This is an open label study to evaluate 2.0 mg intravitreal aflibercept injection administered in subject who have active choroidal neovascularization due to Age Related Macular Degeneration (AMD).
Twenty (20) consented participant who meet the inclusion criteria will be enrolled to be followed for 48 weeks. All subjects will receive 2.0 mg intravitreal aflibercept injections with three initial monthly doses, and mandatory doses at Weeks 16, 24, 32, and 40. Dosing at monthly intervals is allowed if needed in the opinion of the investigator based on presence of fluid on Optical Coherence Tomography (OCT) and/or a decrease in visual acuity of greater than or equal to 5 letters from the best previous visit. Only one eye will be enrolled in the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Intravitreal Aflibercept injection 2.0 mg dosed every 4 weeks (monthly) for the first 3 months followed by 2.0 mg (0.05mL) via intravitreal injection once every 8 weeks (2 months). Dosing at monthly intervals is allowed if needed in the opinion of the investigator based on presence of fluid on OCT and/or a decrease in visual acuity of 5 letters or more from the best previous visit.
The Retina Institute
St Louis, Missouri, United States
The Retina Institute
St Louis, Missouri, United States
Valley Retina Institute
McAllen, Texas, United States
Resolution time of intraretinal cysts and sub retinal fluid on OCT
Time frame: 12 months
Mean change in OCT central foveal thickness
Time frame: 12 months
The percentage of subjects with no fluid on OCT
Time frame: 12 months
The percentage of subjects who lose less than 15 letters of visual acuity
Time frame: 12 months
The percentage of subjects who gain greater than or equal to 15 letters of visual acuity
Time frame: 12 months
Mean change in visual acuity
Time frame: 12 months
Mean change in macular volume
Time frame: 12 months
Quantitative change in area (microns) from baseline in choroidal neovascular lesion characteristics/size as measured by ICG/FA/Fundus photos
Time frame: 12 months
Mean number of injections of 2.0 mg intravitreal aflibercept injection
Time frame: 12 months
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