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Long Term Results of Combined Transpupillary Thermotherapy (TTT) Indocyanine Green (ICG) Based Photodynamic Therapy (PDT) in Choroidal Melanoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01253759
First Posted: December 3, 2010
Last Update Posted: May 3, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Peter E. Liggett, New England Retina Associates
  Purpose
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.

Condition Intervention Phase
Choroidal Melanoma Procedure: TTT + ICG-based PDT Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: 10 Years Report of Combined Simultaneous Transpupillary Thermotherapy and ICG-based Photodynamic Therapy for Choroidal Melanoma

Resource links provided by NLM:


Further study details as provided by Peter E. Liggett, New England Retina Associates:

Enrollment: 46
Study Start Date: January 2009
Study Completion Date: March 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Combined treatment of Transpupillary Thermotherapy and ICG-based photodynamic therapy (PDT)
Procedure: TTT + ICG-based PDT

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects selected from retina specialist general patient population.
Criteria

Inclusion Criteria:

  • Small and medium-sized choroidal melanoma
  • Patients older than 18 years old.
  • Patients who can read and signed the informed consent.

Exclusion Criteria:

  • Patients with ocular inflammation.
  • Patients with another active ocular disease.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01253759


Locations
United States, Connecticut
New England Retina Associates
Hamden, Connecticut, United States, 06518
Sponsors and Collaborators
New England Retina Associates
Investigators
Study Director: Peter E Liggett, MD New England Retina Associates
  More Information

Responsible Party: Peter E. Liggett, Principal Investigator, New England Retina Associates
ClinicalTrials.gov Identifier: NCT01253759     History of Changes
Other Study ID Numbers: NERA-2
First Submitted: March 25, 2009
First Posted: December 3, 2010
Last Update Posted: May 3, 2013
Last Verified: May 2013

Keywords provided by Peter E. Liggett, New England Retina Associates:
Transpupillary thermotherapy
Choroidal melanoma
ICG-Photodynamic therapy

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas