Polypoidal Chorodial Vasculopathy
Conditions
Interventions
Sponsors
Novartis Pharma K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Confirmed diagnosis of symptomatic macular PCV in the study eye A qualifying visoin score at study entry Aqualifying lesion size in the study eye at study entry
Exclusion criteria
Exclusion criteria: Active inflammation or infection in the study eye Uncontrolled intraocular pressure in the study 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in visual acuity from baseline and complete polyp regression assessed by ICGA in the study eye Change from Baseline in in Visual Acuity (Letters) of the Study Eye to Month 12 Complete polyp regression assessed by ICGA at Month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in Visual Acuity of the Study Eye Change from Baseline in Visual Acuity (Letters) of the Study Eye over time [ Time Frame: Baseline to Month 24 complete polyp regression in the Study Eye Occurrence of complete polyp regression in the Study Eye as assessed by ICGA at Months 6 and 24 Presence of leakage in the Study Eye Presence of leakage in the Study Eye based on fluorescein angiography at Months 6, 12 and 24 Change in Central Subfield Retinal Thickness (CSRT) of the Study Eye Change from Baseline in Central Subfield Retinal Thickness (CSRT) of the Study Eye over time Total number of treatments with ranibizumab in the Study Eye and total number of treatments with verteporfin PDT Total number of treatments with ranibizumab in the Study Eye and total number of treatments with verteporfin PDT from baseline to Month 12 and 24 National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) scores National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) scores at baseline, Months 3, 12, and 24, and change from baseline over time Frequency and severity of ocular and non-ocular adverse events over time Frequency and severity of ocular and non-ocular adverse events over time | — |
Outcome results
None listed