Ranibizumab Versus Dexamethasone Implant in Diabetic Macular Edema

Between December 2016 and June 2017 a total of 40 eyes from 40 diabetic retinopathy patients with diabetic macular edema were recruited at the Ophthalmologic Clinic of University "G. d'Annunzio", Chieti-Pescara, Italy.

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Key information

Conditions

Diabetic Macular Edema

Age range

19 year–90 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age >18 years old
BCVA greater than 0.5 LogMAR in the study eye at baseline examination
Presence of recent DME
CMT > 300µm as measured using the SD-OCT at the baseline examination

Exclusion criteria

Any previous ocular surgery in the last 6 months
Laser treatments
Prior ocular trauma
Retinal vascular diseases
Vitreo-retinal interface diseases
Medium lens opacities (according to Lens Opacities Classification System)

Treatment and study plan

dexamethasone intravitreal implant 0.7 mg

Drug

Intravitreal Implant of dexamethasone

Ranibizumab Injection

Drug

Injection of ranibizumab

Primary outcomes

Central macular thickness

Time frame: 6 months

Decrease of macular thickness

Secondary outcomes

visual acuity

Time frame: 6 months

Increase of mean visual acuity

Sponsors and collaborators

Lead sponsor

G. d'Annunzio University

Other

Registry information

Official study title

Macular Thickness and Vessel Density Changes After Dexamethasone Implant and Ranibizumab Intravitreal Injection in Diabetic Macular Edema: 6-month Follow-up

Acronym: LED

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Dec 28, 2017
Registry last updated: Jan 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed