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

Diabetic Macular Edema Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01769599
• Other study ID #: 0108-12-ZIV
• Status: Recruiting
• Phase: N/A
• First received: January 14, 2013
• Last updated: January 14, 2013
• Start date: January 2013
• Est. completion date: April 2014

Study information

• Verified date: January 2013
• Source: Ziv Hospital
• Contact: Joseph Pikkel, M.D
• Phone: +972-50-4348206
• Email: pikel.y[@]ziv.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Diabetus Mellitus
• Macular Edema

Locations

Country	Name	City	State
Israel	Ziv Medical Center	Safed

Sponsors (1)

Lead Sponsor	Collaborator
Ziv Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Macular thickness	by measuring the retinal thickness and comparing in both aproaches. and see if there is any difference.	36 months	No