NCT07129239Not yet recruitingPhase 3
High Dose (HD) Aflibercept Switch in Neovascular Age-related Macular Degeneration (nAMD): to Load or Maintain (HEIRLOOM)
Source: ClinicalTrials.gov · Last updated 19 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 10 Jul 2025
- Start date
- 20 Aug 2025
- Primary completion date
- 28 Feb 2027
- Lead sponsor
- Clinique de Retine de l'est
- Diseases
- Macular degeneration
- NCT number
- NCT07129239
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 180
- From 20 Aug 2025 to the primary completion date, 28 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Toxic/drug induced maculopathies
- Previous Photodynamic Therapy (PDT) or focal laser
Other
- Patients with other maculopathy, including but not limited to:
- Polypoidal choroidal vasculopathy
- Macular dystrophies (ie. Pattern dystrophy, central areolar etc.)
- Disciform scar
- Subfoveal atrophy
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinique de Retine de L'Est Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.