CompletedPhase 4

Visual Outcome in Patients With Symptomatic Macular Polypoidal Choroidal Vasculopathy (PCV) Treated With Either Ranibizumab as Monotherapy or Combined With Verteporfin Photodynamic Therapy (vPDT)

Hong Kong, Japan321 participantsStarted 2013-08-07

Plain-language 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 symptomatic macular polypoidal choroidal vasculopathy (PCV). The results of this study provided long-term safety and efficacy data used to generate further guidance on the management of patients with PCV.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

What they're measuring

Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 - Study Eye

Timeframe: Baseline, Month 12

Number of Patients With Complete Polyp Regression From Baseline at Month 12 - Study Eye

Timeframe: Baseline, Month 12

Trial details

NCT IDNCT01846273

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-03-11

Results submitted2018-02-27

View on ClinicalTrials.gov More Age-related Macular Degeneration trials