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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03559491
Enrollment
30
Registered
2018-06-18
Start date
2015-10-31
Completion date
2017-12-31
Last updated
2018-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Edema, Cystoid

Keywords

steroid, retinal vein occlusion, macular edema

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.

Interventions

DRUGIntravitreal injection

Long term release steroid injection

Sponsors

Università degli Studi dell'Insubria
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Visual acuity6 monthsevaluation of visual acuity
retinal sensibility6 monthsmicroperimetry evaluation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026