Clinical trial NCT00674323: Efficacy and Safety of Verteporfin Added to Ranibizumab in the Treatment of Symptomatic Macular Polypoidal Choroidal Vasculopathy
Official title: A Multicentre, Randomized, Double Masked, Exploratory, Indocyanine Green Angiography (ICGA) Guided Study of 6 Months Duration to Compare the Safety and Effect on Polyp Regression of Verteporfin Photodynamic Therapy (PDT) Alone or Added to Ranibizumab in Patients With Symptomatic Macular Polypoidal Choroidal Vasculopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Polypoidal Choroidal Vasculopathy
Keywords: Polypoidal choroidal vasculopathy
PCV
Age-related macular degeneration (AMD) variant
vision
polyps
indocyanine green angiography
verteporfin
ranibizumab
photodynamic therapy
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-05-07
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare the efficacy of ranibizumab and verteporfin PDT combination treatment and verteporfin PDT monotherapy vs.ranibizumab monotherapy alone in achieving complete regression of polyps in patients with symptomatic macular polypoidal choroidal vasculopathy.


Eligibility criteria: Inclusion Criteria:

* Patients must give written informed consent before any assessment is performed.
* Male or Female patients ≥18 yrs of age
* Patients willing and able to comply with all study procedures

Inclusion criteria for study eye:

* BCVA letter score between 73-24 (approximately 20/40 to 20/320 Snellen equivalent) using ETDRS visual acuity chart measured at 4 meters
* PCV diagnosis confirmed by Central Reading Center
* Greatest Linear Dimension (GLD) of the total lesion area \< 5400 µm (\~9 Macular Photocoagulation Study Disc Areas)

Exclusion Criteria:

* Women of child-bearing potential who are not using one or more reliable contraception methods
* Pregnant or nursing (lactating) women
* History of hypersensitivity or allergy to fluorescein or indocyanine green (ICG), clinically significant drug allergy or known hypersensitivity to therapeutic or diagnostic protein products, or to any of the study drugs or their components
* Patient with history of porphyria
* Systemic medications known to be toxic to the lens, retina, or optic nerve
* History of which might affect the interpretation of the results of the study, or renders the patient at high risk from treatment complications
* Use of other investigational drugs within 30 days of randomization

Exclusion criteria for study eye:

* Concomitant conditions/diseases:
* Presence of angioid streaks, macular fibrosis, presumed ocular histoplasmosis syndrome, pathologic myopia (-8 Diopters or more)
* Active ocular inflammation or infection
* Uncontrolled glaucoma
* Ocular disorders that may confound interpretation of study results

Prior Ocular treatment:

* Prior Verteporfin PDT, external-beam radiation, laser photocoagulation, macular surgery, or transpupillary thermotherapy
* Prior local treatment with Pegaptanib, Ranibizumab, Bevacizumab or other anti-angiogenic compound or any investigational treatment in both eyes or systemic use of bevacizumab within 90 days prior to randomization
* History of intraocular surgery including pars plana vitrectomy and intraocular hemorrhage displacement is not allowed with the exception of uncomplicated cataract surgery that is allowed within 60 days prior to screening
* Ocular conditions that required chronic concomitant therapy within 90 days prior to randomization with topical, ocular, or systemically administered corticosteroids or any herbal medication known to contain steroid-like components

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Number of Participants With Complete Regression (CR) of Polyps Measured by Indocyanine Green Angiography (ICGA)
timeFrame: Month 6
Secondary outcomes:
measure: Number of Participants With at Least One Complete Polyp Regression During 6 Months Assessed by ICGA
timeFrame: Baseline through end of study (6 months)
measure: Mean Change From Baseline in Central Retinal Thickness Measured by Optic Coherence Tomography (OCT)
timeFrame: Baseline and Month 6
measure: Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) of the Study Eye at Month 6
timeFrame: Baseline and Month 6
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References:
citation: Tan CS, Ngo WK, Chen JP, Tan NW, Lim TH; EVEREST Study Group. EVEREST study report 2: imaging and grading protocol, and baseline characteristics of a randomised controlled trial of polypoidal choroidal vasculopathy. Br J Ophthalmol. 2015 May;99(5):624-8. doi: 10.1136/bjophthalmol-2014-305674. Epub 2015 Mar 10.
citation: Koh A, Lee WK, Chen LJ, Chen SJ, Hashad Y, Kim H, Lai TY, Pilz S, Ruamviboonsuk P, Tokaji E, Weisberger A, Lim TH. EVEREST study: efficacy and safety of verteporfin photodynamic therapy in combination with ranibizumab or alone versus ranibizumab monotherapy in patients with symptomatic macular polypoidal choroidal vasculopathy. Retina. 2012 Sep;32(8):1453-64. doi: 10.1097/IAE.0b013e31824f91e8.