Ranibizumab Versus Dexamethasone Implant in Diabetic Macular Edema (LED)

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Macular Edema
• Intervention / Treatment: Drug: Dexamethasone intravitreal implant 0.7 mg; Drug: Ranibizumab Injection

• Study Type: Observational
• Enrollment (Actual): 40

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with no proliferative moderate DR stage (simplified version of the ETDRS classification aimed by the American Academy of Ophthalmology Guidelines Committe) and cystoid macular edema type without subretinal fluid component were recruited

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Dexamethasone group; Patients with diabetic macular edema receiving dexamethasone	Drug: Dexamethasone intravitreal implant 0.7 mg; Intravitreal Implant of dexamethasone
ranibizumab; Patients with diabetic macular edema receiving ranibizumab	Drug: Ranibizumab Injection; Injection of ranibizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Central macular thickness	Decrease of macular thickness	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual acuity	Increase of mean visual acuity	6 months

Collaborators and Investigators

• Sponsor: G. d'Annunzio University

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2016
• Primary Completion (Actual): June 27, 2017
• Study Completion (Actual): June 27, 2017

Study Registration Dates

• First Submitted: December 20, 2017
• First Submitted That Met QC Criteria: December 20, 2017
• First Posted (Actual): December 28, 2017

Study Record Updates

• Last Update Posted (Actual): January 2, 2018
• Last Update Submitted That Met QC Criteria: December 29, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Dexamethasone; Ranibizumab
• Other Study ID Numbers: UChieti

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Yes by request to the investigator via email

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No