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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dr. Ira Seibel, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT02379000
First received: February 23, 2015
Last updated: February 6, 2017
Last verified: February 2017
  Purpose
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.

Condition Intervention Phase
Exudative Retinal Detachment
Uveal Melanoma
Drug: Triamcinolone Acetonide
Procedure: Transpupillary thermotherapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Dr. Ira Seibel, Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 50
Study Start Date: January 2015
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.
Drug: Triamcinolone Acetonide
Under sterile conditions an intravitreal injection of trimcinolone acetonide 4 mg was performed.
Other Name: Volon A
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 Name: TTT

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT02379000

Locations
Germany
Charité Universitätsmedizin Berlin
Berlin, Germany, 12200
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Ira Seibel, MD Charite University, Berlin, Germany
  More Information

Publications:
Responsible Party: Dr. Ira Seibel, TTT Versus TTT and Triamcinolone to Decrease Exudation in Choroidal Melanoma After Proton Beam Therapy, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02379000     History of Changes
Other Study ID Numbers: 2404
Study First Received: February 23, 2015
Last Updated: February 6, 2017

Additional relevant MeSH terms:
Eye Diseases
Melanoma
Retinal Detachment
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Retinal Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 25, 2017