NCT02623673

Brief Summary

Retrospective cases series is a non-randomized, open-label, single-center investigation (Retina Clinic, São Paulo, Brazil) of patients diagnosed with macular edema secondary to diabetic retinopathy (DME) and retinal vein occlusions who underwent to simultaneous treatment with intravitreal injection of bevacizumab 1.25mg and implant of dexamethasone 0.7mg.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

September 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 8, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

February 17, 2016

Status Verified

February 1, 2016

Enrollment Period

3 months

First QC Date

December 3, 2015

Last Update Submit

February 14, 2016

Conditions

Macular Edema

Outcome Measures

Primary Outcomes (1)

  • Improvement in BCVA

    6 months

Study Arms (1)

bevacizumab plus dexamethasone 0.7mg

simultaneous treatment with intravitreal injection of bevacizumab 1.25mg and intravitreal implant of dexamethasone 0.7mg

Drug: simultaneous treatment with intravitreal injection of bevacizumab 1.25mg and intravitreal implant of dexamethasone 0.7mg.

Interventions

simultaneous treatment with intravitreal injection of bevacizumab 1.25mg and intravitreal implant of dexamethasone 0.7mg.DRUG
bevacizumab plus dexamethasone 0.7mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with macular edema

You may qualify if:

  • central macular thickness \> 300 µm on optical coherence tomography (OCT)
  • macular edema secondary to diabetic retinopathy (DME) and retinal vein occlusions

You may not qualify if:

  • intravitreal anti-VEGF within 6 weeks
  • treatment with laser or intravitreal corticosteroids within 3 months of study entry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Retina Clinic / UNIFESP

São Paulo, São Paulo, 06010-130, Brazil

Location

MeSH Terms

Conditions

Macular Edema

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gabriel Costa de Andrade

Study Record Dates

First Submitted

December 3, 2015

First Posted

December 8, 2015

Study Start

September 1, 2015

Primary Completion

December 1, 2015

Study Completion

February 1, 2016

Last Updated

February 17, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will share

Locations

BR(1)