Dexamethasone Intravitreal Implant for Treatment of Macular Edema After Plaque Radiotherapy of Uveal Melanoma

Learn more about:
Related Clinical Trial
A Study of Concurrent Stereotactic Body Radiotherapy With Ipi and Nivo in Metastatic Uveal Melanoma Single Arm Trial of Tumor-Treating Fields in Combination With Nivolumab and Ipilimumab in Metastatic Uveal Melanoma Managed Access Program Supporting Patient Access to Tebentafusp Efficacy of Spartalizumab Across Multiple Cancer-types in Patients With PD1-high mRNA Expressing Tumors Frequency and Clinical Phenotype of BAP1 Hereditary Predisposition Syndrome A Study of APG-115 in Combination With Pembrolizumab in Patients With Metastatic Melanomas or Advanced Solid Tumors Early Integration of Supportive Care Into Standard Oncology Care for Metastatic Uveal Melanoma Patients Defactinib (VS-6063) Combined With VS-6766 in Patients With Metastatic Uveal Melanoma Study of PAC-1 and Entrectinib for Patients With Metastatic Uveal Melanoma A Prospective Natural History Study in Uveal Melanoma Uveal Melanoma and Brachytheraphy: Long-term Outcomes. A Study of RO7293583 in Participants With Unresectable Metastatic Tyrosinase Related Protein 1 (TYRP1)-Positive Melanomas Study to Evaluate the Safety of IMM-01 in Patients With Advanced Solid Tumours Isolated Hepatic Perfusion in Combination With Ipilimumab and Nivolumab in Patients With Uveal Melanoma Metastases Study of Safety and Tolerability of BCA101 Alone and in Combination With Pembrolizumab in Patients With EGFR-driven Advanced Solid Tumors Follow-up of Patients With Uveal Melanoma Adapted to the Risk of Relapse (SALOME) Phase 2 Trial of AU-011 Via Suprachoroidal Administration With a Dose Escalation and Randomized, Masked Dose Expansion Designed to Evaluate Safety and Efficacy of AU-011 in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma Vorinostat in Treating Patients With Metastatic or Unresectable Melanoma A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies Cabozantinib-S-Malate Compared With Temozolomide or Dacarbazine in Treating Patients With Metastatic Melanoma of the Eye That Cannot Be Removed by Surgery Epacadostat and Vaccine Therapy in Treating Patients With Stage III-IV Melanoma Sargramostim, Vaccine Therapy, or Sargramostim and Vaccine Therapy in Preventing Disease Recurrence in Patients With Melanoma That Has Been Removed By Surgery A Study of PLX2853 in Advanced Malignancies. Combined PET/CT Imaging for the Early Detection of Ocular Melanoma Metastasis Compared to CT Scanning Alone A Trial of Niraparib in BAP1 and Other DNA Damage Response (DDR) Deficient Neoplasms (UF-STO-ETI-001) TTT Versus TTT and Triamcinolone to Decrease Exudation in Choroidal Melanoma After Proton Beam Therapy C7R-GD2.CART Cells for Patients With Relapsed or Refractory Neuroblastoma and Other GD2 Positive Cancers (GAIL-N) Genetic Predictors of Efficiency and Safety of ICIs in Patients With Different Malignancies (ICIPRESIST-0519) Treatment Of Radiation Retinopathy Trial Temozolomide or Selumetinib in Treating Patients With Metastatic Melanoma of the Eye Intravitreal Ranibizumab for the Prevention of Radiation Maculopathy Following Plaque Radiotherapy Ph 1 Study in Subjects With Tumors Requiring Arginine to Assess ADI-PEG 20 With Pemetrexed and Cisplatin Study in Subjects With Small Primary Choroidal Melanoma Study Multicentre Evaluating the Effectiveness and Toxicity Sorafenib (Nexavar®) in Adult Patients With Uveal Melanoma and Metastatic Dissemination Trial of AEB071 in Combination With BYL719 in Patients With Melanoma Halt Growth of Liver Tumors From Uveal Melanoma With Closure of Liver Artery Following Injection of GM-CSF Vorinostat in Treating Patients With Metastatic Melanoma of the Eye Radiation Therapy in Preventing Liver Metastases in Patients With Uveal Melanoma Who HaveMonosomy 3 or DecisionDx Class 2 Disease and Are More Likely to Develop Liver Metastases 5 Year Registry Study to Track Clinical Application of DecisionDx-UM Assay Results and Associated Patient Outcomes Hypofractionated Stereotactic Linear Accelerator Radiotherapy of Uveal Melanoma Study Evaluating Single and Repeated Intravitreal Doses of ICON-1 in Patients With Uveal Melanoma Pembrolizumab in Treating Patients With Advanced Uveal Melanoma Vascular Response to Brachytherapy Using Functional OCT Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma SIR-Spheres® 90Y Microspheres Treatment of Uveal Melanoma Metastasized to Liver Glembatumumab Vedotin in Treating Patients With Metastatic or Locally Recurrent Uveal Melanoma Dexamethasone Intravitreal Implant for Treatment of Macular Edema After Plaque Radiotherapy of Uveal Melanoma Stereotactic Body Radiation Therapy and Aflibercept in Treating Patients With Uveal Melanoma Endoresection of the Tumor Scar or Transpupillary Thermotherapy for the Treatment of Large Uveal Melanomas (Endoresection-Laser) Durvalumab (MEDI4736) Plus Cediranib in Patients With Metastatic Uveal Melanoma A Phase Ib/II Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma Study of AntiCTLA4 in Patients With Unresectable or Metastatic Uveal Melanoma Tilting of Radioactive Plaques After Initial Accurate Placement for Treatment of Uveal Melanoma A Study of the Intra-Patient Escalation Dosing Regimen With IMCgp100 in Patients With Advanced Uveal Melanoma Trametinib With or Without GSK2141795 in Treating Patients With Metastatic Uveal Melanoma RAD001 (Everolimus) and Pasireotide (SOM230) LAR in Patients With Advanced Uveal Melanoma Safety & Activity of Controllable PRAME-TCR Therapy in Previously Treated AML/MDS or Metastatic Uveal Melanoma CAVATAK® and Ipilimumab in Uveal Melanoma Metastatic to the Liver (VLA-024 CLEVER) Comparison Between Fotemustin to Intensive Surveillance in Patients With High Risk Uveal Melanoma Dendritic Cells Plus Autologous Tumor RNA in Uveal Melanoma Study of Immunotherapy Plus ADI-PEG 20 for the Treatment of Advanced Uveal Melanoma New Biopsy Technique for Uveal Melanoma Selumetinib (AZD6244: ARRY-142886) (Hyd-Sulfate) in Metastatic Uveal Melanoma (SUMIT) Safety and Efficacy of AEB071 in Metastatic Uveal Melanoma Patients Influence of Oral Treatment With Citicoline for the Prevention of Radiation Optic Neuropathy in Patients Treated for Uveal Melanomas With Proton Beam Therapy Intermittent Selumetinib for Uveal Melanoma Transarterial Radioembolisation in Comparison to Transarterial Chemoembolisation in Uveal Melanoma Liver Metastasis A Phase I Study of LXS196 in Patients With Metastatic Uveal Melanoma. Evaluation Interest of the Circulating Tumor DNA Dosage in Patient With Hepatic Metastatic Uveal Melanoma Candidate to Complete Resection (ct DNA R0) Messenger Ribonucleic Acid (mRNA) Transfected Dendritic Cell Vaccination in High Risk Uveal Melanoma Patients Study of the Activity of PD-1 Inhibitors in Metastatic Uveal Melanoma A Study of Sorafenib in Patients With Chemonaive Metastatic Uveal Melanoma Crizotinib in High-Risk Uveal Melanoma Following Definitive Therapy Trial of Nivolumab in Combination With Ipilimumab in Subjects With Previously Untreated Metastatic Uveal Melanoma Vorinostat in Patients With Class 2 High Risk Uveal Melanoma Yttrium90, Ipilimumab, & Nivolumab for Uveal Melanoma With Liver Metastases A Phase II Study of BVD-523 in Metastatic Uveal Melanoma Assessing the Clinical Effectiveness of Serum Biomarkers in the Diagnosis of Metastatic Uveal Melanoma Treatment With Intravitreal Avastin for Large Uveal Melanomas

Brief Title

Dexamethasone Intravitreal Implant for Treatment of Macular Edema After Plaque Radiotherapy of Uveal Melanoma

Official Title

Dexamethasone Intravitreal Implant for Treatment of Macular Edema After Plaque Radiotherapy of Uveal Melanoma

Brief Summary

      To evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex) and
      compare it with safety and efficacy of intravitreal bevacizumab in eyes with macular edema
      after plaque radiotherapy of uveal melanoma.
    

Detailed Description

      Plaque radiotherapy is a commonly used method for treatment of small and medium-sized uveal
      melanomas. Macular edema is one of the most common causes of visual loss after plaque
      radiotherapy and has been reported in up to 70% of patients with posterior uveal melanoma.
      Different methods have been proposed for treatment of post-radiation macular edema and
      include periocular steroid, intravitreal steroid, intravitreal vascular endothelial growth
      factor (VEGF) inhibitors, photodynamic therapy, and macular laser photocoagulation.

      Injection of intravitreal triamcinolone (a form of steroid) has been found to be useful for
      treatment of different forms of macular edema but is associated with considerable rates of
      increased intraocular pressure (glaucoma). Dexamethasone is more potent than triamcinolone
      and can be safely injected directly into the vitreous cavity (intravitreal injection) but
      unfortunately its use in the form of intravitreal injection is not practical due to the short
      half-life of intraocular dexamethasone (about 3 hours).

      Within the past several years, tiny drug delivery systems have been developed that allow
      sustained release of minute amounts of steroid into the back part (vitreous cavity) of the
      eye, when they are implanted into the vitreous cavity. Ozurdex is a biodegradable
      dexamethasone intravitreal implant that has been shown to be well-tolerated and effective for
      up to 6 months in reducing vision loss and improving visual outcome in eyes with different
      types of macular edema including those secondary to diabetic retinopathy and retinal vein
      occlusion.

      In this study the investigators would like to evaluate the safety and effectiveness of
      Ozurdex (dexamethasone intravitreal implant) for treatment of macular edema developing after
      plaque radiotherapy of uveal melanoma.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Number of Participants for Whom Study Eye Showed >=2 Lines of Improvement in Best-corrected Visual Acuity

Secondary Outcome

 Change in Central Subfield Retinal Thickness

Condition

Macular Edema

Intervention

Ozurdex

Study Arms / Comparison Groups

 Ozurdex
Description:  Patients will be followed at 1 week after Ozurdex insertion (0.7 mg) and then at 1,2, 3,4, 5, and 6 months. Following the 6-month visit, patients will be seen every 2 months. At each visit patients will be checked for side effects of treatment, measurement of best-corrected visual acuity (BCVA), complete eye examination, fundus photography, and optical coherence tomography. Fluorescein angiography will be repeated at 6 and 12 months. Each eye in the Ozurdex group can have a maximum total of three Ozurdex insertions at minimum of 4-month intervals in the first year after enrolling into the study.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

6

Start Date

April 2014

Completion Date

July 2015

Primary Completion Date

July 2015

Eligibility Criteria

        -  Inclusion criteria:

               1. Patient age 18 years or more.

               2. Uveal melanoma treated with I-125 plaque radiotherapy.

               3. Visual acuity between 20/40 to 20/400 secondary to post-radiation macular edema.

               4. Central subfield retinal thickness > 300 micron.

               5. Duration of macular edema < 12 months.

               6. No potential contributing causes of decreased vision other than macular edema.

          -  Exclusion criteria:

               1. Visual acuity worse than 20/400 or better than 20/40.

               2. Monocular patient or poor vision in the non-study eye (<20/80).

               3. History of vitrectomy surgery.

               4. Panretinal photocoagulation or intraocular surgery within 3 months of enrollment.

               5. Concomitant or previous radiation optic neuropathy.

               6. Use of periocular, intravitreal, or systemic steroids within 6 month of
                  enrollment in the study eye.

               7. Use of intravitreal VEGF antagonist within 6 weeks of enrollment.

               8. History of ocular hypertension or glaucoma, or intraocular pressure (IOP)>21
                  mmHg.

               9. History of steroid-induced glaucoma in either eye.

              10. Active ocular infection or history of herpetic eye infection.

              11. Clinically significant epiretinal membrane in the study eye.

              12. Iris neovascularization in the study eye.

              13. Clinically significant media opacity preventing acquisition of good-quality
                  optical coherence tomography (OCT) in the study eye.

              14. Aphakia or anterior chamber intraocular lens.

              15. Poorly controlled diabetes (Hemoglobin A1c level >13%).

              16. Poorly controlled hypertension (Systolic pressure > 160 mm Hg or diastolic
                  pressure > 90 mm Hg).

              17. Pregnancy (women of childbearing age should have negative pregnancy test and use
                  contraception).

              18. Presence of any ocular condition that in the opinion of one of the investigators
                  will prevent at least 2 lines of improvement in best-corrected visual acuity.

              19. Interval between plaque radiotherapy for uveal melanoma and intended date of
                  dexamethasone intravitreal implant of less than 6 months.

              20. Evidence of activity or inadequate regression of the treated uveal melanoma after
                  plaque radiotherapy (based on the judgment of the study investigators).

              21. Known allergy or hypersensitivity to any of the study medications or their
                  components.

              22. History of prior myocardial infarction or stroke.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Armen Mashayekhi, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01471054

Organization ID

Wills IRB# 11-089


Responsible Party

Sponsor-Investigator

Study Sponsor

Arman Mashayekhi

Collaborators

 Allergan

Study Sponsor

Armen Mashayekhi, MD, Principal Investigator, Wills Eye Hospital IRB Director


Verification Date

August 2019