Ranibizumab Versus Dexamethasone Implant in Diabetic Macu... | NCT03385382

Studies
Ranibizumab Versus Dexamethasone Implant in Diabetic Macular Edema

NCT03385382

Sponsor

G. d'Annunzio University

Status

Completed

Last Update Posted

Jan 2, 2018Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Diabetic Macular Edema

Interventions

Dexamethasone intravitreal implant 0.7 mg
Ranibizumab Injection

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 6, 2016Actual

Primary Completion Date

Jun 27, 2017Actual

Completion Date

Jun 27, 2017Actual

First Submitted Date

Dec 20, 2017

First Submission Date that Met QC Criteria

Dec 20, 2017

First Posted Date

Dec 28, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 29, 2017

Last Update Posted Date

Jan 2, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dexamethasone group		Patients with diabetic macular edema receiving dexamethasone	Drug: Dexamethasone intravitreal implant 0.7 mg
ranibizumab		Patients with diabetic macular edema receiving ranibizumab	Drug: Ranibizumab Injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexamethasone intravitreal implant 0.7 mg	Drug	Intravitreal Implant of dexamethasone	Dexamethasone group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

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

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Yes by request to the investigator via email

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003907	Dexamethasone
D000069579	Ranibizumab

Ancestor Terms

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids

Browse Leaves

Not provided

Browse Branches

Not provided