This is a prospective, single-blind, randomized study to evaluate intravitreal aflibercept injection (IAI) versus sham as prophylaxis against conversion to neovascular age-related macular degeneration (AMD) in "high-risk" subjects.
128 subjects will be enrolled in the trial and randomized in a 1:1 ratio to receive either IAI every three months for 24 months or sham injections. Enrollment will be stratified in order to ensure a balance between the two treatment groups for subjects who were diagnosed with exudative AMD within the past two years versus those diagnosed more than two years prior to Baseline. Study assessments will be conducted at required visits every three months and include manifest refraction and ETDRS visual acuity testing, slit lamp exam and dilated fundus exam, spectral-domain optical coherence tomography (SD-OCT) using Avanti device, and OCT angiography using Avanti AngioVueTM, and fluorescein angiography. Fundus photography will also be performed at Baseline, Month 12 and Month 24 visits. In the event of conversion to neovascular AMD in the study eye at any point during the study, the Investigator will treat the subject with IAI at a frequency per his/her discretion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
128
Intravitreal aflibercept injection
Sham injection
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States
NJ Retina
Edison, New Jersey, United States
Retina Consultants of Houston
Houston, Texas, United States
Percentage of Subjects Converting to Exudative AMD at 24 Months.
Percentage of subjects converting to exudative AMD at 24 months as confirmed by independent masked reading center.
Time frame: 24 months
Percentage of Patients Converted to Exudative AMD Who Had Exudative AMD in Fellow Eye ≤ 2 Years at Baseline.
Percentage of patients converted to exudative AMD in study eye who had exudative AMD in fellow eye ≤ 2 years at Baseline.
Time frame: up to Month 24
Percentage of Patient Converted to Exudative AMD Based on Presence of Nonexudative CNV.
Percentage of patients converted to exudative AMD compared to all patients with presence of nonexudative CNV in the study eye at Month 24, as confirmed by independent reading center evaluation of OCT angiography images.
Time frame: up to Month 24
Mean Change in Best-corrected Visual Acuity at 24 Months Compared to Baseline
Mean change in best-corrected visual acuity (BCVA) at 24 months compared to baseline according to ETDRS protocol. BCVA is evaluated by counting the number of letters correctly read by the patient on an ETDRS eye chart. A higher value indicates that the patient read more letter correctly which indicates a better outcome.
Time frame: 24 months
Mean Change in Growth of Geographic Atrophy.
Mean change in growth of geographic atrophy from baseline to Month 24.
Time frame: 24 months
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