Efficacy and Safety of Ranibizumab in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia

Pathological Myopia Clinical Trial

Official title:

A 12 Month, Phase III, Randomized, Double-masked, Multicenter, Active-controlled Study to Evaluate the Efficacy and Safety of Two Different Dosing Regimens of 0.5 mg Ranibizumab vs. Verteporfin PDT in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01217944
• Other study ID #: CRFB002F2301
• Secondary ID: 2010-021662-30
• Status: Completed
• Phase: Phase 3
• First received: October 6, 2010
• Last updated: January 14, 2014
• Start date: October 2010
• Est. completion date: August 2012

Study information

• Verified date: January 2014
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustria: AGES-PharmMed LCMCanada: Health CanadaFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyHong Kong: Department of HealthIndia: Ministry of HealthItaly: The Italian Medicines AgencyJapan: Pharmaceuticals and Medical Devices AgencyKorea: Food and Drug AdministrationLatvia: State Agency of MedicinesLithuania: State Medicine Control Agency - Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPortugal: National Pharmacy and Medicines InstituteSingapore: Health Sciences AuthoritySlovakia: State Institute for Drug ControlSpain: AGEMED (Spanish Agency of Medicinal Products and Health Products)Switzerland: SwissmedicTurkey: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

This study is designed to evaluate the efficacy and safety of two different dosing regimens of 0.5 mg ranibizumab given as intravitreal injection in comparison to verteporfin PDT in patients with visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia (PM).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 277
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Visual impairment due to choroidal neovascularization (CNV) secondary to PM

• Best corrected visual acuity (BCVA) in the study eye > 24 and < 78 Early Treatment Diabetic Retinopathy Study (ETDRS) letters

• High myopia (> -6D), anterior-posterior elongation > 26 mm; posterior changes compatible with the pathologic myopia

• Either lesion types in the study eye: subfoveal, juxtafoveal, extrafoveal

Exclusion Criteria:

• Patients with uncontrolled systemic or ocular diseases

• Blood pressure > 150/90 mmHg

• History of pan-retinal, focal/grid laser photocoagulation or intraocular treatment with any anti-VEGF or vPDT in the study eye

• Intravitreal treatment with corticosteroids or intraocular surgery within last 3 months in the study eye

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Myopia
• Myopia, Degenerative
• Neovascularization, Pathologic
• Pathological Myopia

Intervention

Drug:
• Ranibizumab
0.5 mg ranibizumab intravitreal injection
• Verteporfin PDT
Verteporfin (6 mg/m2) intravenous infusion
• Sham Ranibizumab
Empty vial to mimic the intravitreal injection
• Sham verteporfin PDT
Sham vPDT intravenous infusion of dextrose 5% solution followed by light application (PDT).

Locations

Country	Name	City	State
Austria	Novartis Investigative Site	Linz	Upper Austria
Austria	Novartis Investigative Site	Wien
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Vancouver	British Columbia
France	Novartis Investigative Site	Bordeaux Cedex
France	Novartis Investigative Site	Dijon
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site	Reims
France	Novartis Investigative Site	Toulouse
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Freiburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Koeln
Germany	Novartis Investigative Site	Muenster
Germany	Novartis Investigative Site	Muenster
Germany	Novartis Investigative Site	München
Germany	Novartis Investigative Site	Nuernberg
Germany	Novartis Investigative Site	Regensburg
Hong Kong	Novartis Investigative Site	Hongkong
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Debrecen
India	Novartis Investigative Site	Bangalore
India	Novartis Investigative Site	Chennai	Tamil Nadu
India	Novartis Investigative Site	Madurai	Tamil Nadu
India	Novartis Investigative Site	Mumbai	Maharashtra
India	Novartis Investigative Site	New Delhi
Italy	Novartis Investigative Site	Bari	BA
Italy	Novartis Investigative Site	Firenze	FI
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Udine	UD
Japan	Novartis Investigative Site	Bunkyo-ku	Tokyo
Japan	Novartis Investigative Site	Bunkyo-ku	Tokyo
Japan	Novartis Investigative Site	Chiyoda-ku	Tokyo
Japan	Novartis Investigative Site	Fukuoka-city	Fukuoka
Japan	Novartis Investigative Site	Fukushima-city	Fukushima
Japan	Novartis Investigative Site	Hirakata-city	Osaka
Japan	Novartis Investigative Site	Kita-gun	Kagawa
Japan	Novartis Investigative Site	Kyoto
Japan	Novartis Investigative Site	Matsumoto	Nagano
Japan	Novartis Investigative Site	Mitaka-city	Tokyo
Japan	Novartis Investigative Site	Nagoya-city	Aichi
Japan	Novartis Investigative Site	Nagoya-city	Aichi
Japan	Novartis Investigative Site	Sapporo-city	Hokkaido
Japan	Novartis Investigative Site	Suita-city	Osaka
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul
Latvia	Novartis Investigative Site	Riga
Lithuania	Novartis Investigative Site	Kaunas
Lithuania	Novartis Investigative Site	Vilnius
Poland	Novartis Investigative Site	Bielsko-Biala
Portugal	Novartis Investigative Site	Coimbra
Portugal	Novartis Investigative Site	Porto
Singapore	Novartis Investigative Site	Singapore
Singapore	Novartis Investigative Site	Singapore
Singapore	Novartis Investigative Site	Singapore
Slovakia	Novartis Investigative Site	Banska Bystrica	Slovak Republic
Slovakia	Novartis Investigative Site	Bratislava
Spain	Novartis Investigative Site	Alicante	Comunidad Valenciana
Spain	Novartis Investigative Site	Bilbao	Pais Vasco
Spain	Novartis Investigative Site	Hospitalet de Llobregat	Cataluña
Spain	Novartis Investigative Site	Valladolid	Castilla y Leon
Switzerland	Novartis Investigative Site	Bern
Switzerland	Novartis Investigative Site	Genève
Switzerland	Novartis Investigative Site	Lausanne
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Etlik / Ankara
United Kingdom	Novartis Investigative Site	Belfast
United Kingdom	Novartis Investigative Site	Bristol
United Kingdom	Novartis Investigative Site	Wolverhampton

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Austria,  Canada,  France,  Germany,  Hong Kong,  Hungary,  India,  Italy,  Japan,  Korea, Republic of,  Latvia,  Lithuania,  Poland,  Portugal,  Singapore,  Slovakia,  Spain,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Change From Baseline to Month 1 Through Month 3 on Visual Acuity of the Study Eye	The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and compared to the average from month 1 to month 3.	Baseline, Month 1 through Month 3	No
Secondary	Average Change From Baseline to Month 6 in Visual Acuity of the Study Eye	The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and month 6. The overall BCVA score was calculated using the BCVA worksheet.	Baseline and Month 6	No
Secondary	Average Change From Baseline to Month 1 Through Month 12 in Visual Acuity of the Study Eye	The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and Month 1 through 12	Baseline and Month 1 through Month 12	No
Secondary	Percentage of Patients With Best Corrected Visual Acuity (BCVA) =10 and =15 Letters Gain or Reach 84 Letters at Month 3	BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained more than 10 or more than 15 of visual acuity at month 3.	Month 3	No
Secondary	Percentage of Patients With Best Corrected Visual Acuity (BCVA) =10 and =15 Letters Gain or Reach 84 Letters at Month 6 and Month 12	BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained more than 10 or more than 15 letters of visual acuity at month 6 and month 12.	Months 6 and 12	No
Secondary	Percentage of Patients With Best Corrected Visual Acuity (BCVA) =10 and =15 Letter Loss at Month 3	BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. A decreased score indicates worsening in acuity. This outcome assessed the percentage of participants who lost more than 10 or more than 15 of visual acuity at month 3.	Month 3	No
Secondary	Percentage of Patients With Best Corrected Visual Acuity (BCVA) =10 and =15 Letter Loss at Month 6 and 12	BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. A decreased score indicates worsening in acuity. This outcome assessed the percentage of participants who lost more than 10 or more than 15 of visual acuity at month 6 and 12.	Months 6 and 12	No
Secondary	Change From Baseline in Central Retinal Thickness of the Study Eye Over Time	Retinal thickness was measured by Central Reading Center using patient's Optical Coherence Tomography (OCT) images provided by investigators.	Baseline, Month 3, Month 6 and Month 12	No
Secondary	Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye	CNV leakage assessment plus other choroid and retinal disorders were assessed by Central Reading Center using patient's fluorescein angiography and color fundus photography images provided by investigators.	Baseline and Month 12	No
Secondary	Number of Ranibizumab Injections Received Prior to Month 3	In order to describe exposure to the study drug the number of ejections was evaluated	Day 1 and prior to month 3	Yes
Secondary	Number of Ranibizumab Injections Received by Patients Randomized to the Ranibizumab Groups, by Period	Number of ranibizumab injections received by patients randomized to the ranibizumab groups, by period	Day 1 prior to month 6 and prior to month 12	Yes
Secondary	Number of Ranibizumab Injections Received by Patients Randomized to vPDT With Ranibizumab From Month 3 by Period	Number of ranibizumab injections received by patients randomized to the vPDT with ranibizumab groups, by period.	Month 3 up to month 12	Yes