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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01217944
First received: October 6, 2010
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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).


Condition Intervention Phase
Pathological Myopia
Drug: Ranibizumab
Drug: Verteporfin PDT
Drug: Sham Ranibizumab
Drug: Sham verteporfin PDT
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Average Change From Baseline to Month 6 in Visual Acuity of the Study Eye [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 3 [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Central Retinal Thickness of the Study Eye Over Time [ Time Frame: Baseline, Month 3, Month 6 and Month 12 ] [ Designated as safety issue: No ]
    Retinal thickness was measured by Central Reading Center using patient's Optical Coherence Tomography (OCT) images provided by investigators.

  • Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
    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.

  • Number of Ranibizumab Injections Received Prior to Month 3 [ Time Frame: Day 1 and prior to month 3 ] [ Designated as safety issue: Yes ]
    In order to describe exposure to the study drug the number of ejections was evaluated

  • 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 ] [ Designated as safety issue: Yes ]
    Number of ranibizumab injections received by patients randomized to the ranibizumab groups, by period

  • 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 ] [ Designated as safety issue: Yes ]
    Number of ranibizumab injections received by patients randomized to the vPDT with ranibizumab groups, by period.


Enrollment: 277
Study Start Date: October 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Verteporfin PDT
Verteporfin (6 mg/m2) intravenous infusion
Other Name: vPDT
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01217944

  Show 74 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01217944     History of Changes
Other Study ID Numbers: CRFB002F2301, 2010-021662-30
Study First Received: October 6, 2010
Results First Received: August 14, 2013
Last Updated: January 14, 2014
Health Authority: United States: Food and Drug Administration
Austria: AGES-PharmMed LCM
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Hong Kong: Department of Health
India: Ministry of Health
Italy: The Italian Medicines Agency
Japan: Pharmaceuticals and Medical Devices Agency
Korea: Food and Drug Administration
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Pharmacy and Medicines Institute
Singapore: Health Sciences Authority
Slovakia: State Institute for Drug Control
Spain: AGEMED (Spanish Agency of Medicinal Products and Health Products)
Switzerland: Swissmedic
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Pathologic myopia
PM
choroidal neovascularization
CNV
ranibizumab
verteporfin PDT

Additional relevant MeSH terms:
Choroidal Neovascularization
Myopia
Neovascularization, Pathologic
Myopia, Degenerative
Choroid Diseases
Uveal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Refractive Errors
Verteporfin
Photosensitizing Agents
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 16, 2014