TerminatedPhase 2

Dexamethasone Intravitreal Implant for Treatment of Macular Edema After Plaque Radiotherapy of Uveal Melanoma

Stopped: Could not enroll enough patients.

United States6 participantsStarted 2014-04

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patient age 18 years or more.
. Uveal melanoma treated with I-125 plaque radiotherapy.
. Visual acuity between 20/40 to 20/400 secondary to post-radiation macular edema.
. Central subfield retinal thickness \> 300 micron.
. Duration of macular edema \< 12 months.
. No potential contributing causes of decreased vision other than macular edema.

Exclusion criteria

. Visual acuity worse than 20/400 or better than 20/40.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants for Whom Study Eye Showed >=2 Lines of Improvement in Best-corrected Visual Acuity

Timeframe: At 12 months

Trial details

NCT IDNCT01471054

SponsorArman Mashayekhi

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-07

Results submitted2017-11-03

View on ClinicalTrials.gov More Macular Edema trials