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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:
Information provided by (Responsible Party):
Peter E. Liggett, New England Retina Associates
ClinicalTrials.gov Identifier:
NCT01253759
First received: March 25, 2009
Last updated: May 1, 2013
Last verified: May 2013
History of Changes
  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:

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Further study details as provided by 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

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Peter E. Liggett, Principal Investigator, New England Retina Associates
ClinicalTrials.gov Identifier: NCT01253759     History of Changes
Other Study ID Numbers: NERA-2
Study First Received: March 25, 2009
Last Updated: May 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on May 16, 2013