Macular Edema Clinical Trial
Official title:
Intravitreal Aflibercept Injection for Symptomatic Macular Edema From Retinal Artery Macroaneurysms
Phase 1, non-randomized, open label, noncomparative trial to study the effect of intravitreal injection of aflibercept on eyes with symptomatic macular edema from retinal artery macroaneurysms.
Baseline evaluation will consist of measurement of best-corrected ETDRS visual acuity,
complete eye exam, including IOP measurement, color photos and intravenous fluorescein
angiography, spectral domain OCT and vitals. Patients meeting eligibility criteria will be
treated with an intravitreal injection of 2.0 mg aflibercept under usual aseptic precautions.
Follow up visits will be on Day 7, 30, 60, 90, 120, 150 and 180. At each follow-up visit,
best-corrected ETDRS visual acuity, IOP measurement and central foveal thickness (CFT) by
SDOCT will be obtained. Color photos and IVFA will be performed at month 3 and 6 visits.
Retreatment shall be performed no sooner than two months after previous injection for one or
more the following criteria 1. CFT >310 microns 2. Intraretinal or subretinal fluid on SDOCT
3. Increase in CFT by 50 or more microns from the lowest value observed after intravitreal
aflibercept injection 4. Decrease in vision by 5 or more letters frpm the previous visit
associated with OCT evidence of macular edema. 5. Appearance of new hemorrhage on color
photographs.
Final follow-up will be at six months. Data collected will include, change in ETDRS visual
acuity from the baseline, change in CFT, number of injections, number of eyes completely dry
by SDOCT, and number of eyes with a thrombosed RAM by IVFA.
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