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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00826371
First received: January 16, 2009
Last updated: August 26, 2010
Last verified: August 2010
  Purpose

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.


Condition Intervention Phase
Age Related Macular Degeneration
Drug: ranibizumab 0.5 mg
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the effects of ranibizumab 0.5 mg on the change in BCVA from Baseline to Month 12. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 114
Study Start Date: January 2009
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: ranibizumab 0.5 mg

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  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: NCT00826371

Locations
China
Novartis Investigative Site
Beijing, China, 100730
Novartis Investigative Site
Beijing, China, 100044
Novartis Investigational Site
Chengdu, China, 610041
Novartis Investigative Site
Guangzhou, China, 510060
Novartis Investigative Site
Shanghai, China, 200080
Novartis Investigative Site
Shanghai, China, 200031
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00826371     History of Changes
Other Study ID Numbers: CRFB002A2203
Study First Received: January 16, 2009
Last Updated: August 26, 2010
Health Authority: China: Ethics Committee
China: Ministry of Health

Keywords provided by Novartis:
AMD
Ranibizumab

Additional relevant MeSH terms:
Macular Degeneration
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Choroid Diseases
Uveal Diseases
Neovascularization, Pathologic
Metaplasia
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014