RecruitingPhase 3ACTRN12614000497606

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.


Sponsor

Australian National University (ANU)

Enrollment

60 participants

Start Date

Jan 29, 2015

Study Type

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

Sex: Both males and femalesMin Age: 50 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing two approved eye injections — ranibizumab (Lucentis) and aflibercept (Eylea) — for treating wet age-related macular degeneration (AMD), a condition that causes blurry or lost central vision in older adults. Researchers also want to test a new vision-testing tool called multifocal objective pupil perimetry (mfPOP) to see how well it tracks disease progress and treatment effects compared to standard testing methods. You may be eligible if: - You are 50 years of age or older - You have recently been diagnosed with wet AMD in one eye and have not yet been treated - You have some usable vision in the affected eye (at least 20 letters on an eye chart) You may NOT be eligible if: - Your other eye is currently receiving anti-VEGF injections for AMD or another condition - You have had anti-VEGF therapy in either eye within the last 6 months - You have ever had anti-VEGF treatment in the eye being studied - You have diabetes or any other disease known to affect the retina - You have glaucoma or another nerve condition in the study eye - You have had cataract surgery in the past 6 months, or are likely to need it within 2 years - You are highly short-sighted (myopic refraction of -6 diopters or worse) - You have a known allergy to ranibizumab or aflibercept Talk to your doctor about whether this trial might be right for you.

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

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)

The Canberra Hospital - Garran

ACT,SA, Australia

Flinders Medical Centre - Bedford Park

ACT,SA, Australia

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ACTRN12614000497606