Clinical trial · Interventional
Sub-Tenon Triamcinolone in the Prevention of Radiation-Induced Macular Edema
Sub-Tenon Triamcinolone in the Prevention of Radiation-Induced Macular Edema Following Plaque Radiotherapy for Uveal Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Melanoma is the most common primary tumour which occurs inside the eye. For over 20-years, it has been possible, in many cases, to use local delivery of radiation to the eye to treat this type of tumour, avoiding the need to surgically remove the affected eye. This treatment, however, is often complicated by radiation-induced loss of vision, months or years after treatment. The aim of this research project is to investigate the potential prevention of radiation complications in the eye by giving anti-inflammatory medication (a long-acting steroid) in the form of a local injection around the eye at the time of treatment, and at 4-months and 8-months following treatment. This medication (named 'triamcinolone') has been successfully used to treat similar complications of diabetic eye disease, for example, and has a good safety profile. The rationale of this study is to attempt to preserve vision, in addition to preserving the eye, in patients affected by this eye tumour, and therefore preserve quality of life for these patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sub-Tenon triamcinolone 40mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Presence of macular edema on optical coherence tomography
Secondary outcomes (3)
- measure
- Grade of macular edema on optical coherence tomography
- measure
- Foveal thickness measurement by optical coherence tomography
- measure
- Visual acuity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Uveal melanoma new diagnosis, undergoing plaque radiation treatment Exclusion Criteria: * Pre-existing macular disease * age-related macular degeneration * diabetic maculopathy * pre-existing retinal vascular occlusion * macular hole * surface wrinkling retinopathy * prior retinal detachment * media opacities precluding accurate OCT imaging * known 'steroid responder' * glaucoma
References
Publications (3)
- BACKGROUNDShields CL, Shields JA, Gunduz K, Freire JE, Mercado G. Radiation therapy for uveal malignant melanoma. Ophthalmic Surg Lasers. 1998 May;29(5):397-409. PMID 9599365
- BACKGROUNDShields CL, Shields JA, Cater J, Gunduz K, Miyamoto C, Micaily B, Brady LW. Plaque radiotherapy for uveal melanoma: long-term visual outcome in 1106 consecutive patients. Arch Ophthalmol. 2000 Sep;118(9):1219-28. doi: 10.1001/archopht.118.9.1219. PMID 10980767
- 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