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

January 14, 2013 updated by: yehudit.hackmon, Ziv Hospital
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Safed, Israel, 13100
        • Recruiting
        • Ziv Medical Center
        • Contact:
          • Otzem Chassid, M.D
        • Principal Investigator:
          • Joseph Pikkel, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Diabetic people that suffer from macular edema

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Grid Treatment
30 patients that were treated with laser grid treatment
Avastin Treatment
patients that were treated with Avastin injections

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ziv Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

January 1, 2014

Study Completion (Anticipated)

April 1, 2014

Study Registration Dates

First Submitted

January 14, 2013

First Submitted That Met QC Criteria

January 14, 2013

First Posted (Estimate)

January 16, 2013

Study Record Updates

Last Update Posted (Estimate)

January 16, 2013

Last Update Submitted That Met QC Criteria

January 14, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0108-12-ZIV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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