NCT01769599

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 16, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

1 year

First QC Date

January 14, 2013

Last Update Submit

January 14, 2013

Conditions

Diabetic Macular EdemaDiabetus Mellitus

Outcome Measures

Primary Outcomes (1)

  • Macular thickness

    by measuring the retinal thickness and comparing in both aproaches. and see if there is any difference.

    36 months

Study Arms (2)

Grid Treatment

30 patients that were treated with laser grid treatment

Avastin Treatment

patients that were treated with Avastin injections

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Diabetic people that suffer from macular edema

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziv Medical Center

Safed, 13100, Israel

RECRUITING

Central Study Contacts

Joseph Pikkel, M.D

CONTACT

+972-50-4348206pikel.y@ziv.health.gov.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Reaserch coordinator

Study Record Dates

First Submitted

January 14, 2013

First Posted

January 16, 2013

Study Start

January 1, 2013

Primary Completion

January 1, 2014

Study Completion

April 1, 2014

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations

IL(1)