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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
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Arman Mashayekhi, Wills Eye

November 4, 2011
November 11, 2011
December 12, 2016
April 2014
July 2015   (Final data collection date for primary outcome measure)
Proportion of eyes showing >=2 lines of improvement in best-corrected visual acuity [ Time Frame: At 12 months ]
Same as current
Complete list of historical versions of study NCT01471054 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Dexamethasone Intravitreal Implant for Treatment of Macular Edema After Plaque Radiotherapy of Uveal Melanoma
Dexamethasone Intravitreal Implant for Treatment of Macular Edema After Plaque Radiotherapy of Uveal Melanoma
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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Macular Edema
  • Cystoid Macular Edema
  • Uveal Melanoma
  • Radiation Maculopathy
  • Radiation Retinopathy
  • 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
  • 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
  • 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.
    Intervention: Drug: Ozurdex
  • 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.
    Intervention: Drug: Bevacizumab

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
6
20
July 2015
July 2015   (Final data collection date for primary outcome measure)
  • 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01471054
Wills IRB# 11-089
No
Not Provided
Plan to Share IPD: Undecided
Arman Mashayekhi, Wills Eye
Arman Mashayekhi
Allergan
Principal Investigator: Armen Mashayekhi, MD Wills Eye Hospital IRB Director
Wills Eye
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP