Safety Study of High-Dose Ranibizumab for Polypoidal Choroidal Vasculopathy
Investigator Sponsored Trial of Polypoidal Choroidal Vasculopathy (PCV) Evaluation Assessing High-Dose Ranibizumab (2.0mg) Prospectively
  • Phase

    Phase 1/Phase 2
  • Study Type

  • Status

    Unknown status
  • Intervention/Treatment

    ranibizumab ...
  • Study Participants

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.
Patients will be followed with spectral oct, 4m BCVA, ICG, FA and monthly eye examinations for one year.
Study Started
Nov 30
Primary Completion
Dec 31
Study Completion
Feb 28
Last Update
Nov 25

Drug ranibizumab 2.0mg

Monthly, intravitreal injection 0.05ml

Previously Treated Experimental

With prior anti-vegf therapy, only, no sooner than 30 days prior to enrollment into trial

Treatment-Naive Experimental

Treatment-Naive: no previous treatment for PCV


Inclusion Criteria:

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

Exclusion Criteria:

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
No Results Posted