NCT00749021

Ranibizumab for Treating Submacular Vascularized Pigment Epithelial Detachments

A Phase I Study to Evaluate the Efficacy and Safety of Treating Subfoveal Pigment Epithelial Detachment Associated With Choroidal Neovascularization With Anti-vascular Endothelial Growth Factor Fragment, Ranibizumab.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Clement K. Chan · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, open-label study. 40 patients will be followed for a period of 12 months. All consented and enrolled patients will receive either 0.5mg or 2.0mg of intravitreal ranibizumab injection.

Conditions

• Retinal Pigment Epithelial Detachment

Interventions

Type	Name	Description
DRUG	Ranibizumab	0.5 mg of intravitreal ranibizumab monthly for 12 months
DRUG	Ranibizumab	0.5 mg intravitreal injection of ranibizumab for 4 months followed by PRN dosing
DRUG	Ranibizumab	2.0mg of intravitreal ranibizumab monthly for 12 months
DRUG	Ranibizumab	2.0mg of intravitreal injection of Ranibizumab for 4 months followed by PRN dosing

Timeline

• Start date: 2008-09-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2008-09-09
• Last updated: 2012-10-05

Locations

3 sites across 1 country: United States