Safety Study for Treatment of Wet Macular Degeneration Using the TheraSight(TM) Ocular Brachytherapy System
NCT ID: NCT00100087
Last Updated: 2005-06-24
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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UNKNOWN
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2004-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Ocular Brachytherapy
Eligibility Criteria
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Inclusion Criteria
* Active primary or recurrent subfoveal CNV secondary to AMD with minimally classic or occult lesion, where an active lesion is defined as one or more of the following:
a) An increase \> 10% in lesion size (greatest linear dimension) on screening fluorescein angiography compared to previous fluorescein angiography no more than 180 days preceding screening visit
* b) Subretinal hemorrhage associated with CNV within 90 days of screening visit.
* c) Visual acuity loss \> 1 Snellen line in screening visual acuity compared to previous visual acuity no more than 180 days preceding screening
* Lesion \< 6 mm greatest linear dimension (GLD)
* Submacular blood must comprise less than 75% of the total lesion
* Subretinal fibrosis must comprise less than 25% of the total lesion
* Study eye best-corrected vision of 20/100 or poorer measured on an ETDRS chart (\< 48 letters correct)
* Fellow eye best-corrected vision that is at least one line better on an ETDRS chart than the best-corrected vision of the study eye
* HbA1c \< 6%
* Read and signed informed consent
Exclusion Criteria
* Current or planned participation in the next 180 days in other experimental trials involving treatment of neovascular AMD in the study eye, ocular devices, or trials involving treatment for ocular conditions other than AMD.
* Prior ophthalmic surgery for the study eye other than cataract extraction and/or capsulotomy. A minimum interval of 180 days must elapse between cataract extraction or capsulotomy and study enrollment.
* Likely need for cataract surgery in study eye during the 180 days following TheraSight(TM) System treatment.
* Presence of other eye diseases that could compromise visual acuity in the study eye or that, in the clinical judgment of the evaluating study ophthalmologist, might create special risk for the study participant.
* CNV due to other causes such as ocular histoplasmosis or pathologic myopia.
* Endstage fibrotic disciform lesions.
* Diabetes requiring diet modification, or medication, or insulin.
* Current history of malignancy (except participants having basal cell carcinoma that was treated successfully, or other malignancy operated on or treated and in remission for five years prior to inclusion in the trial).
* Hypertensive retinopathy.
* Major cardiovascular or cerebrovascular event within the last year; examples include congestive heart failure, myocardial infarction, and stroke.
* Inability to complete follow-up.
* Allergy to fluorescein dye.
* Previous radiation to the study eye.
* Pregnancy at time of surgical procedure.
50 Years
ALL
No
Sponsors
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Theragenics Corporation
INDUSTRY
Locations
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Theragenics Clinical Site
Atlanta, Georgia, United States
Theragenics Clinical Site
Augusta, Georgia, United States
Theragenics Clinical Site
Indianapolis, Indiana, United States
Theragenics Clinical Site
Boston, Massachusetts, United States
Theragenics Clinical Site
Newark, New Jersey, United States
Theragenics Clinical Site
Raleigh / Durham, North Carolina, United States
Countries
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Central Contacts
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Theragenics Corporation
Role: CONTACT
Phone: 1-877-960-1234
Other Identifiers
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NPD-07-01
Identifier Type: -
Identifier Source: org_study_id