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Evaluation of Safety and Efficacy of Once Monthly Ranibizumab Injections in Chinese Patients With Wet Age Related Macular Degeneration (AMD) Patients (EXTEND II)

Primary Purpose

Age Related Macular Degeneration

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
ranibizumab 0.5 mg
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age Related Macular Degeneration focused on measuring AMD, Ranibizumab

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female Chinese patients 50 years of age or greater.
  • Patients with primary or recurrent subfoveal CNV secondary to AMD.
  • Patients who have a BCVA score from 73 to 24 characters in the study eye.

Exclusion Criteria:

  • Active, or history of, ocular inflammation or infection in the study eye within the last 30 days.
  • Uncontrolled glaucoma in the study eye.

Other protocol-defined inclusion/exclusion criteria may apply.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigational Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

To evaluate efficacy of ranibizumab 0.5 mg by mean change in best-corrected visual acuity (BCVA) from Baseline to Month 4 as assessed with early treatment of diabetic retinopathy study (ETDRS) like charts at a distance of 4 meters.

Secondary Outcome Measures

To evaluate the effects of ranibizumab 0.5 mg on the change in BCVA from Baseline to Month 12.
To evaluate effects of ranibizumab 0.5 mg on retinal structure at Month 4 and Month 12 as assessed by fundus photography, fluorescein angiography, and optical coherence tomography.
To evaluate safety of ranibizumab 0.5 mg by rates of adverse events/SAEs, ophthalmic exams, tonometry, and changes in laboratory values/vital signs at Months 4 and 12.

Full Information

First Posted
January 16, 2009
Last Updated
November 16, 2016
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00826371
Brief Title
Evaluation of Safety and Efficacy of Once Monthly Ranibizumab Injections in Chinese Patients With Wet Age Related Macular Degeneration (AMD) Patients
Acronym
EXTEND II
Official Title
An Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Ranibizumab (0.5 mg) in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration Over 12 Months
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
The purpose of the study is to provide efficacy and safety data for monthly ranibizumab 0.5 mg intravitreal injections in Chinese patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). The study results will support the regulatory submission in China to make ranibizumab available for clinical use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Macular Degeneration
Keywords
AMD, Ranibizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ranibizumab 0.5 mg
Primary Outcome Measure Information:
Title
To evaluate efficacy of ranibizumab 0.5 mg by mean change in best-corrected visual acuity (BCVA) from Baseline to Month 4 as assessed with early treatment of diabetic retinopathy study (ETDRS) like charts at a distance of 4 meters.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
To evaluate the effects of ranibizumab 0.5 mg on the change in BCVA from Baseline to Month 12.
Time Frame
12 Months
Title
To evaluate effects of ranibizumab 0.5 mg on retinal structure at Month 4 and Month 12 as assessed by fundus photography, fluorescein angiography, and optical coherence tomography.
Time Frame
12 Months
Title
To evaluate safety of ranibizumab 0.5 mg by rates of adverse events/SAEs, ophthalmic exams, tonometry, and changes in laboratory values/vital signs at Months 4 and 12.
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female Chinese patients 50 years of age or greater. Patients with primary or recurrent subfoveal CNV secondary to AMD. Patients who have a BCVA score from 73 to 24 characters in the study eye. Exclusion Criteria: Active, or history of, ocular inflammation or infection in the study eye within the last 30 days. Uncontrolled glaucoma in the study eye. Other protocol-defined inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Novartis Investigative Site
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Novartis Investigational Site
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Novartis Investigative Site
City
Guangzhou
ZIP/Postal Code
510060
Country
China
Facility Name
Novartis Investigative Site
City
Shanghai
ZIP/Postal Code
200031
Country
China
Facility Name
Novartis Investigative Site
City
Shanghai
ZIP/Postal Code
200080
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
25012926
Citation
Zhao J, Li X, Tang S, Xu G, Xu X, Zhang F, Zhang M, Shamsazar J, Pilz S, Nieweg A. EXTEND II: an open-label phase III multicentre study to evaluate efficacy and safety of ranibizumab in Chinese patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration. BioDrugs. 2014 Dec;28(6):527-36. doi: 10.1007/s40259-014-0106-1.
Results Reference
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Evaluation of Safety and Efficacy of Once Monthly Ranibizumab Injections in Chinese Patients With Wet Age Related Macular Degeneration (AMD) Patients

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