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

Study Overview
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Brief Summary
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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
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Patients attended 14 scheduled study visits during 12 months.

Official Title
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A 12-month, Phase IV, Randomized, Open Label, Multicenter Study to Compare Efficacy of 0.5 mg Ranibizumab Pro re Nata (PRN) Versus 2 mg Aflibercept Bimonthly Intravitreal Injections on Retinal Thickness Stability Till Month 6 of Treatment and Explore Functional Outcomes up to Month 12 in Patients With Neovascular (Wet) Age-related Macular Degeneration (AMD)

Conditions
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Neovascular Age-related Macular Degeneration

Intervention / Treatment
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* Drug: Ranibizumab
* Drug: Aflibercept


Participation Criteria
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Eligibility Criteria
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Key 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ranibizumab<br>1 intravitreal injection monthly until maximum stable BCVA with retreatment based on BCVA loss and/or SD-OCT signs of wet AMD disease activity | Drug: Ranibizumab<br>* 0.5 mg intravitreal injection<br>* Other names: Lucentis®;|
| Active Comparator: Aflibercept<br>1 intravitreal injection monthly for the first 3 months, followed by 1 intravitreal injection every 2 months | Drug: Aflibercept<br>* 2 mg intravitreal injection<br>* Other names: Eylea®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean of the Absolute Values of CSRT Difference Month 3 to 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. | Month 3, Month 4, Month 5, Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Best Corrected Visual Acuity (BCVA) Score Measured in ETDRS Letters at 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 | Month 12 | 
| IREST at Month 12 | Number of incorrectly read words (IREST) was assessed using International Reading Speed Texts (IResT) and measured in words per minute. | Month 12 | 
| National Eye Institute Visual Functioning Questionnaire Composite Score (VFQ-25) at 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. | Month 12 | 
| Correlations Between CSRT Fluctuation (Month 3 to 6) and Functional Outcomes at Month 12 (Full Analysis Set) | Correlation coefficient calculated based on Pearson's correlation between each corresponding parameter and CSRT stability. | Month 3 to Month 6, Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wet age-related macular degeneration (AMD), ranibizumab, aflibercept, Best Corrected Visual Acuity (BCVA), Spectral Domain Optical Coherence Tomography (SD-OCT)