Dexamethasone Implant for Retinal Detachment in Uveal Melanoma

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

Sponsors

Lead Sponsor: Ivana K. Kim

Source Massachusetts Eye and Ear Infirmary
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). 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.

Overall Status Recruiting
Start Date April 16, 2018
Completion Date July 2021
Primary Completion Date June 2021
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Incidence of Treatment-Emergent Adverse Events Related to the Implant Throughout 12 month study period
Secondary Outcome
Measure Time Frame
Exudative retinal detachment resolution 6 and 12 months after implant insertion
Visual Acuity 6 and 12 months after implant insertion
Complications Throughout 12 month study period.
Enrollment 20
Condition
Intervention

Intervention Type: Drug

Intervention Name: Dexamethasone intravitreal implant

Description: 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.

Arm Group Label: Treatment Group

Other Name: Ozurdex™

Eligibility

Criteria:

Inclusion Criteria:

- 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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Ivana K Kim, MD Principal Investigator Harvard Medical School, Massachusetts Eye and Ear
Overall Contact

Last Name: Gary A Lamoureux, BS

Phone: 617-573-3067

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator: i. Ocular Melanoma Center, Massachusetts Eye and Ear Gary A Lamoureux, BS 617-573-3067 [email protected] Evangelos S Gragoudas, MD Sub-Investigator Mary E Aronow, MD Sub-Investigator
Location Countries

United States

Verification Date

February 2020

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: Massachusetts Eye and Ear Infirmary

Investigator Full Name: Ivana K. Kim

Investigator Title: Associate Professor of Ophthalmology

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Treatment Group

Type: Experimental

Description: Participants receiving dexamethasone implant.

Label: Non-treatment group (control)

Type: No Intervention

Description: Participants not receiving dexamethasone implant.

Patient Data No
Study Design Info

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 - < 9 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.

Primary Purpose: Treatment

Masking: Single (Participant)

Source: ClinicalTrials.gov