Status:
UNKNOWN
Safety Study of High-Dose Ranibizumab for Polypoidal Choroidal Vasculopathy
Lead Sponsor:
Retina Consultants of Hawaii
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Polypoidal Choroidal Vasculopathy
Eligibility:
All Genders
25+ years
Phase:
PHASE1
PHASE2
Brief Summary
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, wi...
Detailed Description
Patients will be followed with spectral oct, 4m BCVA, ICG, FA and monthly eye examinations for one year.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01248117
Start Date
November 1 2010
End Date
February 1 2013
Last Update
November 25 2010
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Retina Consultants of Hawaii, Inc
Honolulu, Hawaii, United States, 96819
2
Retina Consultants of Hawaii
‘Aiea, Hawaii, United States, 96701