NCT00826371

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 22, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Last Updated

November 18, 2016

Status Verified

November 1, 2016

Enrollment Period

1.5 years

First QC Date

January 16, 2009

Last Update Submit

November 16, 2016

Conditions

Age Related Macular Degeneration

Keywords

AMDRanibizumab

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (3)

  • To evaluate the effects of ranibizumab 0.5 mg on the change in BCVA from Baseline to Month 12.

    12 Months

  • 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.

    12 Months

  • 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.

    12 Months

Study Arms (1)

1

EXPERIMENTAL
Drug: ranibizumab 0.5 mg

Interventions

ranibizumab 0.5 mgDRUG
1

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Novartis Investigative Site

Beijing, 100044, China

Location

Novartis Investigative Site

Beijing, 100730, China

Location

Novartis Investigational Site

Chengdu, 610041, China

Location

Novartis Investigative Site

Guangzhou, 510060, China

Location

Novartis Investigative Site

Shanghai, 200031, China

Location

Novartis Investigative Site

Shanghai, 200080, China

Location

Related Publications (1)

  • 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.

    PMID: 25012926RESULT

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 16, 2009

First Posted

January 22, 2009

Study Start

January 1, 2009

Primary Completion

July 1, 2010

Last Updated

November 18, 2016

Record last verified: 2016-11

Locations

CN(6)