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Not yet recruiting NCT07129239

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

Phase III Interventional Wet Age-related Macular Degeneration (wAMD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Maintenance.
Who it may be relevant to
Registry conditions: Wet Age-related Macular Degeneration (wAMD). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Other Maintenance
    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

Primary outcome measures

  • Central Retinal Thickness (CRT) [Time frame: 6 and 12 month]
Secondary outcome measures (7)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Clinique de Retine de L'Est — Montreal

Identifiers

NCT: NCT07129239 · 23002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗