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Completed

NCT Number: NCT01958918

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

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.

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Key information

Conditions

Neovascular Age-related Macular Degeneration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Feldkirch, Austria

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About this study

Patients attended 14 scheduled study visits during 12 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ranibizumab

Drug

0.5 mg intravitreal injection

Other names: Lucentis®

aflibercept

Drug

2 mg intravitreal injection

Other names: Eylea®

Primary outcomes

  1. Mean of the Absolute Values of CSRT Difference Month 3 to Month 6

    Time frame: 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 outcomes

  1. Total Best Corrected Visual Acuity (BCVA) Score Measured in ETDRS Letters at Month 12

    Time frame: 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

  2. IREST at Month 12

    Time frame: Month 12

    Number of incorrectly read words (IREST) was assessed using International Reading Speed Texts (IResT) and measured in words per minute.

  3. National Eye Institute Visual Functioning Questionnaire Composite Score (VFQ-25) at Month 12

    Time frame: 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.

  4. Correlations Between CSRT Fluctuation (Month 3 to 6) and Functional Outcomes at Month 12 (Full Analysis Set)

    Time frame: Month 3 to Month 6, Month 12

    Correlation coefficient calculated based on Pearson's correlation between each corresponding parameter and CSRT stability.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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)

Acronym: SALT

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Oct 9, 2013
Registry last updated
Mar 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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