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NCT07129239: HEIRLOOM
High Dose (HD) Aflibercept Switch in Neovascular Age-related Macular Degeneration (nAMD): to Load or Maintain (HEIRLOOM)
Phase 3 trial testing Maintenance in Wet Age-related Macular Degeneration (wAMD) in 180 participants. Not yet recruiting.
1 February 2027
Quick facts
| Lead sponsor | Clinique de Retine de l'est |
|---|---|
| Phase | Phase 3 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 180 |
| Start date | 20 August 2025 |
| Primary completion | 1 February 2027 |
| Estimated completion | 1 February 2027 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Maintenance — full drug profile →
Conditions studied
- Wet Age-related Macular Degeneration (wAMD) — all drugs for Wet Age-related Macular Degeneration (wAMD) →
Sponsor
Clinique de Retine de l'est
Who can join
18 and older, any sex, with Wet Age-related Macular Degeneration (wAMD). Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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).
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07129239
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Wet Age-related Macular Degeneration (wAMD)
Currently open trials in the same condition.
- NCT06718816 — Long-term Follow-up Study of AL-001 Ophthalmic Injection in Subjects with WAMD · recruiting
- NCT06707753 — Safety and Tolerability of AL-001 Ophthalmic Injection in Subjects with WAMD · Phase 1, PHASE2 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07129239 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Clinique de Retine de l'est
- Last refreshed: 11 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07129239.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing