Diffuse Diabetic Macular EdemaPhase 3NCT00600301
Vitrectomy Without Internal Limiting Membrane Removal in the Treatment of Diffuse Diabetic Macular Edema: a Comparative Kenalog Vs Bevacizumab Intravitreal Injection Vs Control Study
A Phase 3 study testing Triamcinolone Acetonide and Bevacizumab in people with Diffuse Diabetic Macular Edema, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
Trial summary
Diabetic macular edema is the most common cause of visual loss among patients with diabetic retinopathy. Pars plana vitrectomy has been reported to be effective for the treatment of diabetic macular edema. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Diffuse Diabetic Macular Edema
- What is being tested?
- Triamcinolone Acetonide and Bevacizumab
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2008to Jan 2008
- Phase
- Phase 3
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diffuse diabetic macular edema
- Non proliferative diabetic retinopathy
- No VPP previa
- No previous treament with laser, Triamcinolone acetonide, and Bevacizumab
Who cannot join
- Proliferative diabetic retinopathy
- Previous pars plana vitrectomy
- Previous treatment with diabetic macular edema
- Focal macular edema
- Macular Ischemia
Trial locations and contacts
1 site in 1 country.
About this study
Diabetic macular edema is the most common cause of visual loss among patients with diabetic retinopathy. Pars plana vitrectomy has been reported to be effective for the treatment of diabetic macular edema. Previous report showed a limited improvement in visual acuity and macular thickness posterior intraoperative triamcinolone acetonide. Bevacizumab intravitreal injection has been proven be effective in the treatment of diabetic macular edema, in recent publications. The purpose of this study is to evaluate whether vitrectomy with and without intravitreal triamcinolone acetonide and bevacizumab injection affects vision outcome and macular thickness in patients with diabetic macular edema.
- Conditions
- Diffuse Diabetic Macular Edema
- Being tested
- Triamcinolone Acetonide and Bevacizumab
- Keywords
- Macula, Edema
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone Acetonide and BevacizumabDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2008
- Study completionJan 2008
Why it stopped: undefined
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asociación para Evitar la Ceguera en México
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maximiliano Gordon, MD, Principal investigator, Asociación para Evitar la Ceguera en México
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00600301
- Sponsor's protocol ID
- APEC-OO13
- Status last verified
- May 2024
- First submitted
- 30 Jun 2006
- Last updated
- 30 May 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitrectomy Without Internal Limiting Membrane Removal in the Treatment of Diffuse Diabetic Macular Edema: a Comparative Kenalog Vs Bevacizumab Intravitreal Injection Vs Control Study
- ClinicalTrials.gov ID
- NCT00600301
- Acronym / sponsor ID
- APEC-OO13
- Conditions
- Diffuse Diabetic Macular Edema
- Keywords
- Macula, Edema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: undefined
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Asociación para Evitar la Ceguera en MéxicoUniversity, hospital or other
- Study start
- Jan 2008 (actual)
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 24 Jan 2008 (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.
Diabetic macular edema is the most common cause of visual loss among patients with diabetic retinopathy. Pars plana vitrectomy has been reported to be effective for the treatment of diabetic macular edema. Previous report showed a limited improvement in visual acuity and macular thickness posterior intraoperative triamcinolone acetonide. Bevacizumab intravitreal injection has been proven be effective in the treatment of diabetic macular edema, in recent publications. The purpose of this study is to evaluate whether vitrectomy with and without intravitreal triamcinolone acetonide and bevacizumab injection affects vision outcome and macular thickness in patients with diabetic macular edema.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diffuse diabetic macular edema
- Non proliferative diabetic retinopathy
- No VPP previa
- No previous treament with laser, Triamcinolone acetonide, and Bevacizumab
Key exclusion criteria (5 listed)
- Proliferative diabetic retinopathy
- Previous pars plana vitrectomy
- Previous treatment with diabetic macular edema
- Focal macular edema
- Macular Ischemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triamcinolone Acetonide and Bevacizumab | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
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.
Maximiliano Gordon, MD principal investigator
Asociación para Evitar la Ceguera en México
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Triamcinolone Acetonide and Bevacizumab in people with Diffuse Diabetic Macular Edema, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 30 May 2024. 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 Mexico. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 30 May 2024.