Macular DegenerationPhase 1/2NCT00100087
Safety Study for Treatment of Wet Macular Degeneration Using the TheraSight(TM) Ocular Brachytherapy System
A Phase 1/2 study testing Ocular Brachytherapy in people with Macular Degeneration and Choroidal Neovascularization, run by Theragenics Corporation at 6 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration, Choroidal Neovascularization
- What is being tested?
- Ocular Brachytherapy
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 6 sitesUnited States
- Study dates
- Oct 2004to not given
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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)
Show all 12Show fewer
- 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
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
6 sites in 1 country.
Theragenics Corporation contact
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Theragenics Clinical Site
Atlanta, Georgia
- Recruiting
Theragenics Clinical Site
Augusta, Georgia
- Recruiting
Theragenics Clinical Site
Boston, Massachusetts
- Recruiting
Theragenics Clinical Site
Indianapolis, Indiana
- Recruiting
Theragenics Clinical Site
Newark, New Jersey
- Recruiting
Theragenics Clinical Site
Raleigh / Durham, North Carolina
About this study
Official title: A Safety and Feasibility Study of the TheraSight(TM) Ocular Brachytherapy System for Treatment of Age-Related Macular Degeneration
The study will investigate the safety and feasibility of using the TheraSight(TM) Brachytherapy System for treatment of wet age-related macular degeneration (AMD).
Read the 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.
- Conditions
- Macular Degeneration, Choroidal Neovascularization
- Being tested
- Ocular Brachytherapy
- Keywords
- macular degeneration, brachytherapy, choroidal neovascularization, retinal degeneration, retinal diseases
- Medical subject headings
- Macular Degeneration, Choroidal Neovascularization, Retinal Degeneration, Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ocular BrachytherapyDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2004 (estimated)
- Study startOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Theragenics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00100087
- Sponsor's protocol ID
- NPD-07-01
- Status last verified
- Jan 2005
- First submitted
- 22 Dec 2004
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Feasibility Study of the TheraSight(TM) Ocular Brachytherapy System for Treatment of Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT00100087
- Acronym / sponsor ID
- NPD-07-01
- Conditions
- Macular Degeneration, Choroidal Neovascularization
- Keywords
- macular degeneration, brachytherapy, choroidal neovascularization, retinal degeneration, retinal diseases
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants
- Lead sponsor
- Theragenics CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- First posted
- 23 Dec 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- 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
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ocular Brachytherapy | Device | – |
Primary outcome
Incidence of serious adverse events 30 to 270 days after treatment
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
Related trials for Macular Degeneration
RecruitingPhase 3
A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
Neovascular Age-related Macular Degeneration
RecruitingObservational study
Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration
Age-related Macular Degeneration (AMD)
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingObservational study
Retinal Pigment Epithelium Safety Study For Patients In B4711001
Age Related Macular Degeneration
RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theragenics Corporation contact
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ocular Brachytherapy in people with Macular Degeneration and Choroidal Neovascularization, run by Theragenics Corporation at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Theragenics Corporation (1-877-960-1234), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of serious adverse events 30 to 270 days after treatment. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.