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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

NCT06332690 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2024-03-27

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

dexamethasone implant

Intravitreal dexamethasone implant (Dex) slowly releases steroids into the vitreous over a period of up to 6 months. Dex 0.7 mg (Ozurdex™; Allergan, Irvine, CA, USA) has been used to reduce ME in patients with DR and RVO and its efficacy in terms of best corrected visual acuity (BCVA) improvement and central macular thickness (CMT) reduction has been demonstrated in many different studies.

Sponsors & Collaborators

  • AbbVie

    collaborator INDUSTRY

  • IRCCS Multimedica

    lead OTHER

Principal Investigators

  • Stela Vujosevic, MD · MultiMedica - IRCCS MultiMedica

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-17
Primary Completion
2025-06-30
Completion
2025-12-31

Countries

  • Italy

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06332690 on ClinicalTrials.gov