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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by yehudit.hackmon, Ziv Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01769599
First Posted: January 16, 2013
Last Update Posted: January 16, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
yehudit.hackmon, Ziv Hospital
  Purpose
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
Diabetic Macular Edema Diabetus Mellitus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by yehudit.hackmon, Ziv Hospital:

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


Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Grid Treatment
30 patients that were treated with laser grid treatment
Avastin Treatment
patients that were treated with Avastin injections

  Eligibility

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
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
  Contacts and Locations
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


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

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

Responsible Party: yehudit.hackmon, Reaserch coordinator, Ziv Hospital
ClinicalTrials.gov Identifier: NCT01769599     History of Changes
Other Study ID Numbers: 0108-12-ZIV
First Submitted: January 14, 2013
First Posted: January 16, 2013
Last Update Posted: January 16, 2013
Last Verified: January 2013

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