Wet Age-related Macular Degeneration (wAMD)Phase 3HEIRLOOMNCT07129239
High Dose (HD) Aflibercept Switch in Neovascular Age-related Macular Degeneration (nAMD): to Load or Maintain (HEIRLOOM)
A Phase 3 study testing Maintenance in people with Wet Age-related Macular Degeneration (wAMD), run by Clinique de Retine de l'est at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wet Age-related Macular Degeneration (wAMD)
- What is being tested?
- Maintenance
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteCanada
- Study dates
- 20 Aug 2025to Feb 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Clinique de Retine de L'Est
Montreal, Quebec, H1Y0E2
Cynthia Lacasse, 5143205045, clacasse.retinedelest@gmail.com
Andrei Szigiato, Docteur
About this study
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.
Read more
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.
- Being tested
- Maintenance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaintenanceOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 and 12 month
Secondary outcomes (7)
Visual Acuity
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.
Measured: 6 and 12 month
Number of injections
duration between last injection at 6 months and 12 months from date of the switch measured
Measured: 6 and 12 month
Adverse events
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.
Measured: 6 and 12 month
Presence of Subretinal Fluid (Yes/No)
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).
Measured: 6 months and 12 months
Presence of Intraretinal Fluid (Yes/No)
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).
Measured: 6 months and 12 months
Pigment Epithelial Detachment (PED) Type
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).
Measured: 6 months and 12 months
Pigment Epithelial Detachment (PED) Height
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).
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start20 Aug 2025 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wet Age-related Macular Degeneration (wAMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique de Retine de l'est
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Dr. Andrei Szigiato, Clinique de Retine de l'est
- Investigators
- Andrei Szigiato, Docteur, Principal investigator, Clinique de Retine de l'est
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129239
- Sponsor's protocol ID
- 23002
- Acronym
- HEIRLOOM
- Status last verified
- Aug 2025
- First submitted
- 10 Jul 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Dose (HD) Aflibercept Switch in Neovascular Age-related Macular Degeneration (nAMD): to Load or Maintain (HEIRLOOM)
- ClinicalTrials.gov ID
- NCT07129239
- Acronym / sponsor ID
- HEIRLOOM / 23002
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Clinique de Retine de l'estUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 20 Aug 2025 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Maintenancepatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MaintenancePatients 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 | Other | Maintenance interval group |
Primary outcome
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).
7 secondary outcomes
Visual Acuity
Time frame: 6 and 12 month
Number of injections
Time frame: 6 and 12 month
Adverse events
Time frame: 6 and 12 month
Presence of Subretinal Fluid (Yes/No)
Time frame: 6 months and 12 months
Presence of Intraretinal Fluid (Yes/No)
Time frame: 6 months and 12 months
Pigment Epithelial Detachment (PED) Type
Time frame: 6 months and 12 months
Pigment Epithelial Detachment (PED) Height
Time frame: 6 months and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrei Szigiato, Docteur principal investigator
Clinique de Retine de l'est
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Maintenance in people with Wet Age-related Macular Degeneration (wAMD), run by Clinique de Retine de l'est at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cynthia lacasse (5143205045, clacasse.retinedelest@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central Retinal Thickness (CRT) (time frame: 6 and 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.