Ranibizumab Versus Dexamethasone Implant in Diabetic Macular Edema

NCT ID: NCT03385382

Last Updated: 2018-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-06

Study Completion Date

2017-06-27

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetic Macular Edema

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Dexamethasone group

Patients with diabetic macular edema receiving dexamethasone

Dexamethasone intravitreal implant 0.7 mg

Intervention Type DRUG

Intravitreal Implant of dexamethasone

ranibizumab

Patients with diabetic macular edema receiving ranibizumab

Ranibizumab Injection

Intervention Type DRUG

Injection of ranibizumab

Interventions

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Dexamethasone intravitreal implant 0.7 mg

Intravitreal Implant of dexamethasone

Intervention Type DRUG

Ranibizumab Injection

Injection of ranibizumab

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

19 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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G. d'Annunzio University

OTHER

Sponsor Role lead

Responsible Party

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LISA TOTO

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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UChieti

Identifier Type: -

Identifier Source: org_study_id

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