Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Eye Diseases

Behaviors and Mental Disorders

Rare Diseases

Melanoma

Retinal Detachment

Uveal Neoplasms

Conversion Disorder

Dissociative Disorders

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

Mental Disorders

Psychotic Disorders

Eye Neoplasms

Uveal Diseases

Retinal Diseases

Intraocular Melanoma

Neuroendocrine Tumor

Neuroepithelioma

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Dermatologic Agents

Dexamethasone

Dexamethasone acetate

BB 1101

Glycolic acid

Glucocorticoids

Hormones

Hormone Antagonists

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	Link
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 and uveal melanoma