The RAAMP study. Ranibizumab versus aflibercept for age-related macular degeneration, using multifocal objective pupil perimetry.
A randomised trial evaluating the ability of multifocal objective pupil perimetry to track macular function in treatment-naive eyes with wet Age-Related Macular Degeneration (AMD), treated with either aflibercept or ranibizumab.
Australian National University (ANU)
60 participants
Jan 29, 2015
Interventional
Conditions
Summary
Age-related macular degeneration (AMD) is a very common problem in the elderly. The treatment is given by intraocular injection, and there are two TGA approved medications (Lucentis and Eylea) which are in common use in Australia for AMD. Both have been shown to be equivalent. The investigators have shown in previous studies that a novel tool for visual testing known as multifocal objective pupil perimetry (mfPOP) is sensitive at picking up the loss of retinal function observed with AMD, and also the recovery in function following Lucentis therapy. The investigators plan to randomise 60 patients with new onset wet AMD to either Lucentis or Eylea therapy and to manage them according to standard, accepted clinical practice. They will be followed using both the standard testing and also mfPOP to see if mfPOP is an effective tool at monitoring disease progress on therapy, and also to see if mfPOP can detect any subtle differences between the two medications.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Intravitreal Aflibercept 2mg. This will be given monthly for three months, then patients will be reviewed monthly for a further 22 months, and injections will be given using a pre-defined pro-re-nata (prn) protocol based on clinical activity (on OCT and fundoscopy), with no pre-mandated injections. The visit schedule will be organised for each patient on enrollment, and adherence to the protocol will be closely monitored with scheduled reminders prior to each visit and recall within 1 week if visits are missed. At each monthly visit multifocal objective pupil perimetry (mfPOP) will be performed. This 10 minute non-invasive test uses subtle pupil responses to visual stimuli as an objective measure of the sensitivity of visual function in that region of the visual field.
Locations(2)
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ACTRN12614000497606