search
Back to results

Dexamethasone Implant for Retinal Detachment in Uveal Melanoma

Primary Purpose

Exudative Retinal Detachment and Uveal Melanoma

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone intravitreal implant
Sponsored by
Ivana K. Kim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exudative Retinal Detachment and Uveal Melanoma focused on measuring Dexamethasone, Uveal Melanoma, Steroid-Implant, Exudative Retinal Detachment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • i. Ocular Melanoma Center, Massachusetts Eye and EarRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment Group

Non-treatment group (control)

Arm Description

Participants receiving dexamethasone implant.

Participants not receiving dexamethasone implant.

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events Related to the Implant
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
Will be assessed using spectral domain optical coherence tomography, B-scan ultrasonography, and optos wide-angle color photography.
Visual Acuity
Measured with ETDRS chart.
Complications
The development of iris neovascularization and neovascular glaucoma.

Full Information

First Posted
August 27, 2019
Last Updated
July 23, 2021
Sponsor
Ivana K. Kim
search

1. Study Identification

Unique Protocol Identification Number
NCT04082962
Brief Title
Dexamethasone Implant for Retinal Detachment in Uveal Melanoma
Official Title
Dexamethasone Intravitreal Implant for the Management of Exudative Retinal Detachment in Patients With Uveal Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 16, 2018 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ivana K. Kim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exudative Retinal Detachment and Uveal Melanoma
Keywords
Dexamethasone, Uveal Melanoma, Steroid-Implant, Exudative Retinal Detachment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Participants receiving dexamethasone implant.
Arm Title
Non-treatment group (control)
Arm Type
No Intervention
Arm Description
Participants not receiving dexamethasone implant.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone intravitreal implant
Other Intervention Name(s)
Ozurdex™
Intervention 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.
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events Related to the Implant
Description
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.
Time Frame
Throughout 12 month study period
Secondary Outcome Measure Information:
Title
Exudative retinal detachment resolution
Description
Will be assessed using spectral domain optical coherence tomography, B-scan ultrasonography, and optos wide-angle color photography.
Time Frame
6 and 12 months after implant insertion
Title
Visual Acuity
Description
Measured with ETDRS chart.
Time Frame
6 and 12 months after implant insertion
Title
Complications
Description
The development of iris neovascularization and neovascular glaucoma.
Time Frame
Throughout 12 month study period.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mustafa Hashmi, BS
Phone
617-573-3066
Email
mustafa_hashmi@meei.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Marie Lane, MPH
Phone
617-573-3735
Email
alane@meei.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivana K Kim, MD
Organizational Affiliation
Harvard Medical School, Massachusetts Eye and Ear
Official's Role
Principal Investigator
Facility Information:
Facility Name
i. Ocular Melanoma Center, Massachusetts Eye and Ear
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mustafa Hashmi, BS
Phone
617-573-3066
Email
mustafa_hashmi@meei.harvard.edu
First Name & Middle Initial & Last Name & Degree
Anne Marie Lane, MPH
Phone
617-573-3735
Email
alane@meei.harvard.edu
First Name & Middle Initial & Last Name & Degree
Evangelos S Gragoudas, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
1255781
Citation
Scotto J, Fraumeni JF Jr, Lee JA. Melanomas of the eye and other noncutaneous sites: epidemiologic aspects. J Natl Cancer Inst. 1976 Mar;56(3):489-91. doi: 10.1093/jnci/56.3.489.
Results Reference
background
PubMed Identifier
17159027
Citation
Collaborative Ocular Melanoma Study Group. The COMS randomized trial of iodine 125 brachytherapy for choroidal melanoma: V. Twelve-year mortality rates and prognostic factors: COMS report No. 28. Arch Ophthalmol. 2006 Dec;124(12):1684-93. doi: 10.1001/archopht.124.12.1684.
Results Reference
background
PubMed Identifier
17065472
Citation
Gragoudas ES. Proton beam irradiation of uveal melanomas: the first 30 years. The Weisenfeld Lecture. Invest Ophthalmol Vis Sci. 2006 Nov;47(11):4666-73. doi: 10.1167/iovs.06-0659. No abstract available.
Results Reference
background
PubMed Identifier
11481276
Citation
Kivela T, Eskelin S, Makitie T, Summanen P. Exudative retinal detachment from malignant uveal melanoma: predictors and prognostic significance. Invest Ophthalmol Vis Sci. 2001 Aug;42(9):2085-93.
Results Reference
background
PubMed Identifier
19788660
Citation
Gibran SK, Kapoor KG. Management of exudative retinal detachment in choroidal melanoma. Clin Exp Ophthalmol. 2009 Sep;37(7):654-9. doi: 10.1111/j.1442-9071.2009.02127.x.
Results Reference
background
PubMed Identifier
12834689
Citation
Char DH, Bove R, Phillips TL. Laser and proton radiation to reduce uveal melanoma-associated exudative retinal detachments. Am J Ophthalmol. 2003 Jul;136(1):180-2.
Results Reference
background
PubMed Identifier
22995029
Citation
Parrozzani R, Pilotto E, Dario A, Miglionico G, Midena E. Intravitreal triamcinolone versus intravitreal bevacizumab in the treatment of exudative retinal detachment secondary to posterior uveal melanoma. Am J Ophthalmol. 2013 Jan;155(1):127-133.e2. doi: 10.1016/j.ajo.2012.06.026. Epub 2012 Sep 18.
Results Reference
background
PubMed Identifier
27630373
Citation
Kim IK, Lane AM, Jain P, Awh C, Gragoudas ES. Ranibizumab for the Prevention of Radiation Complications in Patients Treated With Proton Beam Irradiation for Choroidal Melanoma. Trans Am Ophthalmol Soc. 2016 Aug;114:T2.
Results Reference
background
PubMed Identifier
28218368
Citation
Malcles A, Nguyen AM, Mathis T, Grange JD, Kodjikian L. Intravitreal dexamethasone implant (Ozurdex(R)) for exudative retinal detachment after proton beam therapy for choroidal melanoma. Eur J Ophthalmol. 2017 Aug 30;27(5):596-600. doi: 10.5301/ejo.5000940. Epub 2017 Feb 8.
Results Reference
background
PubMed Identifier
7756680
Citation
Koehler PJ. Use of corticosteroids in neuro-oncology. Anticancer Drugs. 1995 Feb;6(1):19-33. doi: 10.1097/00001813-199502000-00002.
Results Reference
background
PubMed Identifier
18256860
Citation
Sturdza A, Millar BA, Bana N, Laperriere N, Pond G, Wong RK, Bezjak A. The use and toxicity of steroids in the management of patients with brain metastases. Support Care Cancer. 2008 Sep;16(9):1041-8. doi: 10.1007/s00520-007-0395-8. Epub 2008 Feb 7.
Results Reference
background

Learn more about this trial

Dexamethasone Implant for Retinal Detachment in Uveal Melanoma

We'll reach out to this number within 24 hrs