Dexamethasone Intravitreal Implant in Retinal Vein Occlusion

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

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.

Study Overview

• Status: Completed
• Conditions: Macular Edema, Cystoid
• Intervention / Treatment: Drug: Intravitreal injection

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 Type: Observational
• Enrollment (Actual): 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion criteria were: age older than 18 years; CME secondary to retinal vein occlusion, disease duration inferior to 12 weeks; best-corrected visual acuity (BCVA) between 20/200 and 20/25 (Snellen equivalent) in the study eye at baseline examination, central retinal thickness (CRT) superior to 300 mm, as measured by optical coherence tomography at baseline examination.

The exclusion criteria were any ocular surgery in the study eye in the past 6 months; diabetes mellitus with signs of diabetic retinopathy; previous laser photocoagulation; previous intravitreal injection of corticosteroids or anti-vascular endothelial growth factor; a history of ocular inflammation; marked retinal ischemia or retinal hemorrhages (in particular in macular region involving the fovea); any other ocular condition such as anterior ischemic neuropathy, amblyopia or significant media opacities; significant alteration on epiretinal surface such as epiretinal membrane or vitreomacular traction; uncontrolled or advanced glaucoma; any uncontrolled systemic disease.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Intravitreal injection; Long term release steroid injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity	evaluation of visual acuity	6 months
retinal sensibility	microperimetry evaluation	6 months

Collaborators and Investigators

• Sponsor: Università degli Studi dell'Insubria
• Investigators: Principal Investigator: Simone Donati, MD, Università dell'Insubria

Publications and helpful links

General Publications

• Querques G, Lattanzio R, Querques L, Triolo G, Cascavilla ML, Cavallero E, Del Turco C, Casalino G, Bandello F. Impact of intravitreal dexamethasone implant (Ozurdex) on macular morphology and function. Retina. 2014 Feb;34(2):330-41. doi: 10.1097/IAE.0b013e31829f7495.
• Garweg JG, Zandi S. Impact of treatment on long-term visual function in retinal vein occlusion-response to the comment on: retinal vein occlusion and the use of a dexamethasone intravitreal implant (Ozurdex(R)) in its treatment. Graefes Arch Clin Exp Ophthalmol. 2016 Dec;254(12):2479-2480. doi: 10.1007/s00417-016-3459-y. Epub 2016 Sep 7. No abstract available.
• Donati S, Gandolfi C, Caprani SM, Cattaneo J, Premoli L, Azzolini C. Evaluation of the Effectiveness of Treatment with Dexamethasone Intravitreal Implant in Cystoid Macular Edema Secondary to Retinal Vein Occlusion. Biomed Res Int. 2018 Aug 2;2018:3095961. doi: 10.1155/2018/3095961. eCollection 2018.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: June 5, 2018
• First Submitted That Met QC Criteria: June 5, 2018
• First Posted (Actual): June 18, 2018

Study Record Updates

• Last Update Posted (Actual): June 18, 2018
• Last Update Submitted That Met QC Criteria: June 5, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: macular edema; steroid; retinal vein occlusion
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Retinal Degeneration; Retinal Diseases; Embolism and Thrombosis; Venous Thrombosis; Thrombosis; Macular Degeneration; Macular Edema; Retinal Vein Occlusion; Edema
• Other Study ID Numbers: 2018oculistica

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No