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Clinical Trials/NCT03559491
NCT03559491
Completed
Not Applicable

Evaluation of the Effectiveness of Treatment With Dexamethasone Intravitreal Implant in Cystoid Macular Edema Secondary to Retinal Vein Occlusion

Università degli Studi dell'Insubria0 sites30 target enrollmentOctober 2015

Overview

Phase
Not Applicable
Intervention
Intravitreal injection
Conditions
Macular Edema, Cystoid
Sponsor
Università degli Studi dell'Insubria
Enrollment
30
Primary Endpoint
Visual acuity
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2015
End Date
December 31, 2017
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Università degli Studi dell'Insubria
Responsible Party
Principal Investigator
Principal Investigator

Simone Donati

Study Investigator

Università degli Studi dell'Insubria

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Macular Edema Patients

Patients affected by cystoid macular edema (CME) due to retinal vein occlusion of recent onset (less than three months) will be enrolled.

Intervention: Intravitreal injection

Outcomes

Primary Outcomes

Visual acuity

Time Frame: 6 months

evaluation of visual acuity

retinal sensibility

Time Frame: 6 months

microperimetry evaluation

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