Status:

COMPLETED

Study of Ranibizumab Administered in Conjunction With Photodynamic Therapy With Verteporfin in Patients With Subfoveal Choroidal Neovascularization and Age-Related Macular Degeneration

Lead Sponsor:

Novartis

Conditions:

Age-Related Macular Degeneration (ARMD)

Eligibility:

All Genders

50+ years

Phase:

PHASE2

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 pr...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • \- 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.)
  • Other protocol-defined inclusion/exclusion criteria may apply

Key Trial Info

Start Date :

November 1 2004

Trial Type :

INTERVENTIONAL

End Date :

July 1 2007

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00288561

Start Date

November 1 2004

End Date

July 1 2007

Last Update

June 19 2008

Active Locations (1)

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1

Novartis

Basel, Switzerland