Status:
COMPLETED
Intravitreal Ranibizumab in Retinal Pigment Epithelial Detachments
Lead Sponsor:
University Hospital Muenster
Collaborating Sponsors:
Novartis
Conditions:
Pigment Epithelial Detachment
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to demonstrate the efficacy of ranibizumab in patients with retinal pigment epithelial detachment secondary to age-related macular degeneration (AMD).
Detailed Description
Pigment epithelial detachments (PED) secondary to age-related macular degeneration (AMD) have been excluded from practically all study populations of ranibizumab studies so far. PED represents a speci...
Eligibility Criteria
Inclusion
- patients with age-related macular degeneration and serous pigment epithelial detachment as determined by fluorescein and indocyanine green angiography and optical coherence tomography (OCT)
- patients who have a best-corrected visual acuity (BCVA) score between 73 and 24 ETDRS letters
- patients with pigment epithelial detachment (PED) ≥ 200 µm as determined by OCT
- male or female patients 50 years of age or greater
- patients willing and able to comply with all study procedures
Exclusion
- patients with best-corrected visual acuity (BCVA) \< 24 or \>73 letters in the study eye
- patients previously treated by intravitreal injections of steroids or anti-VEGF agents, or patients previously treated by Verteporfin photodynamic therapy or focal laser photocoagulation
- history of uncontrolled glaucoma in the study eye
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00976222
Start Date
December 1 2008
End Date
December 1 2015
Last Update
September 29 2017
Active Locations (2)
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1
University Hospital Muenchen
München, Germany, 80336
2
University Hospital Muenster
Münster, Germany, 48149