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

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 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

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