NCT00441662

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

March 1, 2007

Status Verified

February 1, 2007

First QC Date

February 28, 2007

Last Update Submit

February 28, 2007

Conditions

Melanoma

Keywords

MelanomaUveaMaculaEdemaPlaque radiotherapyBrachytherapyTriamcinolone

Outcome Measures

Primary Outcomes (1)

  • Presence of macular edema on optical coherence tomography

Secondary Outcomes (3)

  • Grade of macular edema on optical coherence tomography

  • Foveal thickness measurement by optical coherence tomography

  • Visual acuity

Interventions

Sub-Tenon triamcinolone 40mgDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Uveal melanoma new diagnosis, undergoing plaque radiation treatment

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ocular Oncology Service, Wills Eye Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (3)

  • Shields 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: 9599365BACKGROUND

  • Shields 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: 10980767BACKGROUND

  • 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. doi: 10.1001/archopht.120.7.933.

    PMID: 12096964BACKGROUND

Related Links

MeSH Terms

Conditions

MelanomaEdema

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Carol L Shields, M.D.

    Ocular Oncology Service, Wills Eye Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 28, 2007

First Posted

March 1, 2007

Study Start

November 1, 2004

Study Completion

May 1, 2007

Last Updated

March 1, 2007

Record last verified: 2007-02

Locations

US(1)