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

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ClinicalTrials.gov Identifier: NCT01769599
Recruitment Status : Unknown
Verified January 2013 by yehudit.hackmon, Ziv Hospital.
Recruitment status was:  Recruiting
First Posted : January 16, 2013
Last Update Posted : January 16, 2013
Information provided by (Responsible Party):
yehudit.hackmon, Ziv Hospital

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.

Condition or disease
Diabetic Macular Edema Diabetus Mellitus

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Retrospective
Study Start Date : January 2013
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Macular thickness [ Time Frame: 36 months ]
    by measuring the retinal thickness and comparing in both aproaches. and see if there is any difference.

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diabetic people that suffer from macular edema

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01769599

Contact: Joseph Pikkel, M.D +972-50-4348206 pikel.y@ziv.health.gov.il

Ziv Medical Center Recruiting
Safed, Israel, 13100
Contact: Otzem Chassid, M.D         
Principal Investigator: Joseph Pikkel, M.D         
Sponsors and Collaborators
Ziv Hospital

Responsible Party: yehudit.hackmon, Reaserch coordinator, Ziv Hospital
ClinicalTrials.gov Identifier: NCT01769599     History of Changes
Other Study ID Numbers: 0108-12-ZIV
First Posted: January 16, 2013    Key Record Dates
Last Update Posted: January 16, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents