NCT01253759

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2009

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

December 3, 2010

Completed
Last Updated

May 3, 2013

Status Verified

May 1, 2013

Enrollment Period

Same day

First QC Date

March 25, 2009

Last Update Submit

May 1, 2013

Conditions

Choroidal Melanoma

Keywords

Transpupillary thermotherapyChoroidal melanomaICG-Photodynamic therapy

Study Arms (1)

1

Combined treatment of Transpupillary Thermotherapy and ICG-based photodynamic therapy (PDT)

Procedure: TTT + ICG-based PDT

Interventions

TTT + ICG-based PDTPROCEDURE
1

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects selected from retina specialist general patient population.

You may qualify if:

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

You may not qualify if:

  • Patients with ocular inflammation.
  • Patients with another active ocular disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New England Retina Associates

Hamden, Connecticut, 06518, United States

Location

MeSH Terms

Conditions

Uveal Melanoma

Condition Hierarchy (Ancestors)

MelanomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasUveal NeoplasmsEye NeoplasmsNeoplasms by SiteEye DiseasesUveal Diseases

Study Officials

  • Peter E Liggett, MD

    New England Retina Associates

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 25, 2009

First Posted

December 3, 2010

Study Start

January 1, 2009

Primary Completion

January 1, 2009

Study Completion

March 1, 2009

Last Updated

May 3, 2013

Record last verified: 2013-05

Locations

US(1)