Choroidal MelanomaNCT01253759
Long Term Results of Combined Transpupillary Thermotherapy (TTT) Indocyanine Green (ICG) Based Photodynamic Therapy (PDT) in Choroidal Melanoma
An observational study of Choroidal Melanoma, run by New England Retina Associates at 1 site in United States.
Trial summary
This is a report of 10 years results of combined Transpupillary thermotherapy (TTT) treatment with Indocyanine green (ICG) in controlling small and medium-sized choroidal melanomas. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Choroidal Melanoma
- What is being tested?
- TTT + ICG-based PDT
- Type of treatment
- Surgery or procedure
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Mar 2009
- Phase
- Observational
- 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 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects selected from retina specialist general patient population.
Who may be able to join
- Small and medium-sized choroidal melanoma
- Patients older than 18 years old.
- Patients who can read and signed the informed consent.
Who cannot join
- Patients with ocular inflammation.
- Patients with another active ocular disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
New England Retina Associates
Hamden, Connecticut, 06518
About this study
Official title: 10 Years Report of Combined Simultaneous Transpupillary Thermotherapy and ICG-based Photodynamic Therapy for Choroidal Melanoma
This is a report of 10 years results of combined Transpupillary thermotherapy (TTT) treatment with Indocyanine green (ICG) in controlling small and medium-sized choroidal melanomas.
Read the detailed description
The study was done in a Clinical practice setting. Forty six eyes of 46 patients with small or medium-sized choroidal melanomas were treated with i-TTT using infrared light delivered from a diode laser. All patients were evaluated to rule out systemic metastasis and underwent a complete ophthalmological evaluation including: Slit lamp biomicroscopy, dilated fundus examination, Fluorescein angiography, Optical coherence tomography and A/B ultrasonography. Main outcome measures were: Changes in visual acuity, complications associated with the treatment and local control of the tumor.
- Conditions
- Choroidal Melanoma
- Being tested
- TTT + ICG-based PDT
- Keywords
- Transpupillary thermotherapy, Choroidal melanoma, ICG-Photodynamic therapy
- Medical subject headings
- Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTT + ICG-based PDTProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Combined treatment of Transpupillary Thermotherapy and ICG-based photodynamic therapy (PDT) Receives: Procedure: TTT + ICG-based PDT |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startJan 2009
- Primary completionJan 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Choroidal MelanomaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- New England Retina Associates
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter E. Liggett, New England Retina Associates
- Investigators
- Peter E Liggett, MD, Study director, New England Retina Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01253759
- Sponsor's protocol ID
- NERA-2
- Status last verified
- May 2013
- First submitted
- 25 Mar 2009
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 10 Years Report of Combined Simultaneous Transpupillary Thermotherapy and ICG-based Photodynamic Therapy for Choroidal Melanoma
- ClinicalTrials.gov ID
- NCT01253759
- Acronym / sponsor ID
- NERA-2
- Conditions
- Choroidal Melanoma
- Keywords
- Transpupillary thermotherapy, Choroidal melanoma, ICG-Photodynamic therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- New England Retina AssociatesUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 3 Dec 2010 (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.
This is a report of 10 years results of combined Transpupillary thermotherapy (TTT) treatment with Indocyanine green (ICG) in controlling small and medium-sized choroidal melanomas.
Detailed description
The study was done in a Clinical practice setting. Forty six eyes of 46 patients with small or medium-sized choroidal melanomas were treated with i-TTT using infrared light delivered from a diode laser. All patients were evaluated to rule out systemic metastasis and underwent a complete ophthalmological evaluation including: Slit lamp biomicroscopy, dilated fundus examination, Fluorescein angiography, Optical coherence tomography and A/B ultrasonography. Main outcome measures were: Changes in visual acuity, complications associated with the treatment and local control of the tumor.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: TTT + ICG-based PDTCombined treatment of Transpupillary Thermotherapy and ICG-based photodynamic therapy (PDT) |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects selected from retina specialist general patient population.
Key inclusion criteria (3 listed)
- Small and medium-sized choroidal melanoma
- Patients older than 18 years old.
- Patients who can read and signed the informed consent.
Key exclusion criteria (2 listed)
- Patients with ocular inflammation.
- Patients with another active ocular disease.
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 |
|---|---|---|
| TTT + ICG-based PDT | Procedure or surgery | 1 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2013.
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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.
Peter E Liggett, MD study director
New England Retina Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Choroidal Melanoma, run by New England Retina Associates at 1 site 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 3 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 3 May 2013.