Safety Study of High-Dose Ranibizumab for Polypoidal Choroidal Vasculopathy

• Status: Unknown status
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

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, will be randomized and dosed with open label 2.0mg ranibizumab.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Retina Consultants of Hawaii
• Collaborator: Genentech, Inc.
• Treatments: Ranibizumab

Criteria

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