Diabetic Macular EdemaNCT01769599
Comparison of Initial Treatment in With Laser Grid in Diabetic Macular Edema to Intra Vitreal Avastin Injections
An observational study of Diabetic Macular Edema and Diabetus Mellitus, run by Ziv Hospital at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Diabetic Macular Edema, Diabetus Mellitus
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2013to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diabetic people that suffer from macular edema
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Ziv Medical Center
Safed, 13100
Otzem Chassid, M.D
Joseph Pikkel, M.D
About this study
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.
- Conditions
- Diabetic Macular Edema, Diabetus Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Grid Treatment | 30 patients that were treated with laser grid treatment | |
| Avastin Treatment | patients that were treated with Avastin injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular thickness
by measuring the retinal thickness and comparing in both aproaches. and see if there is any difference.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2014 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, yehudit.hackmon, Ziv Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01769599
- Sponsor's protocol ID
- 0108-12-ZIV
- Status last verified
- Jan 2013
- First submitted
- 14 Jan 2013
- Last updated
- 16 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Initial Treatment in With Laser Grid in Diabetic Macular Edema to Intra Vitreal Avastin Injections
- ClinicalTrials.gov ID
- NCT01769599
- Acronym / sponsor ID
- 0108-12-ZIV
- Conditions
- Diabetic Macular Edema, Diabetus Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ziv HospitalOther government
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 16 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grid Treatment | – | –30 patients that were treated with laser grid treatment |
| Avastin Treatment | – | –patients that were treated with Avastin injections |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic people that suffer from macular edema
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Macular thickness
Time frame: 36 months
by measuring the retinal thickness and comparing in both aproaches. and see if there is any difference.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Macular Edema and Diabetus Mellitus, run by Ziv Hospital at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joseph Pikkel, M.D (+972-50-4348206, pikel.y@ziv.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Macular thickness (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2013.