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