinaMarietta, United States
  • Retina Consultants of Hawaii, Inc.‘Aiea, United States
  • University Retina and Macula Associates PC - LemontLemont, United States
  • Illinois Retina AssociatesOak Park, United States
  • Cumberland Valley Retina Consultants-OphthalmologyHagerstown, United States

And 29 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (2)