Efficacy of Ranibizumab Prn Treatment Compared to Aflibercept Bimonthly Intravitreal Injections on Retinal Thickness Stability in Patients With Wet AMD

Phase 4

Completed

Brief Summary: The purpose of this study was to compare the efficacy of 0.5 mg ranibizumab versus 2 mg aflibercept bimonthly intravitreal injections on retinal thickness stability.

Detailed Description: Patients attended 14 scheduled study visits during 12 months.

Recruitment & Eligibility

Inclusion Criteria

Visual impairment predominantly due to neovascular AMD Active
Newly diagnosed, untreated, angiographically documented choroidal neovascularization (CNV) lesion

Key

Exclusion Criteria

Stroke or myocardial infarction less than 3 Months prior to study entry
Active injection or inflammation of either eye at the time of study entry
Any type of systemic disease (or received treatment for it), including any medical condition (controlled or uncontrolled) that were to be expected to progress, recur, or change to an extent which could bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk

Arm && Interventions

Group	Intervention	Description
Ranibizumab	Ranibizumab	1 intravitreal injection monthly until maximum stable BCVA with retreatment based on BCVA loss and/or SD-OCT signs of wet AMD disease activity
Aflibercept	Aflibercept	1 intravitreal injection monthly for the first 3 months, followed by 1 intravitreal injection every 2 months

Primary Outcome Measures

Name	Time	Method
Mean of the Absolute Values of CSRT Difference Month 3 to Month 6	Month 3, Month 4, Month 5, Month 6	The thickness of the retina was measured by Spectral Domain Optical Coherence Topography (SD-OCT). The mean of the absolute values of the CSRT difference between Month 3 and 4, Month 4 and 5, and Month 5 and 6 was calculated (ie, CSRT fluctuation). A lower average CSRT fluctuation demonstrates greater retinal stability. One eye (study eye) contributed to the analysis.

Secondary Outcome Measures

Name	Time	Method
Total Best Corrected Visual Acuity (BCVA) Score Measured in ETDRS Letters at Month 12	Month 12	Visual acuity was assessed in a sitting position with refraction using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. A higher score indicates better visual acuity. ETDRS scale ranges from 0-100 letters. A score of 65 to 70 letters represents a low to moderate visual acuity
IREST at Month 12	Month 12	Number of incorrectly read words (IREST) was assessed using International Reading Speed Texts (IResT) and measured in words per minute.
National Eye Institute Visual Functioning Questionnaire Composite Score (VFQ-25) at Month 12	Month 12	Vision-related quality of life was assessed by the patient using the National Eye Institute Visual Function Questionnaire. The scores of 12 subscales (general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision) were added together for a total (composite) score, which ranged from 0 to 100. A higher score indicates poorer function.
Correlations Between CSRT Fluctuation (Month 3 to 6) and Functional Outcomes at Month 12 (Full Analysis Set)	Month 3 to Month 6, Month 12	Correlation coefficient calculated based on Pearson's correlation between each corresponding parameter and CSRT stability.