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

Launched by IRCCS MULTIMEDICA · Mar 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how well a treatment called dexamethasone implant works for patients with diabetic macular edema (DME) and macular edema caused by retinal vein occlusion (RVO). The goal is to use special imaging techniques to look for signs in the retina that might predict how well patients respond to this treatment. Researchers want to learn more about these signs before and after the treatment is given.

To be eligible for the trial, participants need to have DME or RVO that affects the center of their vision and have not received any previous treatment for these conditions. They should also have a clear lens in their eye to allow for good imaging. Participants will be closely monitored to see how their eyes respond to the treatment. It’s important to note that certain conditions, like advanced glaucoma or recent eye surgeries, may prevent someone from joining the study. Overall, this trial could help improve how future treatments are chosen for patients with these eye conditions.

Gender

ALL

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, varicella, mycobacterial infections, and fungal diseases
• • Non-intact posterior lens capsule
• • Hypersensitivity to any component of the product