ACTRN12614000497606RecruitingPhase 3
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)0 sites60 target enrollmentStarted: May 12, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Diagnosis
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 50 Years to o limit (—)
- Sex
- All
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.
Investigators
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