Dexamethasone Intravitreal Implant for Treatment of Macular Edema After Plaque Radiotherapy of Uveal Melanoma
Condition: Macular Edema; Cystoid Macular Edema; Uveal Melanoma; Radiation Maculopathy; Radiation Retinopathy
MeSH terms: Melanoma; Uveal Neoplasms; Macular Edema; Retinal Diseases; Macular Degeneration; Edema
Intervention: Ozurdex; Bevacizumab
Intervention description: 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.; 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.
Intervention MeSH terms: Dexamethasone; Bevacizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Plaque radiotherapy; Brachytherapy; Macular edema; Cystoid macular edema; Uveal melanoma; Radiation maculopathy; Radiation retinopathy; Ozurdex; Dexamethasone intravitreal implant

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.
    

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.