Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Eye Diseases

Rare Diseases

Melanoma

Retinal Detachment

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Retinal Diseases

Intraocular Melanoma

Neuroendocrine Tumor

Neuroepithelioma

Anti-Inflammatory Agents

All Drugs and Chemicals

Triamcinolone

Triamcinolone Acetonide

Triamcinolone hexacetonide

Triamcinolone diacetate

Glucocorticoids

Hormones

Hormone Antagonists

Immunosuppressive Agents

Immunologic Factors

Enzyme Inhibitors

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

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.

Under sterile conditions an intravitreal injection of trimcinolone acetonide 4 mg was performed.

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.

Transpupillary thermotherapy

Ira Seibel, MD

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.

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.

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

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

If tumor relaxed lipid exudates or a neovascular glaucoma develop a secondary vitrectomy will be required to preserve the globe.

Charite University, Berlin, Germany

Behaviors and Mental Disorders

Uveal Neoplasms

Conversion Disorder

Dissociative Disorders

Mental Disorders

Psychotic Disorders

Eye Neoplasms

Uveal Diseases

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

Dermatologic Agents

Dexamethasone

Dexamethasone acetate

BB 1101

Glycolic acid

Antineoplastic Agents, Hormonal

Participants receiving dexamethasone implant.

Participants not receiving dexamethasone implant.

Ozurdex™ is an intravitreal implant containing dexamethasone 0.7 mg in the NOVADUR® solid polymer drug delivery system (NOVADUR™ system contains poly (D,L-lactide-co-glycolide) PLGA intravitreal polymer matrix, which slowly degrades to lactic acid and glycolic acid.). Ozurdex™ is preservative-free. It is supplied in a foil pouch with a single-use plastic applicator.

Dexamethasone intravitreal implant

Mustafa Hashmi, BS

Anne Marie Lane, MPH

Evangelos S Gragoudas, MD

Ivana K Kim, MD

This is an investigator-initiated Phase I study of a single dose of an intravitreally-administered dexamethasone implant (Ozurdex™) in subjects with uveal melanomas (UM) and exudative retinal detachments (ERD: build-up of fluid under the retina that causes it to detach) being treated with proton beam radiation (PBI) or plaque radiotherapy. Although PBI is an effective treatment for UM, ERDs may persist after radiation, leading to vision loss. Effective treatments for ERD are currently lacking. We are conducting this study to evaluate whether Ozurdex™ can help resolve ERDs that occur in patients with UM. Ozurdex™ has been approved by the Food and Drug Administration (FDA) to treat certain ocular conditions such as macular edema, non-infectious uveitis, and diabetic macular edema but it is not approved for use in patients with UM and ERD. This study will determine the safety of the dexamethasone implant and provide preliminary evidence of efficacy in this population.

Twenty patients will be enrolled in this randomized pilot study. Patients will be randomized (1:1) to receive the dexamethasone implant or no treatment. A stratified randomization scheme will be performed, with strata defined by tumor height (\< 5mm and 5mm - \< 10 mm). Patients with newly diagnosed choroidal melanoma meeting specified eligibility criteria will be randomly assigned to receive Ozurdex™ (0.7 mg dexamethasone) or no treatment at the time of their tumor localization (tantalum ring placement) surgery for patients receiving PBI or at the time of plaque removal for those patients receiving plaque radiotherapy.

Dexamethasone Implant for Retinal Detachment in Uveal Melanoma

Dexamethasone Intravitreal Implant for the Management of Exudative Retinal Detachment in Patients With Uveal Melanoma

The primary outcome of the study will be to evaluate the safety of the implant. All adverse effects not related to the melanoma or radiation treatment identified by ocular examination, diagnostic tests, and subject reporting will be tabulated. This includes significant vision loss, other sight-threatening events, and unforeseen systemic events.

Will be assessed using spectral domain optical coherence tomography, B-scan ultrasonography, and optos wide-angle color photography.

The development of iris neovascularization and neovascular glaucoma.

Ivana K. Kim

Associate Professor of Ophthalmology

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
TTT Versus TTT and Triamcinolone to Decrease Exudation in Choroidal Melanoma After Proton Beam Therapy	NCT02379000	Exudative Retin... Uveal Melanoma	Triamcinolone A... Transpupillary ...	18 Years -	Charite University, Berlin, Germany
Dexamethasone Implant for Retinal Detachment in Uveal Melanoma	NCT04082962	Exudative Retin...	Dexamethasone i...	18 Years -	Massachusetts Eye and Ear Infirmary
Dexamethasone Implant for Retinal Detachment in Uveal Melanoma	NCT04082962	Exudative Retin...	Dexamethasone i...	18 Years -	Massachusetts Eye and Ear Infirmary

Spots Global Cancer Trial Database for exudative retinal detachment