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NCT07129239: HEIRLOOM

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

Not yet recruiting Phase 3 Last updated 11 August 2025
What this trial tests

Phase 3 trial testing Maintenance in Wet Age-related Macular Degeneration (wAMD) in 180 participants. Not yet recruiting.

Timeline
20 August 2025
Primary endpoint
1 February 2027
1 February 2027

Quick facts

Lead sponsorClinique de Retine de l'est
PhasePhase 3
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment180
Start date20 August 2025
Primary completion1 February 2027
Estimated completion1 February 2027
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

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.

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.

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Other trials of Maintenance

Trials testing the same drug.

Other recruiting trials for Wet Age-related Macular Degeneration (wAMD)

Currently open trials in the same condition.

Verify against primary sources

Data sources for this page

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