UnknownNot Applicable

OCT and OCT-Angiography Biomarkers of Treatment Response to Dexamethasone Implant in Macular Edema Due to Retinal Vascular Diseases - DME and RVO

Italy50 participantsStarted 2023-10-17

Plain-language summary

The purpose of this pilot study is to evaluate different imaging parameters in patients with previously treatment-naive DME and ME due to RVO before and after treatment with dexamethasone implant, in order to find specific retinal inflammatory and microvascular biomarkers that may be predictive of treatment outcome.

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: * previously untreated centre-involving DME or ME secondary to RVO with CMT ≥ 300 μm; * pseudophakic eyes or eyes with a transparent lens or only initial sclerosis of the lens, in order to obtain good quality retinal imaging * patient agreement to participate in the study. Exclusion Criteria: * any retinal disease other than DR or RVO; * a positive history of retinal surgery and/or any other macular/retinal treatment (laser, intravitreal injections of anti-VEGF and/or steroids); * cataract surgery within 6 months in the study eye; * refractive error \> +/- 4D; * Advanced glaucoma * neurodegenerative diseases (e.g. multiple sclerosis, Alzheimer disease, Parkinson disease, etc.) * poor quality of OCT and/or OCT-A images due to significant media opacity or poor patient cooperation. * Ocular or periocular infections (including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases * Non-intact posterior lens capsule * Hypersensitivity to any component of the product

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

Modification of inflammatory biomarkers on OCT and perfusion density parameters on OCT-A at 4 months after surgery (Change measure)

Timeframe: pre-surgery and at 4 months after each surgery (if applicable)

Trial details

NCT IDNCT06332690

SponsorIRCCS Multimedica

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-06

Contact for this trial

Stela Vujosevic, MD

+30 02 85 99 4601 stela.vujosevic@multimedica.it

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