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

January 14, 2014 updated by: Novartis Pharmaceuticals

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

277

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria, 1090
        • Novartis Investigative Site
    • Upper Austria
      • Linz, Upper Austria, Austria, 4021
        • Novartis Investigative Site
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 3N9
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Novartis Investigative Site
  • France
      • Bordeaux Cedex, France, F-33076
        • Novartis Investigative Site
      • Dijon, France, 21033
        • Novartis Investigative Site
      • Paris, France, 75015
        • Novartis Investigative Site
      • Reims, France, 51092
        • Novartis Investigative Site
      • Toulouse, France, 31059
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 13353
        • Novartis Investigative Site
      • Bonn, Germany, 53127
        • Novartis Investigative Site
      • Freiburg, Germany, 79106
        • Novartis Investigative Site
      • Hamburg, Germany, 20246
        • Novartis Investigative Site
      • Koeln, Germany, 50924
        • Novartis Investigative Site
      • Muenster, Germany, 48149
        • Novartis Investigative Site
      • Muenster, Germany, 48145
        • Novartis Investigative Site
      • München, Germany, 81675
        • Novartis Investigative Site
      • Nuernberg, Germany, 90491
        • Novartis Investigative Site
      • Regensburg, Germany, 93053
        • Novartis Investigative Site
  • Hong Kong
      • Hongkong, Hong Kong
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary, 1083
        • Novartis Investigative Site
      • Debrecen, Hungary, 4004
        • Novartis Investigative Site
  • India
      • Bangalore, India, 560010
        • Novartis Investigative Site
      • New Delhi, India, 110 029
        • Novartis Investigative Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400031
        • Novartis Investigative Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600006
        • Novartis Investigative Site
      • Madurai, Tamil Nadu, India, 625020
        • Novartis Investigative Site
  • Italy
    • BA
      • Bari, BA, Italy, 70124
        • Novartis Investigative Site
    • FI
      • Firenze, FI, Italy, 50134
        • Novartis Investigative Site
    • MI
      • Milano, MI, Italy, 20132
        • Novartis Investigative Site
      • Milano, MI, Italy, 20157
        • Novartis Investigative Site
    • UD
      • Udine, UD, Italy, 33100
        • Novartis Investigative Site
  • Japan
      • Kyoto, Japan, 606-8507
        • Novartis Investigative Site
    • Aichi
      • Nagoya-city, Aichi, Japan, 467-8602
        • Novartis Investigative Site
      • Nagoya-city, Aichi, Japan, 466-8560
        • Novartis Investigative Site
    • Fukuoka
      • Fukuoka-city, Fukuoka, Japan, 812-8582
        • Novartis Investigative Site
    • Fukushima
      • Fukushima-city, Fukushima, Japan, 960-1295
        • Novartis Investigative Site
    • Hokkaido
      • Sapporo-city, Hokkaido, Japan, 060-8648
        • Novartis Investigative Site
    • Kagawa
      • Kita-gun, Kagawa, Japan, 761-0793
        • Novartis Investigative Site
    • Nagano
      • Matsumoto, Nagano, Japan, 390-8621
        • Novartis Investigative Site
    • Osaka
      • Hirakata-city, Osaka, Japan, 573-1191
        • Novartis Investigative Site
      • Suita-city, Osaka, Japan, 565-0871
        • Novartis Investigative Site
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8655
        • Novartis Investigative Site
      • Bunkyo-ku, Tokyo, Japan, 113-8519
        • Novartis Investigative Site
      • Chiyoda-ku, Tokyo, Japan, 101-8309
        • Novartis Investigative Site
      • Mitaka-city, Tokyo, Japan, 181-8611
        • Novartis Investigative Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 738-736
        • Novartis Investigative Site
    • Korea
      • Seoul, Korea, Korea, Republic of, 120-752
        • Novartis Investigative Site
      • Seoul, Korea, Korea, Republic of, 110 744
        • Novartis Investigative Site
      • Seoul, Korea, Korea, Republic of, 135-710
        • Novartis Investigative Site
  • Latvia
      • Riga, Latvia, 1002
        • Novartis Investigative Site
  • Lithuania
      • Kaunas, Lithuania, LT-50009
        • Novartis Investigative Site
      • Vilnius, Lithuania, LT-08661
        • Novartis Investigative Site
  • Poland
      • Bielsko-Biala, Poland, 43-300
        • Novartis Investigative Site
  • Portugal
      • Coimbra, Portugal, 3000-075
        • Novartis Investigative Site
      • Porto, Portugal, 4200-319
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 308433
        • Novartis Investigative Site
      • Singapore, Singapore, 168751
        • Novartis Investigative Site
      • Singapore, Singapore, 768825
        • Novartis Investigative Site
  • Slovakia
      • Bratislava, Slovakia, 82606
        • Novartis Investigative Site
    • Slovak Republic
      • Banska Bystrica, Slovak Republic, Slovakia, 975 17
        • Novartis Investigative Site
  • Spain
    • Castilla y Leon
      • Valladolid, Castilla y Leon, Spain, 47011
        • Novartis Investigative Site
    • Cataluña
      • Hospitalet de Llobregat, Cataluña, Spain, 08907
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Alicante, Comunidad Valenciana, Spain, 03016
        • Novartis Investigative Site
    • Pais Vasco
      • Bilbao, Pais Vasco, Spain, 48006
        • Novartis Investigative Site
  • Switzerland
      • Bern, Switzerland, 3010
        • Novartis Investigative Site
      • Genève, Switzerland, 1204
        • Novartis Investigative Site
      • Lausanne, Switzerland, 1007
        • Novartis Investigative Site
  • Turkey
      • Ankara, Turkey, 06100
        • Novartis Investigative Site
      • Ankara, Turkey, 06490
        • Novartis Investigative Site
      • Etlik / Ankara, Turkey, 06018
        • Novartis Investigative Site
  • United Kingdom
      • Belfast, United Kingdom, BT12 6BA
        • Novartis Investigative Site
      • Bristol, United Kingdom, BS1 2LX
        • Novartis Investigative Site
      • Wolverhampton, United Kingdom, WV10 0QP
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ranibizumab driven by disease activity
Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
Drug: Ranibizumab
0.5 mg ranibizumab intravitreal injection
Drug: Sham Ranibizumab
Empty vial to mimic the intravitreal injection
Drug: Sham verteporfin PDT
Sham vPDT intravenous infusion of dextrose 5% solution followed by light application (PDT).
Experimental: Ranibizumab driven by stabilization criteria
Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity
Drug: Ranibizumab
0.5 mg ranibizumab intravitreal injection
Drug: Sham Ranibizumab
Empty vial to mimic the intravitreal injection
Drug: Sham verteporfin PDT
Sham vPDT intravenous infusion of dextrose 5% solution followed by light application (PDT).
Active Comparator: Verteporfin PDT
Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
Drug: Ranibizumab
0.5 mg ranibizumab intravitreal injection
Drug: Sham Ranibizumab
Empty vial to mimic the intravitreal injection
Drug: Sham verteporfin PDT
Sham vPDT intravenous infusion of dextrose 5% solution followed by light application (PDT).
Drug: Verteporfin PDT
Verteporfin (6 mg/m2) intravenous infusion
Other Names:
  • vPDT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Change From Baseline to Month 1 Through Month 3 on Visual Acuity of the Study Eye
Time Frame: Baseline, Month 1 through Month 3
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Change From Baseline to Month 6 in Visual Acuity of the Study Eye
Time Frame: Baseline and Month 6
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
Average Change From Baseline to Month 1 Through Month 12 in Visual Acuity of the Study Eye
Time Frame: Baseline and Month 1 through Month 12
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
Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 3
Time Frame: 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
Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 6 and Month 12
Time Frame: Months 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 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
Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 3
Time Frame: 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
Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 6 and 12
Time Frame: Months 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
Change From Baseline in Central Retinal Thickness of the Study Eye Over Time
Time Frame: Baseline, Month 3, Month 6 and Month 12
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
Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye
Time Frame: Baseline and Month 12
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
Number of Ranibizumab Injections Received Prior to Month 3
Time Frame: Day 1 and 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
Number of Ranibizumab Injections Received by Patients Randomized to the Ranibizumab Groups, by Period
Time Frame: Day 1 prior to month 6 and prior to month 12
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
Number of Ranibizumab Injections Received by Patients Randomized to vPDT With Ranibizumab From Month 3 by Period
Time Frame: Month 3 up to month 12
Number of ranibizumab injections received by patients randomized to the vPDT with ranibizumab groups, by period.
Month 3 up to month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

October 6, 2010

First Submitted That Met QC Criteria

October 7, 2010

First Posted (Estimate)

October 8, 2010

Study Record Updates

Last Update Posted (Estimate)

February 10, 2014

Last Update Submitted That Met QC Criteria

January 14, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRFB002F2301
  • 2010-021662-30 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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