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Dexamethasone Implant for Retinal Detachment in Uveal Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04082962
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
Ivana K. Kim, 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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 - < 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.
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 : April 16, 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : July 2021


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 Name: Ozurdex™

No Intervention: Non-treatment group (control)
Participants not receiving dexamethasone implant.



Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events Related to the Implant [ Time Frame: 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 :
  1. Exudative retinal detachment resolution [ Time Frame: 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.

  2. Visual Acuity [ Time Frame: 6 and 12 months after implant insertion ]
    Measured with ETDRS chart.

  3. Complications [ Time Frame: Throughout 12 month study period. ]
    The development of iris neovascularization and neovascular glaucoma.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04082962


Contacts
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Contact: Gary A Lamoureux, BS 617-573-3067 gary_lamoureux@meei.harvard.edu
Contact: Anne Marie Lane, MPH 617-573-3735 alane@meei.harvard.edu

Locations
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United States, Massachusetts
i. Ocular Melanoma Center, Massachusetts Eye and Ear Recruiting
Boston, Massachusetts, United States, 02114
Contact: Gary A Lamoureux, BS    617-573-3067    gary_lamoureux@meei.harvard.edu   
Contact: Anne Marie Lane, MPH    617-573-3735    alane@meei.harvard.edu   
Sub-Investigator: Evangelos S Gragoudas, MD         
Sub-Investigator: Mary E Aronow, MD         
Sponsors and Collaborators
Ivana K. Kim
Investigators
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Principal Investigator: Ivana K Kim, MD Harvard Medical School, Massachusetts Eye and Ear
Publications:

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Responsible Party: Ivana K. Kim, Associate Professor of Ophthalmology, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT04082962    
Other Study ID Numbers: 2019P000127
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ivana K. Kim, Massachusetts Eye and Ear Infirmary:
Dexamethasone
Uveal Melanoma
Steroid-Implant
Exudative Retinal Detachment
Additional relevant MeSH terms:
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Melanoma
Uveal Neoplasms
Retinal Detachment
Dissociative Disorders
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Mental Disorders
Retinal Diseases
Eye Diseases
Eye Neoplasms
Neoplasms by Site
Uveal Diseases
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents