Safety Study of High-Dose Ranibizumab for Polypoidal Choroidal Vasculopathy

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Polypoidal Choroidal Vasculopathy

In brief

Monthly, continuous anti-vegf therapy for patients presenting with active polypoidal choroidal vasculopathy. Two arms, treatment naive and previously treated with an FDA approved anti-VEGF therapy, will be randomized and dosed with open label 2.0mg ranibizumab.

Key facts

Study ID

NCT01248117

Run by

Retina Consultants of Hawaii

People needed

20

Starts

2010-11-01

Expected to finish

2013-02-01

Last updated by the study team

2010-11-25

Who can join

Age: 25 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Ability to provide written informed consent and comply with study assessments for the full duration of the study
• 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

You may not qualify if…

• Any history of prior vitrectomy
• 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

Where it is running

• Retina Consultants of Hawaii, Inc — Honolulu, Hawaii, United States (enrolling)
• Retina Consultants of Hawaii — ‘Aiea, Hawaii, United States (enrolling)

Full record on ClinicalTrials.gov

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