Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on November 20, 2014