CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
ranibizumab 0.5 or 2.0 mg/0.05 ccdrug
Likely dose
ranibizumab 0.5 or 2.0 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/NCT01469156
NCT01469156Phase 2Completed
CompareCT.gov

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

Southeast Retina Center, Georgia·interventional·Posted Nov 10, 2011·Updated Dec 12, 2022

In Brief

A Phase 2 clinical trial evaluating ranibizumab 0.5 or 2.0 mg/0.05 cc for Polypoidal Choroidal Vasculopathy. Completed, enrolled 20 participants across 1 site.

Detailed Summary

This Phase I/II study will investigate the safety and tolerability of intravitreally administered 0.5mg and 1.0 or 2.0mg Ranibizumab in three monthly doses followed by a 9 month period of criteria-based, as-needed retreatment and 12 month of drug safety follow up in subjects with exudative polypoidal choroidal vasculopathy (PCV) for a total of 24 months.

Study Details

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

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 10, 2011
Enrollment StartSep 1, 2011
Primary CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 14.6 years ago

Interventions

ranibizumab 0.5 or 2.0 mg/0.05 ccdrug

ranibizumab (3:1 ratio of 2mg:0.5 mg ranibizumab) administered in three initial monthly doses followed by a 9 month period of criteria-based, as-needed retreatment and 12 month off drug safety follow up.