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Could a tiny implant save sight in eye cancer patients?

NCT ID NCT04082962

Symptom relief Sponsor: Ivana K. Kim Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tested a single dexamethasone implant (Ozurdex) in 10 people with uveal melanoma who had fluid buildup under the retina after radiation treatment. The goal was to see if the implant is safe and can help reduce the fluid to prevent vision loss. The implant is already FDA-approved for other eye conditions but not yet for this use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

10 people

The number who actually took part.

Started

Dec 2018

Finished

Dec 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Tumor thickness \<= 10 mm. * Associated serous retinal detachment extending beyond tumor, \> two clockhours in extent. * Primary treatment of ocular melanoma with proton irradiation or plaque radiotherapy. Exclusion Criteria: * Any pre-existing glaucoma. * History of elevated IOP (\> 25 mm Hg). * History of steroid response glaucoma. * Active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva: active ocular herpes simplex, active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases. * Any history of ocular herpes simplex. * Torn or ruptured posterior lens capsule. * Known hypersensitivity to any components of the dexamethasone intravitreal implant. * Women of child-bearing potential: pregnant or planning to become pregnant.

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Conditions

The condition(s) this trial relates to.

retinal detachment uveal melanoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Exudative retinal detachment and uveal melanoma

Contacts and locations

Locations

  • Anne Marie Lane

    Boston, Massachusetts, 02114, United States