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

This study has been terminated.
(Could not enroll enough patients.)
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Arman Mashayekhi, Wills Eye
ClinicalTrials.gov Identifier:
NCT01471054
First received: November 4, 2011
Last updated: December 9, 2016
Last verified: December 2016
  Purpose
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.

Condition Intervention Phase
Macular Edema Cystoid Macular Edema Uveal Melanoma Radiation Maculopathy Radiation Retinopathy Drug: Ozurdex Drug: Bevacizumab Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dexamethasone Intravitreal Implant for Treatment of Macular Edema After Plaque Radiotherapy of Uveal Melanoma

Resource links provided by NLM:


Further study details as provided by Arman Mashayekhi, Wills Eye:

Primary Outcome Measures:
  • Proportion of eyes showing >=2 lines of improvement in best-corrected visual acuity [ Time Frame: At 12 months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 6
Study Start Date: April 2014
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01471054

Locations
United States, Pennsylvania
Ocular Oncology Service, Wills Eye Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Arman Mashayekhi
Allergan
Investigators
Principal Investigator: Armen Mashayekhi, MD Wills Eye Hospital IRB Director
  More Information

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
Study First Received: November 4, 2011
Last Updated: December 9, 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

ClinicalTrials.gov processed this record on July 24, 2017