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Brachytherapy

Ocular Brachytherapy for Wet Macular Degeneration

Phase 1 & 2

Waitlist Available

Research Sponsored by Theragenics Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subretinal fibrosis must comprise less than 25% of the total lesion

Active primary or recurrent subfoveal CNV secondary to AMD with minimally classic or occult lesion meeting specific criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial will study whether a newbrachytherapy system is safe and effective at treating wet age-related macular degeneration.

Who is the study for?

This trial is for people over 50 with wet age-related macular degeneration (AMD) and specific characteristics of their condition, like recent changes in lesion size or hemorrhage. They must have vision loss and not be part of other AMD treatment trials. Exclusions include those with certain past surgeries, diabetes requiring medication, major heart events within a year, allergies to fluorescein dye, or pregnancy.Check my eligibility

What is being tested?

The TheraSight(TM) Brachytherapy System's safety and effectiveness are being tested as a treatment for wet AMD. This involves using targeted radiation therapy to treat abnormal blood vessels in the eye that cause vision loss from AMD.See study design

What are the potential side effects?

While the side effects aren't specified here, brachytherapy can generally lead to inflammation, discomfort or pain at the site of treatment, potential damage to surrounding tissues including possible impact on vision, and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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Less than 25% of my eye lesion is made up of scar tissue.

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I have a specific type of wet AMD affecting the center of my vision.

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My cancer lesion is smaller than 6 mm.

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I am 50 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of serious adverse events 30 to 270 days after treatment

Secondary outcome measures

Feasibility of device use based on physician interviews and ultrasonography

Observation of retinal and angiographic appearance of CNV lesion and best-corrected visual acuity

Reported adverse events occurring at any time after treatment

+1 more

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Theragenics CorporationLead Sponsor

1 Previous Clinical Trials

660 Total Patients Enrolled

Media Library

TheraSight(TM) Ocular Brachytherapy System (Brachytherapy) Clinical Trial Eligibility Overview. Trial Name: NCT00100087 — Phase 1 & 2

Choroidal Neovascularization Research Study Groups:

Choroidal Neovascularization Clinical Trial 2023: TheraSight(TM) Ocular Brachytherapy System Highlights & Side Effects. Trial Name: NCT00100087 — Phase 1 & 2

TheraSight(TM) Ocular Brachytherapy System (Brachytherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00100087 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who qualifies to take part in this clinical research?

"This clinical trial is currently enrolling 30 individuals with choroidal neovascularization, aged between 50 and 80. To qualify for the study, participants must possess a better best-corrected vision in their fellow eye than in their study eye as measured by an ETDRS chart; additionally, they must have suffered at least one Snellen line of visual acuity loss within 180 days preceding screening. Furthermore, submacular blood may not comprise more than 75% of the total lesion area nor may subretinal fibrosis exceed 25%."

Answered by AI

Are there any specific healthcare centers that are currently undertaking this research endeavor?

"At present, 6 sites are enrolling subjects for this medical trial. These include Atlanta, Newark and Raleigh / Durham along with 3 other nearby locations. It is encouraged to select the closest location so as to reduce any necessary travel obligations incurred by participation."

Answered by AI

Does this experiment provide an opportunity for adults older than 35 to participate?

"This research project is seeking participants aged 50 and above, up to 0 years."

Answered by AI

Are there openings currently available to join this experiment?

"Information found on clinicaltrials.gov suggests that this medical review is no longer seeking participant involvement. Initially posted in October 2004, the trial's last update was recorded back in June 2005. Despite its inactive status, there are still 169 other studies actively recruiting patients at present time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2004. "Safety Study for Treatment of Wet Macular Degeneration Using the TheraSight(TM) Ocular Brachytherapy System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00100087.

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