Evaluating imaging biomarkers for treatment response in macular edema
Imaging Biomarkers of Treatment Response to Dexamethasone Implant in Macular Edema Due to Retinal Vascular Diseases - Diabetic Macular Edema and Retinal Vein Occlusion.
IRCCS Multimedica · NCT06332690
This study is trying to see if certain eye scans can help predict how well a new treatment works for people with diabetic macular edema and macular edema from retinal vein occlusion.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Multimedica (other) |
| Locations | 1 site (Milan) |
| Trial ID | NCT06332690 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess various imaging parameters in patients with treatment-naive diabetic macular edema (DME) and macular edema due to retinal vein occlusion (RVO) before and after treatment with a dexamethasone implant. The focus is on identifying specific retinal inflammatory and microvascular biomarkers that may predict treatment outcomes. By understanding the role of inflammation in these conditions, the study seeks to improve therapeutic strategies beyond current anti-VEGF treatments.
Who should consider this trial
Good fit: Ideal candidates include individuals with previously untreated center-involving DME or ME secondary to RVO with central macular thickness (CMT) of 300 μm or greater.
Not a fit: Patients with other retinal diseases, a history of retinal surgery, or significant ocular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for patients with macular edema.
How similar studies have performed: While the role of inflammation in macular edema is recognized, this specific approach to identifying biomarkers in response to dexamethasone treatment is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Milan
- MultiMedica IRCCS Multimedica — Milan, Italy (RECRUITING)
Study contacts
- Principal investigator: Stela Vujosevic, MD — MultiMedica - IRCCS MultiMedica
- Study coordinator: Stela Vujosevic, MD
- Email: stela.vujosevic@multimedica.it
- Phone: +30 02 85 99 4601
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetic Macular Edema, Macular Edema Due to Diabetes Mellitus, Retinal Vein Occlusion, Diabetic macular edema, macular edema due to retinal vein occlusion, diabetes mellitus, retinal imaging