Ranibizumab Versus Dexamethasone Implant in Diabetic Macular Edema

Diabetic Macular Edema Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03385382
• Other study ID #: UChieti
• Status: Completed
• Phase: N/A
• First received: December 20, 2017
• Last updated: December 29, 2017
• Start date: December 6, 2016
• Est. completion date: June 27, 2017

Study information

• Verified date: December 2017
• Source: G. d'Annunzio University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 27, 2017
• Est. primary completion date: June 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• Dexamethasone intravitreal implant 0.7 mg
Intravitreal Implant of dexamethasone
• Ranibizumab Injection
Injection of ranibizumab

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
G. d'Annunzio University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central macular thickness	Decrease of macular thickness	6 months
Secondary	visual acuity	Increase of mean visual acuity	6 months