← Back to Clinical Trials
Recruiting NCT06332690

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

Trial Parameters

Condition Diabetic Macular Edema
Sponsor IRCCS Multimedica
Study Type OBSERVATIONAL
Phase N/A
Enrollment 50
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-10-17
Completion 2025-06
Interventions
dexamethasone implant

Brief 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.

Eligibility 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, varicell

Related Trials