Macular Degeneration Clinical Trial
Official title:
Use of Subretinal Ranibizumab (Lucentis) in the Management of Submacular Hemorrhage in Neovascular Age-Related Macular Degeneration (AMD)
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.
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. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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