TTT Versus TTT and Triamcinolone to Decrease Exudation in Choroidal Melanoma After Proton Beam Therapy
This trial is active, not recruiting.
|Conditions||exudative retinal detachment, uveal melanoma|
|Treatments||triamcinolone acetonide, transpupillary thermotherapy|
|Sponsor||Charite University, Berlin, Germany|
|Start date||January 2015|
|End date||December 2017|
|Trial size||50 participants|
|Trial identifier||NCT02379000, 2404|
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.
|Intervention model||parallel assignment|
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
Toxic tumor syndrone and required secondary vitrectomy
time frame: 3 years
All participants at least 18 years old.
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
|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|
|Principal investigator||Ira Seibel, MD|
|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.|
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