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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2005 by Theragenics Corporation.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Theragenics Corporation
ClinicalTrials.gov Identifier:
NCT00100087
First received: December 22, 2004
Last updated: June 23, 2005
Last verified: January 2005
  Purpose

The study will investigate the safety and feasibility of using the TheraSight(TM) Brachytherapy System for treatment of wet age-related macular degeneration (AMD).


Condition Intervention Phase
Macular Degeneration
Choroidal Neovascularization
Device: Ocular Brachytherapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Safety and Feasibility Study of the TheraSight(TM) Ocular Brachytherapy System for Treatment of Age-Related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by Theragenics Corporation:

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

Estimated Enrollment: 30
Study Start Date: October 2004
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00100087

Contacts
Contact: Theragenics Corporation 1-877-960-1234

Locations
United States, Georgia
Theragenics Clinical Site Recruiting
Atlanta, Georgia, United States
Theragenics Clinical Site Recruiting
Augusta, Georgia, United States
United States, Indiana
Theragenics Clinical Site Recruiting
Indianapolis, Indiana, United States
United States, Massachusetts
Theragenics Clinical Site Recruiting
Boston, Massachusetts, United States
United States, New Jersey
Theragenics Clinical Site Recruiting
Newark, New Jersey, United States
United States, North Carolina
Theragenics Clinical Site Recruiting
Raleigh / Durham, North Carolina, United States
Sponsors and Collaborators
Theragenics Corporation
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00100087     History of Changes
Other Study ID Numbers: NPD-07-01
Study First Received: December 22, 2004
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Theragenics Corporation:
macular degeneration
brachytherapy
choroidal neovascularization
retinal degeneration
retinal diseases

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on August 27, 2014