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Safety Study for Treatment of Wet Macular Degeneration Using the TheraSight(TM) Ocular Brachytherapy System

Primary Purpose

Macular Degeneration, Choroidal Neovascularization

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ocular Brachytherapy
Sponsored by
Theragenics Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration focused on measuring macular degeneration, brachytherapy, choroidal neovascularization, retinal degeneration, retinal diseases

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 50 years or older. 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: Prior AMD therapy treatment, including but not limited to laser and photodynamic therapy. 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.

Sites / Locations

  • Theragenics Clinical SiteRecruiting
  • Theragenics Clinical SiteRecruiting
  • Theragenics Clinical SiteRecruiting
  • Theragenics Clinical SiteRecruiting
  • Theragenics Clinical SiteRecruiting
  • Theragenics Clinical SiteRecruiting

Outcomes

Primary Outcome Measures

Incidence of serious adverse events 30 to 270 days after treatment

Secondary Outcome Measures

Serious adverse events occurring 9 months to 3 years after treatment
Reported adverse events occurring at any time after treatment
Feasibility of device use based on physician interviews and ultrasonography
Observation of retinal and angiographic appearance of CNV lesion and best-corrected visual acuity

Full Information

First Posted
December 22, 2004
Last Updated
June 23, 2005
Sponsor
Theragenics Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00100087
Brief Title
Safety Study for Treatment of Wet Macular Degeneration Using the TheraSight(TM) Ocular Brachytherapy System
Official Title
A Safety and Feasibility Study of the TheraSight(TM) Ocular Brachytherapy System for Treatment of Age-Related Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
January 2005
Overall Recruitment Status
Unknown status
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Theragenics Corporation

4. Oversight

5. Study Description

Brief Summary
The study will investigate the safety and feasibility of using the TheraSight(TM) Brachytherapy System for treatment of wet age-related macular degeneration (AMD).
Detailed Description
This is a multi-center randomized study of three doses of radiation (assigned 1:1:1) delivered by the TheraSight(TM) Brachytherapy System in participants with choroidal neovascularization (CNV) secondary to wet (exudative) AMD. Each participant receives a single dose of radiation delivered by one-time only brachytherapy. Participants are followed for three years after the radiation treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration, Choroidal Neovascularization
Keywords
macular degeneration, brachytherapy, choroidal neovascularization, retinal degeneration, retinal diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Ocular Brachytherapy
Primary Outcome Measure Information:
Title
Incidence of serious adverse events 30 to 270 days after treatment
Secondary Outcome Measure Information:
Title
Serious adverse events occurring 9 months to 3 years after treatment
Title
Reported adverse events occurring at any time after treatment
Title
Feasibility of device use based on physician interviews and ultrasonography
Title
Observation of retinal and angiographic appearance of CNV lesion and best-corrected visual acuity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 50 years or older. 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: Prior AMD therapy treatment, including but not limited to laser and photodynamic therapy. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Theragenics Corporation
Phone
1-877-960-1234
Facility Information:
Facility Name
Theragenics Clinical Site
City
Atlanta
State/Province
Georgia
Country
United States
Individual Site Status
Recruiting
Facility Name
Theragenics Clinical Site
City
Augusta
State/Province
Georgia
Country
United States
Individual Site Status
Recruiting
Facility Name
Theragenics Clinical Site
City
Indianapolis
State/Province
Indiana
Country
United States
Individual Site Status
Recruiting
Facility Name
Theragenics Clinical Site
City
Boston
State/Province
Massachusetts
Country
United States
Individual Site Status
Recruiting
Facility Name
Theragenics Clinical Site
City
Newark
State/Province
New Jersey
Country
United States
Individual Site Status
Recruiting
Facility Name
Theragenics Clinical Site
City
Raleigh / Durham
State/Province
North Carolina
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Safety Study for Treatment of Wet Macular Degeneration Using the TheraSight(TM) Ocular Brachytherapy System

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