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

Information source: Charite University, Berlin, Germany
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Exudative Retinal Detachment; Uveal Melanoma

Intervention: Triamcinolone Acetonide (Drug); Transpupillary thermotherapy (Procedure)

Phase: Phase 4

Status: Recruiting

Sponsored by: Charite University, Berlin, Germany

Official(s) and/or principal investigator(s):
Ira Seibel, MD, Principal Investigator, Affiliation: Charite University, Berlin, Germany

Overall contact:
Ira Seibel, MD, Email: ira.seibel@charite.de

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.

Clinical Details

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 design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Ira Seibel, MD, Email: ira.seibel@charite.de

Charité Universitätsmedizin Berlin, Berlin 12200, Germany; Recruiting
Ira Seibel, MD, Email: ira.seibel@charite.de
Additional Information

Related publications:

Desjardins L, Lumbroso-Le Rouic L, Levy-Gabriel C, Dendale R, Delacroix S, Nauraye C, Estève M, Plancher C, Asselain B. Combined proton beam radiotherapy and transpupillary thermotherapy for large uveal melanomas: a randomized study of 151 patients. Ophthalmic Res. 2006;38(5):255-60. Epub 2006 Jul 28.

Parrozzani R, Pilotto E, Dario A, Miglionico G, Midena E. Intravitreal triamcinolone versus intravitreal bevacizumab in the treatment of exudative retinal detachment secondary to posterior uveal melanoma. Am J Ophthalmol. 2013 Jan;155(1):127-133.e2. doi: 10.1016/j.ajo.2012.06.026. Epub 2012 Sep 18.

Seibel I, Cordini D, Willerding G, Riechardt AI, Joussen AM. Endodrainage, Tumor Photocoagulation, and Silicone Oil Tamponade for Primary Exudative Retinal Detachment due to Choroidal Melanoma Persisting after Proton Beam Therapy. Ocular Oncology and Pathology.2014 doi:10.1159/000365333

Starting date: January 2015
Last updated: March 4, 2015

Page last updated: August 23, 2015

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