Efficacy and Safety of Verteporfin Added to Ranibizumab in the Treatment of Symptomatic Macular P… (NCT00674323) | Clinical Trial Compass
CompletedPhase 4
Efficacy and Safety of Verteporfin Added to Ranibizumab in the Treatment of Symptomatic Macular Polypoidal Choroidal Vasculopathy
Hong Kong, Singapore, South Korea61 participantsStarted 2008-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 infl…
What they're measuring
1
Number of Participants With Complete Regression (CR) of Polyps Measured by Indocyanine Green Angiography (ICGA)