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

Clinique de Retine de l'est

Status and phase: Not yet enrolling; Phase 3

Conditions: Wet Age-related Macular Degeneration (wAMD)

Treatments: Other: Maintenance

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07129239

23002

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

180 participants in 2 patient groups

Loading interval group

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Other: Maintenance