NCT00363168

Ranibizumab in Hemorrhagic Choroidal Neovascularization Trial

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This research is being done to look at the effects of an experimental drug, ranibizumab, on a condition called "predominantly hemorrhagic subfoveal choroidal neovascularization (CNV)" due to wet age-related macular degeneration. A predominantly hemorrhagic CNV lesion is diagnosed when at least 50% of the choroidal neovascular lesion is occupied by blood under the retina. We want to find out if injections of ranibizumab into the eye will help patients with this condition.

Detailed description

This study is a randomized, interventional case series. A total of 10 patients, seen in the Retina Division of the Wilmer Eye Institute, will be enrolled. Subjects will be randomized to either 0.3 mg or 0.5 mg intravitreal injections of ranibizumab, which will be performed monthly for 3 doses. Further monthly injections are at the discretion of the examiner, and may be withheld if there is lack of continued improvement (defined as lack of improvement of at least 5 letters on an eye chart compared with 2 previous consecutive visits or lack of decrease of the retinal center point thickness of at least 50 microns compared with 2 previous consecutive visits) or complete success (defined as visual acuity of 20/20 or better or retinal center point thickness \<225 microns).

Conditions

• Choroidal Neovascularization

Interventions

Type	Name	Description
DRUG	Ranibizumab	0.3 mg/0.05 ml dose
DRUG	Ranibizumab	0.5 mg/0.05 ml dose

Timeline

• Start date: 2006-08-01
• Primary completion: 2008-06-01
• Completion: 2009-05-01
• First posted: 2006-08-15
• Last updated: 2012-10-19
• Results posted: 2012-10-19

Locations

1 site across 1 country: United States