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

Neovascular Age-related Macular Degeneration Clinical Trial

— SALT  

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01958918
• Other study ID #: CRFB002ADE23
• Status: Completed
• Phase: Phase 4
• Start date: October 23, 2013
• Est. completion date: May 29, 2017

Study information

• Verified date: December 2018
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Patients attended 14 scheduled study visits during 12 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 712
• Est. completion date: May 29, 2017
• Est. primary completion date: November 22, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• Ranibizumab
0.5 mg intravitreal injection
• Aflibercept
2 mg intravitreal injection

Locations

Country	Name	City	State
Austria	Novartis Investigative Site	Feldkirch
Austria	Novartis Investigative Site	Graz
Austria	Novartis Investigative Site	Linz
Austria	Novartis Investigative Site	Salzburg
Austria	Novartis Investigative Site	Vienna
Austria	Novartis Investigative Site	Vienna
Belgium	Novartis Investigative Site	Laeken
Belgium	Novartis Investigative Site	Leuven
Denmark	Novartis Investigative Site	Glostrup
Denmark	Novartis Investigative Site	Roskilde
France	Novartis Investigative Site	Creteil
France	Novartis Investigative Site	Dijon
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site	Paris cedex 10
France	Novartis Investigative Site	Paris, Cedex 12
Germany	Novartis Investigative Site	Bad Rothenfelde
Germany	Novartis Investigative Site	Bayreuth
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Bremen
Germany	Novartis Investigative Site	Chemnitz
Germany	Novartis Investigative Site	Darmstadt
Germany	Novartis Investigative Site	Duesseldorf
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Freiburg
Germany	Novartis Investigative Site	Glauchau
Germany	Novartis Investigative Site	Gottingen
Germany	Novartis Investigative Site	Hagen
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Homburg
Germany	Novartis Investigative Site	Kiel
Germany	Novartis Investigative Site	Koeln
Germany	Novartis Investigative Site	Koeln
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Mainz
Germany	Novartis Investigative Site	Marburg
Germany	Novartis Investigative Site	Muelheim
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Muenster
Germany	Novartis Investigative Site	Muenster
Germany	Novartis Investigative Site	Regensburg	Bavaria
Germany	Novartis Investigative Site	Siegburg
Germany	Novartis Investigative Site	Sulzbach
Germany	Novartis Investigative Site	Tübingen
Germany	Novartis Investigative Site	Ulm
Germany	Novartis Investigative Site	Wolfsburg
Germany	Novartis Investigative Site	Wurzburg
Netherlands	Novartis Investigative Site	Amsterdam
Netherlands	Novartis Investigative Site	Den Bosch
Netherlands	Novartis Investigative Site	Nijmegen
Norway	Novartis Investigative Site	Arendal
Norway	Novartis Investigative Site	Oslo
Portugal	Novartis Investigative Site	Braga
Portugal	Novartis Investigative Site	Coimbra
Portugal	Novartis Investigative Site	Coimbra
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Porto
Portugal	Novartis Investigative Site	Porto
Portugal	Novartis Investigative Site	Vila Franca de Xira
Portugal	Novartis Investigative Site	Vila Nova de Gaia
Sweden	Novartis Investigative Site	Stockholm
Sweden	Novartis Investigative Site	Vasteras
Switzerland	Novartis Investigative Site	Bern
Switzerland	Novartis Investigative Site	Fribourg
Switzerland	Novartis Investigative Site	Genève

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Austria,  Belgium,  Denmark,  France,  Germany,  Netherlands,  Norway,  Portugal,  Sweden,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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