High Dose (HD) Aflibercept Switch in Neovascular Age-related Macular Degeneration (nAMD): to Load or Maintain (HEIRLOOM)

NCT07129239 | Not Yet Recruiting Phase 3

• 1 other identifier: 23002
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare two treatment frequencies using EYLEA® HD (aflibercept 8mg) in patients with wet age-related macular degeneration (wAMD) that are currently treated with EYLEA® (aflibercept 2mg). 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.

Conditions

Wet Age-related Macular Degeneration (wAMD)

Outcome Measures

Primary Outcomes (1)

• Central Retinal Thickness (CRT)

  The primary endpoint will derived from Optical Coherence Tomography (OCT), in µm and measured at 12 months after switching therapies with interim analysis at 6 months (Detected on 8 line radial scans, through the fovea).

  6 and 12 month

Secondary Outcomes (7)

• Visual Acuity

  6 and 12 month

• Number of injections

  6 and 12 month

• Adverse events

  6 and 12 month

• Presence of Subretinal Fluid (Yes/No)

  6 months and 12 months

• Presence of Intraretinal Fluid (Yes/No)

  6 months and 12 months

Study Arms (2)

Loading interval group

NO INTERVENTION

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.

Maintenance interval group

EXPERIMENTAL

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.

Other: Maintenance

Interventions

Maintenance OTHER

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

Maintenance interval group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over the age of 18
• 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.

You may not qualify if:

• Patients with other maculopathy, including but not limited to:
• 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

Sponsors & Collaborators

• Clinique de Retine de l'est: lead
• Bayer: collaborator

Study Sites (1)

Clinique de Retine de L'Est

Montreal, Quebec, H1Y0E2, Canada

Location

MeSH Terms

Interventions

Maintenance

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Study Officials

• Andrei Szigiato, Docteur

  Clinique de Retine de l'est

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cynthia lacasse

CONTACT

5143205045; clacasse.retinedelest@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: August 19, 2025
• Study Start: August 20, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)