CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
ranibizumab 0.5 or 0.3 mg/0.05 ccdrug
Likely dose
ranibizumab 0.5 or 0.3 mg/0.05 ccfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00837330
NCT00837330Phase 2Completed

Treatment of Polypoidal Choroidal Vasculopathy With Ranibizumab(Lucentis): A Phase I/II Safety Study.

Southeast Retina Center, Georgia·interventional·Posted Feb 5, 2009·Updated Apr 16, 2019

In Brief

A Phase 2 clinical trial evaluating ranibizumab 0.5 or 0.3 mg/0.05 cc for Polypoidal Choroidal Vasculopathy. Completed, enrolled 20 participants across 1 site.

Detailed Summary

This Phase I/II safety study is designed to investigate the safety and efficacy of ranibizumab (Lucentis) in the treatment of polypoidal choroidal vasculopathy (PCV), a potentially blinding eye disease that involves the growth of tiny, abnormal blood vessels under the retina. These abnormal blood vessels can bleed or leak fluid, causing disruption of normal retinal function and vision loss. Ranibizumab is a drug that is FDA-approved for the treatment of wet age-related macular degeneration (AMD) and is injected directly into the eye. Given the efficacy of ranibizumab in the treatment of wet AMD, and the postulated similarity between the disease mechanisms involved in both wet AMD and PCV, we believe ranibizumab will have a beneficial effect on visual function in patients with PCV.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsGenentech, Inc.

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 5, 2009
Enrollment StartMay 1, 2006
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 17.4 years ago

Interventions

ranibizumab 0.5 or 0.3 mg/0.05 ccdrug

ranibizumab 0.5 or 0.3 mg/0.05 cc administered intraocularly on a monthly basis for 3 months, followed by monthly examination with the option of further ranibizumab treatment or other therapies at the discretion of the treating physician