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

• Status: Terminated
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arman Mashayekhi
• Collaborator: Allergan
• Treatments: BB 1101; Bevacizumab; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

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.