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OCT and OCT-Angiography Biomarkers of Treatment Response to Dexamethasone Implant in Macular Edema Due to Retinal Vascular Diseases - DME and RVO
RECRUITINGSponsored by IRCCS Multimedica
Actively Recruiting
SponsorIRCCS Multimedica
Started2023-10-17
Est. completion2025-06
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06332690
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
Age: 18 Years+Healthy volunteers accepted
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
Conditions4
DiabetesDiabetic Macular EdemaMacular Edema Due to Diabetes MellitusRetinal Vein Occlusion
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Actively Recruiting
SponsorIRCCS Multimedica
Started2023-10-17
Est. completion2025-06
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06332690