Dexamethasone Intravitreal Implant in Retinal Vein Occlusion

Completed

• Conditions: Macular Edema, Cystoid
• Interventions: Drug: Intravitreal injection

• Registration Number: NCT03559491
• Lead Sponsor: Università degli Studi dell'Insubria

Brief Summary

Purpose: To evaluate retinal functional improvement by means of visual acuity and retinal sensibility examination after intravitreal dexamethasone implant in patients affected by cystoid macular edema secondary to retinal vein occlusion.

Detailed Description

Cystoid macular edema represents the most important cause of visual impairment after retinal vein occlusion. The etiological factors of this complication are under investigation, from inflammatory cytokines to the breakdown of vascular barrier with increased permeability and diffusion of angiogenic factors. Clinical research developed different drugs and therapeutic strategies to treat and control macular edema, to evaluate the correct timetable and to reach long-term clinical significative results. At now, different experiences have been published with available drugs, from steroids to anti Vascular Endothelial Growth Factor. A debate still remains about the correct approach, the correct combination of drugs (if necessary) and the correct evaluation of drug effectiveness.

In our study, we will evaluate extensive functional recovery and its relation to macular thickness after steroid injection. Considering that visual acuity reflects only foveal function, it may not be sufficient to evaluate the overall function on the macular area. We introduce microperimetry study as a valuable and reproducible tool to create a functional mapping of the entire macula.

Study Timeline

• Study Start: 2015-10
• Primary Completion: 2017-10-01
• Study Completion: 2017-12-31
• Status Verified: 2018-06
• Study First Submitted: 2018-06-05
• Study First Submitted QC: 2018-06-05
• Last Update Submitted: 2018-06-05
• Study First Posted: 2018-06-18
• Last Update Posted: 2018-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Macular Edema Patients	Intravitreal injection	Patients affected by cystoid macular edema (CME) due to retinal vein occlusion of recent onset (less than three months) will be enrolled.

Primary Outcome Measures

Name	Time	Method
Visual acuity	6 months	evaluation of visual acuity
retinal sensibility	6 months	microperimetry evaluation