Clinical trial · Interventional
Dexamethasone Intravitreal Implant for Treatment of Macular Edema After Plaque Radiotherapy of Uveal Melanoma
NCT01471054CI-TRIAL-00040365terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Could not enroll enough patients.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cystoid Macular Edema | — | UNRESOLVED | — |
| Macular Edema | — | UNRESOLVED | — |
| Radiation Maculopathy | — | UNRESOLVED | — |
| Radiation Retinopathy | — | UNRESOLVED | — |
| Uveal Melanoma | Uveal Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Ozurdex | Drug | Dexamethasone | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 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.
- interventionNames
- Drug: Ozurdex
- type
- ACTIVE_COMPARATOR
- label
- Bevacizumab
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* 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.
References
Publications (14)
- BACKGROUNDShields 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. doi: 10.1001/archopht.120.7.933. PMID 12096964
- BACKGROUNDHorgan N, Shields CL, Mashayekhi A, Teixeira LF, Materin MA, Shields JA. Early macular morphological changes following plaque radiotherapy for uveal melanoma. Retina. 2008 Feb;28(2):263-73. doi: 10.1097/IAE.0b013e31814b1b75. PMID 18301032
- BACKGROUNDHorgan N, Shields CL, Mashayekhi A, Salazar PF, Materin MA, O'Regan M, Shields JA. Periocular triamcinolone for prevention of macular edema after plaque radiotherapy of uveal melanoma: a randomized controlled trial. Ophthalmology. 2009 Jul;116(7):1383-90. doi: 10.1016/j.ophtha.2009.01.051. Epub 2009 May 30. PMID 19481812
- BACKGROUNDSutter FK, Gillies MC. Intravitreal triamcinolone for radiation-induced macular edema. Arch Ophthalmol. 2003 Oct;121(10):1491-3. doi: 10.1001/archopht.121.10.1491. No abstract available. PMID 14557194
- BACKGROUNDGupta A, Muecke JS. Treatment of radiation maculopathy with intravitreal injection of bevacizumab (Avastin). Retina. 2008 Jul-Aug;28(7):964-8. doi: 10.1097/IAE.0b013e3181706302. PMID 18698298
- BACKGROUNDBakri SJ, Beer PM. Photodynamic therapy for maculopathy due to radiation retinopathy. Eye (Lond). 2005 Jul;19(7):795-9. doi: 10.1038/sj.eye.6701637. PMID 15359269
- BACKGROUNDHykin PG, Shields CL, Shields JA, Arevalo JF. The efficacy of focal laser therapy in radiation-induced macular edema. Ophthalmology. 1998 Aug;105(8):1425-9. doi: 10.1016/S0161-6420(98)98023-X. PMID 9709753