NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Polypoidal Chorodial Vasculopathy
Date of first enrollment	10/06/2013
Target sample size	320
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : Ranibizumab INN of investigational material : Therapeutic category code : 131 Agents for ophthalmic use Dosage and Administration for Investigational material : 0.5mg Intravitreal injection control material(s) Generic name etc : Veteporfin PDT INN of investigational material : Therapeutic category code : 131 Agents for ophthalmic use Dosage and Administration for Investigational material : Infusion of 30mL veteporfin in 5%dectrose solution followed by 83sec of laser light (50J/cm2; 600mW/cm2; 689nm)

Outcome(s)

Primary Outcome

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 Outcome

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

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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
Exclude 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