Stopped: This condition can now be managed in the office with an injection of Lucentis.
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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
To investigate the safety and tolerability of vitrectomy combined with a single dose of subretinal Ranibizumab (Lucentis - 0.5 mg) in patients with submacular hemorrhage and choroidal neovascular membranes secondary to AMD.
Timeframe: 12 months