A Phase 1 interventional study of vitrectomy with subretinal lucentis and vitrectomy with subretinal lucentis in Retinal Hemorrhage and Macular Degeneration, sponsored by William Beaumont Hospitals. Withdrawn at 1 site in United States. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-08.
Sponsored by William Beaumont Hospitals · Phase 1, Interventional, and Treatment
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.
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
Browse Macular Degeneration studies →William Beaumont Hospitals is the lead sponsor of 111 studies on the registry; none are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 30 (100%) have results posted.
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Exclusion Criteria:
Does not receive Gas bubble
Drug: vitrectomy with subretinal lucentis
Does receive gas bubble
Drug: vitrectomy with subretinal lucentis
A gas bubble will be placed in the eye after the gel has been removed.
These patients will have a vitrectomy where the gel is removed but will not receive the gas bubble.
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
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
This study is withdrawn, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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William Beaumont Hospitals