None listed
Conditions
Brief 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.
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
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.
Sponsors
Australian National University (ANU)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age>=50 years New diagnosis of unilateral wet AMD requiring treatment with anti-VEGF agents in the opinion of the investigator. Best corrected visual acuity of >=20 letters (6/120)
Exclusion criteria
Wet AMD in the fellow eye already receiving anti-VEGF therapy, or other disease in the fellow eye requiring anti-vegf therapy. (end stage wet amd in the fellow eye is acceptable, as are drusen of any extent). Anti-VEGF therapy in the fellow eye within the last 6 months, or systemically within 6 months. Previous treatment with anti-VEGF agents in the study eye ever. (previous laser greater than 6 months ago is acceptable, but not within 6 months) Haemorrhage greater than 50% of the lesion area. Glaucomatous optic neuropathy or any other optic neuropathy in the study eye Diabetes mellitus or any other disease known to affect retinal function. Presence of disease known to affect pupil movement in response to efferent stimuli, eg posterior synechiae, third nerve lesion, etc. Cataract surgery within the last 6 months. Cataract that is likely to require surgery within 2 years Maculopathy due to other causes * myopic macular degeneration, retinal vein occlusion). * Myopic refraction <=-6 diopters (spherical equivalent). In patients who have had refractive procedures (cataract surgery or refractive surgery), the refraction prior to the procedure is used. If not available, then the presence of fundus features consistent with high myopia (significant periparillary atrophy, posterior staphyloma) will be used as exclusion criteria. * Choroidal neovascularisation due to causes other than AMD (eg pathologic myopia, multifocal choroiditis, angioid streaks, sorsby’s macular dystrophy, previous macular laser, Central serous retinopathy ) An ocular condition that would prevent visual acuity improvement despite resolution of oedema (such as foveal atrophy, sub-foveal fibrosis or optic atrophy) Any condition which would affect follow-up or photographic documentation (e.g. geographical, psycho-social) Patient has a condition or is in a situation that in the investigator’s opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient’s participation in the study. Known allergy to ranibizumab or aflibercept.
Outcome results
None listed