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
|Condition or disease||Intervention/treatment||Phase|
|Exudative Retinal Detachment and Uveal Melanoma||Drug: Dexamethasone intravitreal implant||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|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.|
|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|
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.
- 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.
- 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.
- Visual Acuity [ Time Frame: 6 and 12 months after implant insertion ]Measured with ETDRS chart.
- Complications [ Time Frame: Throughout 12 month study period. ]The development of iris neovascularization and neovascular glaucoma.
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
|Contact: Gary A Lamoureux, BSfirstname.lastname@example.org|
|Contact: Anne Marie Lane, MPHemail@example.com|
|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 firstname.lastname@example.org|
|Contact: Anne Marie Lane, MPH 617-573-3735 email@example.com|
|Sub-Investigator: Evangelos S Gragoudas, MD|
|Sub-Investigator: Mary E Aronow, MD|
|Principal Investigator:||Ivana K Kim, MD||Harvard Medical School, Massachusetts Eye and Ear|