TTT Versus TTT and Triamcinolone to Decrease Exudation in Choroidal Melanoma After Proton Beam Therapy
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| ClinicalTrials.gov Identifier: NCT02379000 |
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Recruitment Status : Unknown
Verified February 2017 by Dr. Ira Seibel, Charite University, Berlin, Germany.
Recruitment status was: Active, not recruiting
First Posted : March 4, 2015
Last Update Posted : February 8, 2017
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Sponsor:
Charite University, Berlin, Germany
Information provided by (Responsible Party):
Dr. Ira Seibel, Charite University, Berlin, Germany
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Exudative Retinal Detachment Uveal Melanoma | Drug: Triamcinolone Acetonide Procedure: Transpupillary thermotherapy | Phase 4 |
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 (Clinical Trial) |
| Estimated Enrollment : | 50 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| 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 |
| Study Start Date : | January 2015 |
| Estimated Primary Completion Date : | December 2017 |
| Estimated Study Completion Date : | July 2018 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Melanoma
Drug Information available for:
Triamcinolone diacetate
Triamcinolone acetonide
Triamcinolone
Triamcinolone hexacetonide
| Arm | Intervention/treatment |
|---|---|
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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
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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 |
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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.
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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 |
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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
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 |
| Other Study ID Numbers: |
2404 |
| First Posted: | March 4, 2015 Key Record Dates |
| Last Update Posted: | February 8, 2017 |
| Last Verified: | February 2017 |
Additional relevant MeSH terms:
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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 Eye Diseases Triamcinolone |
Triamcinolone Acetonide Triamcinolone hexacetonide 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 |