Brief Title
TTT Versus TTT and Triamcinolone to Decrease Exudation in Choroidal Melanoma After Proton Beam Therapy
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
Brief Summary
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.
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 Phase
Phase 4
Study Type
Interventional
Primary Outcome
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.
Secondary Outcome
Toxic tumor syndrone and required secondary vitrectomy
Condition
Exudative Retinal Detachment
Intervention
Triamcinolone Acetonide
Study Arms / Comparison Groups
Transpupillary therapy alone
Description: 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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
50
Start Date
January 2015
Completion Date
July 2018
Primary Completion Date
December 2017
Eligibility 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ira Seibel, MD, ,
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT02379000
Organization ID
2404
Responsible Party
Principal Investigator
Study Sponsor
Charite University, Berlin, Germany
Study Sponsor
Ira Seibel, MD, Principal Investigator, Charite University, Berlin, Germany
Verification Date
February 2017