Comparison of Initial Treatment in With Laser Grid in Dia... | NCT01769599

Studies
Comparison of Initial Treatment in With Laser Grid in Diabetic Macular Edema to Intra Vitreal Avastin Injections

NCT01769599

Sponsor

Ziv Hospital

Status

Unknown status

Last Update Posted

Jan 16, 2013Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Diabetic Macular Edema
Diabetus Mellitus

Interventions

Not provided

Countries

Israel

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

Jan 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Jan 2014Estimated

Completion Date

Apr 2014Estimated

First Submitted Date

Jan 14, 2013

First Submission Date that Met QC Criteria

Jan 14, 2013

First Posted Date

Jan 16, 2013Estimated

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

Jan 14, 2013

Last Update Posted Date

Jan 16, 2013Estimated

Description Module

Brief Summary

there is no yet agreement about the best way to treat Diabetic Macular Edema (DME) the two options up to day are using Grid laser treatment Vs. Avastin injections or a combination of both in this study we want to compare the two attitudes.

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

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Grid Treatment		30 patients that were treated with laser grid treatment
Avastin Treatment		patients that were treated with Avastin injections

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Macular thickness	by measuring the retinal thickness and comparing in both aproaches. and see if there is any difference.	36 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diabetic patients with macular edema
age 30 to 80 Yrs. old
no previous ocular treatment
patiens with macular edema that was shown by OCT or FA
patients with at least 6 months follow-up after the last treatment

Exclusion Criteria:

patients with other ocular disease (such as glaucoma etc.)
patients with previous ocular surgery
patiens with eye trauma
patiens with macular edema not from DM

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Diabetic people that suffer from macular edema

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Joseph Pikkel, M.D	Contact	+972-50-4348206		pikel.y@ziv.health.gov.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ziv Medical Center	Recruiting	Safed		13100	Israel