Safety Study of High-Dose Ranibizumab for Polypoidal Choroidal Vasculopathy
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 25 - Any |
| Updated: | 4/2/2016 |
| Start Date: | November 2010 |
| End Date: | February 2013 |
| Contact: | Jacqueline F Shen |
| Email: | jshen@retinahi.com |
| Phone: | (808) 380-8060 |
Investigator Sponsored Trial of Polypoidal Choroidal Vasculopathy (PCV) Evaluation Assessing High-Dose Ranibizumab (2.0mg) Prospectively
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.
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.
for one year.
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
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