Subretinal Lucentis for Hemorrhagic Age-related Macular Degeneration (AMD)
NCT ID: NCT00538538
Last Updated: 2016-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2007-09-30
2008-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
Does not receive Gas bubble
vitrectomy with subretinal lucentis
These patients will have a vitrectomy where the gel is removed but will not receive the gas bubble.
B
Does receive gas bubble
vitrectomy with subretinal lucentis
A gas bubble will be placed in the eye after the gel has been removed.
Interventions
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vitrectomy with subretinal lucentis
A gas bubble will be placed in the eye after the gel has been removed.
vitrectomy with subretinal lucentis
These patients will have a vitrectomy where the gel is removed but will not receive the gas bubble.
Eligibility Criteria
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Inclusion Criteria
* Vision 20/200 or worse
* AMD with submacular hemorrhage
* Hemorrhage more than 25% of the lesion
* Fibrosis or scar not more than 25% of the entire lesion
* Hemorrhage less than 3 months old
* Vision loss occuring within 3 months
Exclusion Criteria
* Participating in any other clinical trial
* Prior treatment for AMD
* Other medical conditions causing compromised vision
* Intraocular eye surgery within the previous 12 months
* Inability to obtain necessary eye photographs
* Systemic use of anti-VEGF agents
* Allergy to fluorescein dye
* Unable to complete all study visits
* Glaucoma filtering surgery
* Use of 2 or more treatments for glaucoma
* Lack of lens in the eye or absence of a posterior capsule
50 Years
ALL
Yes
Sponsors
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William Beaumont Hospitals
OTHER
Responsible Party
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Associated Retinal Consultants, P.C.
Principal Investigators
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Tarek Hassan, MD
Role: PRINCIPAL_INVESTIGATOR
Associated Retinal Consultants/William Beaumont Hosp.
Locations
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William Beaumont Hospital
Royal Oak, Michigan, United States
Countries
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Other Identifiers
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HIC 2007-073
Identifier Type: -
Identifier Source: org_study_id
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