NCT00100087

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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2004

Completed
Last Updated

June 24, 2005

Status Verified

January 1, 2005

First QC Date

December 22, 2004

Last Update Submit

June 23, 2005

Conditions

Macular DegenerationChoroidal Neovascularization

Keywords

macular degenerationbrachytherapychoroidal neovascularizationretinal degenerationretinal diseases

Outcome Measures

Primary Outcomes (1)

  • Incidence of serious adverse events 30 to 270 days after treatment

Secondary Outcomes (4)

  • 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

Interventions

Ocular BrachytherapyDEVICE

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Theragenics Clinical Site

Atlanta, Georgia, United States

RECRUITING

Theragenics Clinical Site

Augusta, Georgia, United States

RECRUITING

Theragenics Clinical Site

Indianapolis, Indiana, United States

RECRUITING

Theragenics Clinical Site

Boston, Massachusetts, United States

RECRUITING

Theragenics Clinical Site

Newark, New Jersey, United States

RECRUITING

Theragenics Clinical Site

Raleigh / Durham, North Carolina, United States

RECRUITING

MeSH Terms

Conditions

Macular DegenerationChoroidal NeovascularizationRetinal DegenerationRetinal Diseases

Condition Hierarchy (Ancestors)

Eye DiseasesChoroid DiseasesUveal DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and SymptomsEye Diseases, Hereditary

Central Study Contacts

Theragenics Corporation

CONTACT

1-877-960-1234

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 22, 2004

First Posted

December 23, 2004

Study Start

October 1, 2004

Last Updated

June 24, 2005

Record last verified: 2005-01

Locations

US(6)