Macular Edema | Dexamethasone Intravitreal Implant for Treatment of Macular Edema After Plaque Radiotherapy of Uveal Melanoma
Macular Edema research study
What is the primary objective of this study?
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.
Who is eligible to participate?
- 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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Cystoid Macular Edema
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:OzurdexEyes 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.
Drug:BevacizumabEyes 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.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
OzurdexPatients 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.
BevacizumabPatients 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.
Start Date: April 2014
Completed Date: July 2015
Phase: Phase 2
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
Study sponsors, principal investigator, and references
Principal Investigator: Armen Mashayekhi, MD
Lead Sponsor: Arman Mashayekhi
Shields CL, Cater J, Shields JA, Chao A, Krema H, Materin M, Brady LW. Combined plaque radiotherapy and transpupillary thermotherapy for choroidal melanoma: tumor control and treatment complications in 270 consecutive patients. Arch Ophthalmol. 2002 Jul;120(7):933-40.