Observation of Treatment Patterns With Lucentis® in Real-life Conditions in All Approved Indications

Completed

• Conditions: Neovascular (Wet) Age-related Macular Degeneration
• Interventions: Drug: Lucentis

• Registration Number: NCT04847895
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study is designed as an observational, non-interventional, multicenter, open label, single arm study in patients being treated with Lucentis® for any approved indication included in the local product posology.

Detailed Description

The prospective observation period per patient will be up to 24 months. A minimum of one follow-up visit per year is required in order to maintain patient's participation in the study.

The baseline visit will be used to assess eligibility and collect baseline characteristics information. The follow-up visits will take place at a frequency defined as per investigator's discretion.

The study eye is defined as the first eye treated during the study, the other eye will be considered as the fellow eye. If both eyes are treated at baseline, the right eye will be chosen as the study eye.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-06-01
• Study First Submitted: 2021-03-26
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-12
• Last Update Submitted: 2021-04-12
• Study First Posted: 2021-04-19
• Last Update Posted: 2021-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5500

Inclusion Criteria

• Male or female patients, ≥18 years of age, being treated with Lucentis® for any approved indication in the local Lucentis® SmPC
• Written informed consent

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Exclusion Criteria

• As described in Lucentis® SmPC
• Participation in any other clinical study or NIS with Lucentis® as the investigational drug (such as OCEAN or LUMINOUS)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lucentis	Lucentis	Patients administered Lucentis by prescription

Primary Outcome Measures

Name	Time	Method
mean change in visual acuity	Baseline, Up to month 24	Visual acuity will be measured according to the method used by each participating physician in his/her routine practice. To be able to integrate different visual acuity assessment methods for analysis, visual acuity assessments performed using Snellen or decimal notation will be converted into an Early Treatment Diabetic Retinopathy Study (ETDRS) letter score equivalent.
mean change in central retinal thickness	Baseline, Up to month 24	As central retinal thickness data is optional, this analysis will be performed only if data allow.

Secondary Outcome Measures

Name	Time	Method
Time interval between visits	Up to 24 months	Time interval between visits will be provided
Duration of treatment period	Up to 24 months	Duration of treatment period will be provided
Maximum period of treatment extension	Up to 24 months	Maximum period of treatment extension (where applicable)
Number of retreatments	Up to 24 months	Number of retreatments will be provided
Reasons for retreatment	Up to 24 months	Reasons for retreatment will be provided
Number of treatments	Up to 24 months	Number of treatments will be provided
Number of visits	Up to 24 months	Number of visits will be provided
Time interval between treatments	Up to 24 months	Time interval between treatments will be provided
Monitoring and treatment patterns as a function of health insurances	Up to 24 months	The results from the above derived monitoring and treatment regimen will be stratified for German patients according to the status of insurance (public health insurance or private health insurance).
Monitoring and treatment regimen - Therapy schemes	Up to 24 months	The following therapy schemes are defined: * Fixed scheme (FIX): Planned interval of (control-) visits: "regular" and planned treatment performance: "at each visit"; * Pro Re Nata (PRN): Planned interval of (control-) visits: "regular" and planned treatment performance: "as needed"; * Treat \& Extend (T+E): Planned interval of (control-) visits: "variable" and planned treatment performance: "at each visit"; * Monitor \& Extend (M+E): Planned interval of (control-) visits: "variable" and planned treatment performance: "as needed"; FIX, PRN, T+E and M+E are based on documentation by visit regarding physician's planning and will be applied as overall planned therapy scheme, if no different therapy schemes are documented between patient's visit.; Actual interval of (control-) visits and treatment performance will be derived using the documented visit dates and treatment documentations.
Reasons for choice of treatment regimen	Up to 24 months	Reasons for choice of treatment regimen will be provided. The choice of treatment is described within 5 categories: * Medical reasons; * Compability with organisation of practice/clinic; * Compability with availability of patient; * Patient's request; * Other
Number of treatments with Lucentis® vials and pre-filled syringe	Up to 24 months	Number of treatments with Lucentis® vials and pre-filled syringe will be provided

Trial Locations

Locations (1)

Novartis Investigative Site; 🇨🇭 Zurich, Switzerland