Clinical Trial: Subretinal Lucentis for Hemorrhagic Age-related Macular Degeneration (AMD)
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Use of Subretinal Ranibizumab (Lucentis) in the Management of Submacular Hemorrhage in Neovascular Age-Related Macular Degeneration (AMD)
Brief 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 Summary: 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.
Sponsor: William Beaumont Hospitals
Current Primary Outcome: 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. [ Time Frame: 12 months ]
Original Primary Outcome: To investigate the safety and tolerability of vitrectomy combined with a single dose of subretinal Ranibizumb (0.5mg) in patients with submacular hemorrhage and choroidal neovascular membranes secondary to AMD. [ Time Frame: 12 months ]
Current Secondary Outcome: Mean change in visual acuity, angiographic area, retinal thickness by optical coherence tomography, mean number of retreatments required by 12 months. [ Time Frame: 12 months ]
Original Secondary Outcome: Mean change in visual acuity, angiographic area, retinal thickness by optical coherence tomography, amplitude and latency of multifocal electroretinogram at Month 12 [ Time Frame: 12 months ]
Information By: William Beaumont Hospitals
Dates:
Date Received: October 1, 2007
Date Started: September 2007
Date Completion: October 2008
Last Updated: August 4, 2016
Last Verified: August 2016
