Ranibizumab Versus Dexamethasone Implant in Diabetic Macular Edema (LED)

G. d'Annunzio University

Status: Completed

Conditions: Diabetic Macular Edema

Treatments: Drug: Dexamethasone intravitreal implant 0.7 mg; Drug: Ranibizumab Injection

Study type: Observational

Funder types: Other

Identifiers

NCT03385382

UChieti

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 19 to 90 years old

Volunteers: No Healthy Volunteers

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)

Trial design

40 participants in 2 patient groups

Dexamethasone group

Description:

Patients with diabetic macular edema receiving dexamethasone

Treatment:

Drug: Dexamethasone intravitreal implant 0.7 mg

ranibizumab

Description:

Patients with diabetic macular edema receiving ranibizumab

Treatment:

Drug: Ranibizumab Injection