TTT Versus TTT and Triamcinolone to Decrease Exudation in Choroidal Melanoma After Proton Beam Therapy

February 6, 2017 updated by: Dr. Ira Seibel, Charite University, Berlin, Germany

Transpupillary Thermotherapy (TTT) Alone Versus the Combined Therapy Consisting of TTT and Intravitreal Injection of Triamcinolone to Decrease Exudation in Choroidal Melanoma After Proton Beam Therapy

Proton beam therapy is a safe irradiation modality for choroidal melanoma. But often after irradiation the exudation increases resulting in an exudative retinal detachment requiring vitreoretinal surgery. It is known that intravitreally injected triamcinolone and TTT is capable to decrease the exudation. If there is any advantage in a combined treatment this study will investigate.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Proton beam therapy is an eye preserving irradiation modality for uveal melanoma. After proton beam therapy tumor related lipid exudation and exudative retinal detachment often increase. Therefore vitreoretinal surgery is sometimes required to reattach the retina to protect visual acuity. It is known that intravitreally injected triamcinolone and TTT is capable to decrease exudation. If there is any advantage in a combined treatment and if it is that effective to possibly avoid vitreoretinal surgery this study will investigate.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 12200
        • Charité Universitätsmedizin Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

•exudation (tumor associated exudation/exudative retinal detachment) after proton beam therapy in choroidal melanoma and/or ciliary body melanoma

Exclusion criteria:

  • Tumor recurrence
  • Endoresection and / or previous vitrectomy
  • Treatment with anti-angiogenic drugs or intravitreal corticosteroids or any other investigational drug within 3 months prior to randomisation
  • Prior laser photocoagulation treatment within 3 months (focal / grid laser) or 6 months (panretinal) prior to study entry
  • Known hypersensitivity against local anaesthetics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Transpupillary therapy alone
Transpupillary thermotherapy is performed as monotherapy. It is performed with an infrared diode laser adapted to a slit-lamp biomicroscope at a wavelength of 810 nm and beam diameters of 0.5, 0.8, 1.2, 2.0, or 3.0 mm using a contact lens and through a dilated pupil. Each TTT spot was applied for a duration of about 1 minute to achieve a grayish-white color on the surface of the tumor. TTT could be repeated at intervals of 6-8 weeks with the goal of achieving a complete resolution of fluid
Procedure: Transpupillary thermotherapy
We delivered TTT with an infrared diode laser adapted to a slit-lamp biomicroscope at a wavelength of 810 nm and beam diameters of 0.5, 0.8, 1.2, 2.0, or 3.0 mm using a contact lens and through a dilated pupil. Each TTT spot was applied for a duration of about 1 minute to achieve a grayish-white color on the surface of the tumor.
Other Names:
  • TTT
ACTIVE_COMPARATOR: TTT+Triamcinolone Acetonide
transpupillary thermotherapy followed by an intravitreal injection of triamcinolone. It is performed with an infrared diode laser adapted to a slit-lamp biomicroscope at a wavelength of 810 nm and beam diameters of 0.5, 0.8, 1.2, 2.0, or 3.0 mm using a contact lens and through a dilated pupil. Each TTT spot was applied for a duration of about 1 minute to achieve a grayish-white color on the surface of the tumor. After an intravitreal injection of triamcinolone was perfomed under sterile conditions. TTT and triamcinolone injection could be repeated at intervals of 6-8 weeks with the goal of achieving a complete resolution of fluid.
Procedure: Transpupillary thermotherapy
We delivered TTT with an infrared diode laser adapted to a slit-lamp biomicroscope at a wavelength of 810 nm and beam diameters of 0.5, 0.8, 1.2, 2.0, or 3.0 mm using a contact lens and through a dilated pupil. Each TTT spot was applied for a duration of about 1 minute to achieve a grayish-white color on the surface of the tumor.
Other Names:
  • TTT
Drug: Triamcinolone Acetonide
Under sterile conditions an intravitreal injection of trimcinolone acetonide 4 mg was performed.
Other Names:
  • Volon A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Decrease of exudation, as indicated by compairing the extent of exudation measured in quadrants in color fundus photographs, autofluorescence imaging, and/or optical coherence tomogaphy.
Time Frame: 6 weeks, 6 months
6 weeks, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toxic tumor syndrone and required secondary vitrectomy
Time Frame: 3 years
If tumor relaxed lipid exudates or a neovascular glaucoma develop a secondary vitrectomy will be required to preserve the globe.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Ira Seibel, MD, Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

July 1, 2018

Study Registration Dates

First Submitted

February 23, 2015

First Submitted That Met QC Criteria

February 26, 2015

First Posted (ESTIMATE)

March 4, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

February 8, 2017

Last Update Submitted That Met QC Criteria

February 6, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2404

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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