Study of Ranibizumab Administered in Conjunction With Photodynamic Therapy With Verteporfin in Patients With Subfoveal Choroidal Neovascularization and Age-Related Macular Degeneration
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Age-Related Macular Degeneration (ARMD)
Intervention: ranibizumab (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s): Novartis Customer Information, Study Chair, Affiliation: Novartis - Including Sites in Germany
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
Clinical Details
Official title: Open-Label, Multicenter, Phase II Study Assessing the Safety of Ranibizumab Administered in Conjunction With Photodynamic Therapy With Verteporfin in Patients With Occult or Predominately Classic Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (ARMD)
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- - 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
Locations and Contacts
Novartis, Basel, Switzerland
Additional Information
Starting date: November 2004
Last updated: June 18, 2008
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