Dexamethasone Implant for Retinal Detachment in Uveal Melanoma

Sponsor

Ivana K. Kim (Other)

Overall Status

Recruiting

CT.gov ID

NCT04082962

Collaborator

(none)

Enrollment

Location

Arms

50.5

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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) 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.

Condition or Disease	Intervention/Treatment	Phase
Exudative Retinal Detachment and Uveal Melanoma	Drug: Dexamethasone intravitreal implant	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 16, 2018

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Group Participants receiving dexamethasone implant.	Drug: Dexamethasone intravitreal 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. Other Names: Ozurdex™
No Intervention: Non-treatment group (control) Participants not receiving dexamethasone implant.

Arm

Intervention/Treatment

Experimental: Treatment Group

Participants receiving dexamethasone implant.

Drug: Dexamethasone intravitreal 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.

Other Names:

Ozurdex™

No Intervention: Non-treatment group (control)

Participants not receiving dexamethasone implant.

Outcome Measures

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events Related to the Implant [Throughout 12 month study period]
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.

Secondary Outcome Measures

Exudative retinal detachment resolution [6 and 12 months after implant insertion]
Will be assessed using spectral domain optical coherence tomography, B-scan ultrasonography, and optos wide-angle color photography.
Visual Acuity [6 and 12 months after implant insertion]
Measured with ETDRS chart.
Complications [Throughout 12 month study period.]
The development of iris neovascularization and neovascular glaucoma.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Tumor thickness <= 10 mm.
Associated serous retinal detachment extending beyond tumor, > two clockhours in extent.
Primary treatment of ocular melanoma with proton irradiation or plaque radiotherapy.

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.