Dexamethasone Implant for Retinal Detachment in Uveal Melanoma

  • STATUS
    Recruiting
  • days left to enroll
    74
  • participants needed
    20
  • sponsor
    Ivana K. Kim
Updated on 24 January 2021

Summary

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). 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.

Details
Condition Exudative Retinal Detachment and Uveal Melanoma
Treatment dexamethasone intravitreal implant
Clinical Study IdentifierNCT04082962
SponsorIvana K. Kim
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Exudative Retinal Detachment and Uveal Melanoma?
Do you have any of these conditions: Do you have Exudative Retinal Detachment and Uveal Melanoma??
Tumor thickness < 9 mm
Associated serous retinal detachment extending beyond tumor, > one quadrant in extent
Primary treatment of ocular melanoma with proton irradiation

Exclusion Criteria

Any pre-existing glaucoma
History of elevated IOP (> 25 mm Hg)
History of steroid response glaucoma
Active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva: active ocular herpes simplex, active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases
Any history of ocular herpes simplex
Torn or ruptured posterior lens capsule
Known hypersensitivity to any components of the dexamethasone intravitreal implant
Women of child-bearing potential: pregnant or planning to become pregnant
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