NCT00538538

Subretinal Lucentis for Hemorrhagic Age-related Macular Degeneration (AMD)

Use of Subretinal Ranibizumab (Lucentis) in the Management of Submacular Hemorrhage in Neovascular Age-Related Macular Degeneration (AMD)

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Corewell Health East · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

Visual outcomes of the eye with large subretinal hemorrhages (bleeding under the retina) due to Age-Related Macular Degeneration (AMD) are poor. The Submacular Surgery Trial (SST) showed that no statistically significant improvement in vision resulted from surgical removal of the layer of abnormal blood vessels causing the bleeding. However, placement of a gas bubble into the gel of the eye along with removal of the blood has shown some success. However, this does not treat the underlying condition of the AMD. Intravitreal injections (into the gel of the eye) of a drug called Lucentis has been shown to be highly effective in the treatment of AMD, yet its penetration through areas of thick blood caused by subretinal hemorrhage is not known. This study is proposing to treat the AMD causing the subretinal hemorrhage with a vitrectomy (surgery involving removing the gel inside the eye, and membrane layers of the eye) followed by Lucentis placed between the layers of the retina and then with or without a gas bubble. In order to determine if the the subretinal Lucentis alone is beneficial, 5 of the 10 patients enrolled will get a gas bubble and the other 5 will not.

Detailed description

Subjects will be followed for a period of 12 months. Based on photographs and other testing procedures, if it is deemed in the subject's best interest, the subject may receive monthly injections of Lucentis to help treat the AMD.

Conditions

• Retinal Hemorrhage
• Macular Degeneration

Interventions

Type	Name	Description
DRUG	vitrectomy with subretinal lucentis	A gas bubble will be placed in the eye after the gel has been removed.
DRUG	vitrectomy with subretinal lucentis	These patients will have a vitrectomy where the gel is removed but will not receive the gas bubble.

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2007-10-02
• Last updated: 2016-08-08

Locations

1 site across 1 country: United States