The Efficacy of Subconjunctival Bevacizumab in Diabetic M... | NCT02796183

Studies
The Efficacy of Subconjunctival Bevacizumab in Diabetic Macular Edema

NCT02796183

Sponsor

Neon Hospital

Status

Completed

Last Update Posted

Jun 10, 2016Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Diabetic Macular Edema

Interventions

Subconjunctival bevacizumab (Altuzan)

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

Jun 2016

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

Jan 2015

Primary Completion Date

Apr 2016Actual

Completion Date

May 2016Actual

First Submitted Date

Jun 7, 2016

First Submission Date that Met QC Criteria

Jun 9, 2016

First Posted Date

Jun 10, 2016Estimated

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

Jun 9, 2016

Last Update Posted Date

Jun 10, 2016Estimated

Name	Class
Ondokuz Mayıs University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

This study evaluates the effects of subconjunctivally injected bevacizumab in patients with diffuse diabetic macular edema.

Detailed Description

At baseline, the macular thicknesses of both eyes of the patients with persistant diabetic macular edema were measured by optical coherence tomography. After 3.75mg bevacizumab was injected into subconjunctival space of the eyes with diabetic macular edema. The measurements of the macular thicknesses were repeated by optical coherence tomography in 15th, 30th, 60th day after injections. The macular thickness measurements before and after injection were compared.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diabetic macular edema	Other	Bevacizumab (Altuzan) was injected subconjunctival space of the patients.	Drug: Subconjunctival bevacizumab (Altuzan)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Subconjunctival bevacizumab (Altuzan)	Drug	Subconjunctival injections of Altuzan 3.75mg were applied in order to eliminate the macular edema.	Diabetic macular edema

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Central Macular Thickness		one year (between May 2015 and May 2016)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Having diffuse diabetic macular edema persisted at least 1 month
No intravitreal injection in last 3 months.
No retinal laser photocoagulation in last 6 months
Not have any other macular disease causing macular edema

Exclusion Criteria:

Having ischemic macula
Intravitreal injection in last 3 months.
Retinal laser photocoagulation in last 6 months
Have any other macular disease causing macular edema

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided