High Dose (HD) Aflibercept Switch in Neovascular Age-related Macular Degeneration (nAMD): to Load or Maintain (HEIRLOOM)
NCT ID: NCT07129239
Last Updated: 2025-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
180 participants
INTERVENTIONAL
2025-08-20
2027-02-28
Brief Summary
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EYLEA® HD is approved by Health Canada has been tested in large clinical trials involving thousands of patients around the world and has been shown effective in the treatment of wAMD. The treatment regimen used in these trials involved 3 initial monthly injections of EYLEA® HD followed by an extension of the treatment interval on the 4th visit. This was necessary since all patients in this study did not previously have treatment injections for wAMD.
Currently there is not enough information on the best treatment regimen to use for patients that are switched to EYLEA® HD from EYLEA®.
Health Canada currently recommends that EYLEA® HD is administered every month for the first 3 doses, followed by a treatment every 8 to 16 weeks.
A total of 180 patients \>18 years of age will participate in this study, which will be conducted at the Clinique de Retine de l'Est in Montreal, Quebec, Canada.
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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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Loading interval group
patients who are currently being treated with EYLEA® (aflibercept 2mg) will be switched to EYLEA® HD (aflibercept 8mg) and receive injections every month for the first 3 months followed by an extension (or increase in dosing interval) of therapy based on clinical response. This is the "on label" treatment regimen approved by Health Canada.
No interventions assigned to this group
Maintenance interval group
patients who are currently being treated with EYLEA® (aflibercept 2mg) will be switched to EYLEA® HD (aflibercept 8mg) and maintain the current treatment interval that they had with EYLEA® (aflibercept 2mg), followed by an extension of therapy (or increase in treatment dosing interval) based on clinical response. This is the "off-label" treatment regimen that we are testing to see if it is as effective and involves less treatment burden.
Maintenance
Patients who are currently being treated with EYLEA® (aflibercept 2mg) will be switched to EYLEA® HD (aflibercept 8mg) and maintain the current treatment interval that they had with EYLEA® (aflibercept 2mg), followed by an extension of therapy (or increase in treatment dosing interval) based on clinical response
Interventions
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Maintenance
Patients who are currently being treated with EYLEA® (aflibercept 2mg) will be switched to EYLEA® HD (aflibercept 8mg) and maintain the current treatment interval that they had with EYLEA® (aflibercept 2mg), followed by an extension of therapy (or increase in treatment dosing interval) based on clinical response
Eligibility Criteria
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Inclusion Criteria
* Patients with neovascular AMD
* Patients who have received aflibercept 2mg for a minimum of 3 loading injections plus 2 maintenance injections.
* Can include 1 or 2 eyes per patient if one or both meet study criteria.
Exclusion Criteria
* Polypoidal choroidal vasculopathy
* Macular dystrophies (ie. Pattern dystrophy, central areolar etc.)
* Toxic/drug induced maculopathies
* Disciform scar
* Subfoveal atrophy
* Previous Photodynamic Therapy (PDT) or focal laser
* Is currently enrolled in another clinical study or observational study
* Active use of a different agent in the fellow eye, to avoid cross-over effects of anti Vascular Endothelial Growth Factor (VEGF) administration to the fellow eye
* If the patient is pregnant
18 Years
ALL
No
Sponsors
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Clinique de Retine de l'est
OTHER
Bayer
INDUSTRY
Responsible Party
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Dr. Andrei Szigiato
Principal Investigator
Principal Investigators
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Andrei Szigiato, Docteur
Role: PRINCIPAL_INVESTIGATOR
Clinique de Retine de l'est
Locations
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Clinique de Retine de L'Est
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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23002
Identifier Type: -
Identifier Source: org_study_id
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