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

August 11, 2025 updated by: Dr. Andrei Szigiato, Clinique de Retine de l'est

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H1Y0E2
        • Clinique de Retine de L'Est
        • Contact:
        • Principal Investigator:
          • Andrei Szigiato, Docteur
        • Sub-Investigator:
          • Cynthia Qian, doctor
        • Sub-Investigator:
          • Sebastien olivier, doctor
        • Sub-Investigator:
          • Flavio Rezende, doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: 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.
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Central Retinal Thickness (CRT)
Time Frame: 6 and 12 month
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Acuity
Time Frame: 6 and 12 month
Visual acuity measured by the Snellen method and then converted to Early Treatment Diabetic Retinopathy Study (EDTRS) letters. Change in visual acuity will be assessed at 6 and 12 months compared to baseline.
6 and 12 month
Number of injections
Time Frame: 6 and 12 month
duration between last injection at 6 months and 12 months from date of the switch measured
6 and 12 month
Adverse events
Time Frame: 6 and 12 month
Will be reported at 6 and 12 months from date of the switch measured by frequency of events (numerical), as well as descriptive for what type of adverse event.
6 and 12 month
Presence of Subretinal Fluid (Yes/No)
Time Frame: 6 months and 12 months
This measure will be derived from Optical Coherence Tomography (OCT), and measured at 12 months after switching therapies with interim analysis at 6 months (Detected on 8 line radial scans, through the fovea).
6 months and 12 months
Presence of Intraretinal Fluid (Yes/No)
Time Frame: 6 months and 12 months
This measure will be derived from Optical Coherence Tomography (OCT), and measured at 12 months after switching therapies with interim analysis at 6 months (Detected on 8 line radial scans, through the fovea).
6 months and 12 months
Pigment Epithelial Detachment (PED) Type
Time Frame: 6 months and 12 months
Morphology and type of PED will be derived from Optical Coherence Tomography (OCT), and measured at 12 months after switching therapies with interim analysis at 6 months (Detected on 8 line radial scans, through the fovea).
6 months and 12 months
Pigment Epithelial Detachment (PED) Height
Time Frame: 6 months and 12 months
This outcome measure will be derived from Optical Coherence Tomography (OCT), measured in um, and measured at 12 months after switching therapies with interim analysis at 6 months (Detected on 8 line radial scans, through the fovea).
6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinique de Retine de l'est

Collaborators

Bayer

Investigators

  • Principal Investigator: Andrei Szigiato, Docteur, Clinique de Retine de L'Est

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 20, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

July 10, 2025

First Submitted That Met QC Criteria

August 11, 2025

First Posted (Actual)

August 19, 2025

Study Record Updates

Last Update Posted (Actual)

August 19, 2025

Last Update Submitted That Met QC Criteria

August 11, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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