Safety Study of High-Dose Ranibizumab for Polypoidal Choroidal Vasculopathy
NCT ID: NCT01248117
Last Updated: 2010-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2010-11-30
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Previously Treated
With prior anti-vegf therapy, only, no sooner than 30 days prior to enrollment into trial
ranibizumab 2.0mg
Monthly, intravitreal injection 0.05ml
Treatment-Naive
Treatment-Naive: no previous treatment for PCV
ranibizumab 2.0mg
Monthly, intravitreal injection 0.05ml
Interventions
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ranibizumab 2.0mg
Monthly, intravitreal injection 0.05ml
Eligibility Criteria
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Inclusion Criteria
* Age \>= 25 years
* Polypoidal choroidal vasculopathy as noted on fluorescein and ICG angiography: active leakage, active bleeding or recent decrease in vision
* BVCA using ETDRS of 20/32 to 20/400
Exclusion Criteria
* Any prior treatment with verteporfin PDT in the study eye
* Previous cataract surgery within the preceding 2 months of D0
* Active intraocular inflammation in the study eye
* Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
* A condition, that in the opinion of the investigator, would preclude participation in the study (e.g. unstable medical status including blood pressure, cardiovascular disease)
* Participation in another investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval at the time of study entry.
* Prior anti-VEGF (Macugen, Avastin, Lucentis) in the study eye within 30 days prior to enrollment in this study
* Known allergy to any component in the study drug
* Uncontrolled hypertension: \>180/110
* major surgery within 28 days prior to randomization
* Myocardial infarction, other cardia events requiring hospitalization within 6 months prior to randomization
* Systemic anti-VEGF or pro-VEGF within 3 months of randomization
* Pregnancy or lactation
* History of recurrent significant infections or bacterial infections
25 Years
ALL
Yes
Sponsors
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Genentech, Inc.
INDUSTRY
Retina Consultants of Hawaii
OTHER
Responsible Party
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Retina Consultants of Hawaii
Principal Investigators
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Gregg T Kokame, MD, MMM
Role: PRINCIPAL_INVESTIGATOR
Retina Consultants of Hawaii
Locations
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Retina Consultants of Hawaii, Inc
Honolulu, Hawaii, United States
Retina Consultants of Hawaii
‘Aiea, Hawaii, United States
Countries
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Central Contacts
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Facility Contacts
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Jacqueline F Shen
Role: primary
Jacqueline F Shen
Role: primary
Other Identifiers
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FVF4929s
Identifier Type: -
Identifier Source: org_study_id