NCT03385382

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 6, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 28, 2017

Completed
Last Updated

January 2, 2018

Status Verified

December 1, 2017

Enrollment Period

7 months

First QC Date

December 20, 2017

Last Update Submit

December 29, 2017

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

  • Central macular thickness

    Decrease of macular thickness

    6 months

Secondary Outcomes (1)

  • visual acuity

    6 months

Study Arms (2)

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

Dexamethasone intravitreal implant 0.7 mgDRUG

Intravitreal Implant of dexamethasone

Dexamethasone group
Ranibizumab InjectionDRUG

Injection of ranibizumab

ranibizumab

Eligibility Criteria

Age19 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

DexamethasoneRanibizumab

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

December 20, 2017

First Posted

December 28, 2017

Study Start

December 6, 2016

Primary Completion

June 27, 2017

Study Completion

June 27, 2017

Last Updated

January 2, 2018

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Yes by request to the investigator via email