NCT00288561

Brief Summary

Ranibizumab is derived from a murine monoclonal anti- vascular endothelial growth factor (VEGF) antibody and can penetrate through the many retinal cell layers following intravitreal injection. The present study is directed towards the assessment of ranibizumab administered on the same day in combination with verteporfin in patients with subfoveal CNV secondary to ARMD

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Nov 2004

Geographic Reach
1 country

1 active site

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

November 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 8, 2006

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

June 19, 2008

Status Verified

June 1, 2008

First QC Date

February 7, 2006

Last Update Submit

June 18, 2008

Conditions

Age-Related Macular Degeneration (ARMD)

Keywords

ARMD, ranibizumab, verteporfin

Interventions

ranibizumabDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients 50 years of age or greater who have provided written informed consent
  • Patients with subfoveal choroidal neovascularization lesions secondary to AMD, either predominantly classic or occult with no classic component
  • Patients who have a BCVA score between 73 and 24 letters, inclusively, in the study eye using ETDRS (approximately 20/40 to 20/320)
  • Willing to return for all scheduled visits

You may not qualify if:

  • \- Patients who have a BCVA of \< 34 letters in both eyes (legally blind is defined as bilateral vision below 20/200 or less than 34 letters)
  • Prior treatment in the study eye with verteporfin, external-beam radiation therapy, subfoveal focal laser photocoagulation, vitrectomy, or transpupillary thermotherapy
  • Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis

Basel, Switzerland

Location

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 Customer Information

    Novartis - Including Sites in Germany

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 7, 2006

First Posted

February 8, 2006

Study Start

November 1, 2004

Study Completion

July 1, 2007

Last Updated

June 19, 2008

Record last verified: 2008-06

Locations

CH(1)