NCT01469156

Safety Study of 2.0mg Lucentis to Treat Polypoidal Choroidal Vasculopathy

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Southeast Retina Center, Georgia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

Twenty eyes will be randomized will receive 3 consecutive monthly intravitreal 1.0 or 2.0 mg/0.5mg (3:1 ratio) Ranibizumab injection with the first injection occuring at Day 0 and second and third injection occuring at month 1 and month 2 respectively. Retreatment with intravitreal Ranibizumab or other therapies will be at the investigators discretion but guidelines for recommended retreatment.

Conditions

• Polypoidal Choroidal Vasculopathy

Interventions

Type	Name	Description
DRUG	ranibizumab 0.5 or 2.0 mg/0.05 cc	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.

Timeline

• Start date: 2011-09-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2011-11-10
• Last updated: 2022-12-12
• Results posted: 2022-12-12

Locations

1 site across 1 country: United States