Suspended

Medium Choroidal Melanoma: Enucleation vs. Iodine-125 Episcleral Plaque Irradiation

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What is being tested

Data Collection

Who is being recruted

Uveal Melanoma+14

+ Choroid Neoplasms

+ Eye Diseases

Over 21 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: November 1986
See protocol details

Summary

Principal SponsorNational Eye Institute (NEI)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 1986

Actual date on which the first participant was enrolled.

For over a century, the standard treatment for choroidal melanoma, a type of eye cancer, has been the removal of the eye. However, interest in radiation therapy grew as it potentially allows patients to keep their eye and some vision. The Collaborative Ocular Melanoma Study (COMS), started in 1986, aims to compare the effectiveness of radiation therapy and eye removal in prolonging the life of patients with choroidal melanoma. This study is important as it could provide a new standard for treating this condition, potentially improving patients' quality of life and addressing current challenges. In the COMS study, patients with medium-sized tumors are randomly assigned to either eye removal or radiation therapy using an iodine-125 episcleral plaque. For those assigned to eye removal, the procedure follows a standard method. For those receiving radiation, a gold plaque containing radioactive iodine seeds is attached to the outside of the eye, delivering a high dose of radiation to the tumor. The plaque is typically removed after three to seven days. Enrollment for this trial ended in July 1998 with 1,317 patients. In another trial, patients with large tumors receive either eye removal or eye removal preceded by external beam radiation. Enrollment for this trial ended in December 1994 with 1,003 patients. The study is conducted across 43 clinical centers in the United States and Canada, and outcomes measured include time to death from all causes, time to death from cancer, diagnosis of other tumors, complications of radiation, and changes in visual acuity.

Official TitleCollaborative Ocular Melanoma Study (COMS)
Principal SponsorNational Eye Institute (NEI)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Uveal MelanomaChoroid NeoplasmsEye DiseasesEye NeoplasmsMelanomaNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueUveal DiseasesUveal NeoplasmsUveitisChoroid DiseasesNeuroectodermal TumorsNevi and MelanomasNeuroendocrine Tumors

Criteria

Men and women eligible for the study must be age 21 or older, have primary choroidal melanoma in only one eye, and have no evidence of metastatic disease. Accurate estimation of tumor thickness by echography must also be possible.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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SuspendedNo study centers