Dexamethasone Intravitreal Implant for Treatment of Macular Edema After Plaque Radiotherapy of Uveal Melanoma
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ClinicalTrials.gov Identifier: NCT01471054 |
Recruitment Status
:
Terminated
(Could not enroll enough patients.)
First Posted
: November 11, 2011
Last Update Posted
: December 12, 2016
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Condition or disease | Intervention/treatment | Phase |
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Macular Edema Cystoid Macular Edema Uveal Melanoma Radiation Maculopathy Radiation Retinopathy | Drug: Ozurdex Drug: Bevacizumab | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 6 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Dexamethasone Intravitreal Implant for Treatment of Macular Edema After Plaque Radiotherapy of Uveal Melanoma |
Study Start Date : | April 2014 |
Actual Primary Completion Date : | July 2015 |
Actual Study Completion Date : | July 2015 |

Arm | Intervention/treatment |
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Experimental: Ozurdex
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 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.
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Drug: Ozurdex
Eyes in the Ozurdex group can have a maximum total of three Ozurdex insertions in the first 12 months after enrolling into the study. The criteria for retreatment with Ozurdex are: i.The study eye must have shown initial favorable response to prior Ozurdex implant (>10% decrease in central macular thickness with maintenance [change in BCVA of <=1 line] or improvement of visual acuity [increase of BCVA of >1 line]) ii. Interval since last Ozurdex implant should be > 4 and < 12 months. iii. The study eye must show definite evidence of recurrence of macular edema. Other Name: Dexamethasone intravitreal implant
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Active Comparator: Bevacizumab
Patients will be followed at 1 week after the initial bevacizumab injection and then at 1,2, 3,4, 5, and 6 months after implant. Following the 6-month visit, the patients will be examined every 4-8 weeks depending on the status of their macular edema. At each visit patients will be checked for side effects of treatment, measurement of BCVA, complete eye examination, fundus photography, and optical coherence tomography. Fluorescein angiography will be repeated at 6 and 12 months. Eyes in the Bevacizumab group can have a maximum total of twelve (12) bevacizumab injections at minimum of 4-week intervals in the first year after enrolling into the study.
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Drug: Bevacizumab
Eyes in the Bevacizumab group can have a maximum total of twelve bevacizumab injections in the first year after enrolling into the study. All patients will receive 6 monthly injections after entering the study. After the sixth injection (at month 5) the interval between injections will be extended to 6 weeks if the study eye has shown initial favorable response to prior intravitreal bevacizumab.
Other Name: Avastin
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- Proportion of eyes showing >=2 lines of improvement in best-corrected visual acuity [ Time Frame: At 12 months ]
- Change in central subfield retinal thickness [ Time Frame: At 12 months ]
- Development of glaucoma [ Time Frame: At 12 months ]
- Development of cataract [ Time Frame: At 12 months ]
- Development of retinal detachment [ Time Frame: At 12 months ]
- Development of vitreous hemorrhage [ Time Frame: At 12 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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Inclusion criteria:
- Patient age 18 years or more.
- Uveal melanoma treated with I-125 plaque radiotherapy.
- Visual acuity between 20/40 to 20/400 secondary to post-radiation macular edema.
- Central subfield retinal thickness > 300 micron.
- Duration of macular edema < 12 months.
- No potential contributing causes of decreased vision other than macular edema.
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Exclusion criteria:
- Visual acuity worse than 20/400 or better than 20/40.
- Monocular patient or poor vision in the non-study eye (<20/80).
- History of vitrectomy surgery.
- Panretinal photocoagulation or intraocular surgery within 3 months of enrollment.
- Concomitant or previous radiation optic neuropathy.
- Use of periocular, intravitreal, or systemic steroids within 6 month of enrollment in the study eye.
- Use of intravitreal VEGF antagonist within 6 weeks of enrollment.
- History of ocular hypertension or glaucoma, or IOP>21 mmHg.
- History of steroid-induced glaucoma in either eye.
- Active ocular infection or history of herpetic eye infection.
- Clinically significant epiretinal membrane in the study eye.
- Iris neovascularization in the study eye.
- Clinically significant media opacity preventing acquisition of good-quality OCT in the study eye.
- Aphakia or anterior chamber intraocular lens.
- Poorly controlled diabetes (Hemoglobin A1c level >13%).
- Poorly controlled hypertension (Systolic pressure > 160 mm Hg or diastolic pressure > 90 mm Hg).
- Pregnancy (women of childbearing age should have negative pregnancy test and use contraception).
- 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.
- Interval between plaque radiotherapy for uveal melanoma and intended date of dexamethasone intravitreal implant of less than 6 months.
- Evidence of activity or inadequate regression of the treated uveal melanoma after plaque radiotherapy (based on the judgment of the study investigators).
- Known allergy or hypersensitivity to any of the study medications or their components.
- History of prior myocardial infarction or stroke.

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): NCT01471054
United States, Pennsylvania | |
Ocular Oncology Service, Wills Eye Institute | |
Philadelphia, Pennsylvania, United States, 19107 |
Principal Investigator: | Armen Mashayekhi, MD | Wills Eye Hospital IRB Director |
Publications:
Responsible Party: | Arman Mashayekhi, Principal Investigator, Assistant Professor, Wills Eye |
ClinicalTrials.gov Identifier: | NCT01471054 History of Changes |
Other Study ID Numbers: |
Wills IRB# 11-089 |
First Posted: | November 11, 2011 Key Record Dates |
Last Update Posted: | December 12, 2016 |
Last Verified: | December 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Keywords provided by Arman Mashayekhi, Wills Eye:
Plaque radiotherapy Brachytherapy Macular edema Cystoid macular edema Uveal melanoma |
Radiation maculopathy Radiation retinopathy Ozurdex Dexamethasone intravitreal implant |
Additional relevant MeSH terms:
Melanoma Edema Macular Edema Retinal Diseases Uveal Neoplasms Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Signs and Symptoms Macular Degeneration Retinal Degeneration |
Eye Diseases Eye Neoplasms Neoplasms by Site Uveal Diseases Dexamethasone acetate Dexamethasone Bevacizumab BB 1101 Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids |