Status:
COMPLETED
Visual Outcome in Patients With Symptomatic Macular Polypoidal Choroidal Vasculopathy (PCV) Treated With Either Ranibizumab as Monotherapy or Combined With Verteporfin Photodynamic Therapy (vPDT)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Age-related Macular Degeneration
Polypoidal Choroidal Vasculopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study compared the effect of ranibizumab administered as monotherapy versus ranibizumab administered in combination with verteporfin photodynamic therapy (PDT) on visual acuity in patients with s...
Detailed Description
Patients were randomized to the study in 2 treatment groups: ranibizumab + vPDT combination therapy, and ranibizumab monotherapy. Based on the results of the primary analysis at Month 12, patients sti...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of symptomatic macular PCV in the study eye
- A qualifying vision score at study entry
- A qualifying lesion size in the study eye at study entry
Exclusion
- Active inflammation or infection in the study eye
- Uncontrolled intraocular pressure in the stuy eye
- Ocular condition in the study eye which may impact vision and confound study outcomes
- Prior treatment of the study eye with anti-VEGF therapy, verteporfin PDT, other laser and surgical interventions, intraocular corticosteroids
Key Trial Info
Start Date :
August 7 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 2 2017
Estimated Enrollment :
321 Patients enrolled
Trial Details
Trial ID
NCT01846273
Start Date
August 7 2013
End Date
March 2 2017
Last Update
June 7 2019
Active Locations (41)
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1
Novartis Investigative Site
Hong Kong, Hong Kong
2
Novartis Investigative Site
Nagoya, Aichi-ken, Japan, 462-0825
3
Novartis Investigative Site
Nagoya, Aichi-ken, Japan, 466 8560
4
Novartis Investigative Site
Fukuoka, Fukuoka, Japan, 812-8582