Diffuse Diabetic Macular EdemaPhase 3NCT00571142
Vitrectomy and Bevacizumab for Diffuse Diabetic Macular Edema
A Phase 3 study testing Bevacizumab + Pars plana vitrectomy in people with Diffuse Diabetic Macular Edema, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
Trial summary
To Evaluate combined effect of vitrectomy and bevacizumab to stabilize retinal thickness and visual acuity in patients with diffuse diabetic macular edema and their relation to renal disease. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Diffuse Diabetic Macular Edema
- What is being tested?
- Bevacizumab + Pars plana vitrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteMexico
- Study dates
- Nov 2007to Feb 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Older than 25 yo
- Diffuse diabetic macular edema with or without previous treatment
Who cannot join
- Another retinal disease
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pars Plana Vitrectomy and Bevacizumab for the Treatment of Diffuse Diabetic Macular Edema (A Pilot Study)
To Evaluate combined effect of vitrectomy and bevacizumab to stabilize retinal thickness and visual acuity in patients with diffuse diabetic macular edema and their relation to renal disease.
- Conditions
- Diffuse Diabetic Macular Edema
- Being tested
- Bevacizumab + Pars plana vitrectomy
- Keywords
- edema, retinal thickness, diabetic retinopathy
- Medical subject headings
- Edema, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab + Pars plana vitrectomyProcedure or surgery
2.5 mg / 0.1 ml bevacizumab after pars plana vitrectomy. Limitorexis would be optional.
Bevacizumab + pars plana vitrectomyProcedure or surgery
2.5 mg /0.1 ml of bevacizumab after pars plana vitrectomy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Renal disease Receives: Procedure: Bevacizumab + Pars plana vitrectomy |
| 2 | Active comparator | Without renal disease Receives: Procedure: Bevacizumab + pars plana vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal thickness
Measured: 3 months
Secondary outcomes (1)
Visual acuity
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2007 (estimated)
- Study startNov 2007
- Primary completionNov 2007
- Study completionFeb 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asociación para Evitar la Ceguera en México
- Sponsor type
- University, hospital or other
- Investigators
- Veronica Kon-Jara, MD, Principal investigator, Asociación para Evitar la Ceguera en México
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00571142
- Sponsor's protocol ID
- APEC-ret
- Status last verified
- May 2024
- First submitted
- 7 Dec 2007
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pars Plana Vitrectomy and Bevacizumab for the Treatment of Diffuse Diabetic Macular Edema (A Pilot Study)
- ClinicalTrials.gov ID
- NCT00571142
- Acronym / sponsor ID
- APEC-ret
- Conditions
- Diffuse Diabetic Macular Edema
- Keywords
- edema, retinal thickness, diabetic retinopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: undefined
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Asociación para Evitar la Ceguera en MéxicoUniversity, hospital or other
- Study start
- Nov 2007 (actual)
- Primary completion
- Nov 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 11 Dec 2007 (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.
To Evaluate combined effect of vitrectomy and bevacizumab to stabilize retinal thickness and visual acuity in patients with diffuse diabetic macular edema and their relation to renal disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Bevacizumab + Pars plana vitrectomyRenal disease |
| 2 | Active comparator | Procedure: Bevacizumab + pars plana vitrectomyWithout renal disease |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Older than 25 yo
- Diffuse diabetic macular edema with or without previous treatment
Key exclusion criteria (2 listed)
- Another retinal disease
- Pregnancy
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 |
|---|---|---|
| Bevacizumab + Pars plana vitrectomy2.5 mg / 0.1 ml bevacizumab after pars plana vitrectomy. Limitorexis would be optional. | Procedure or surgery | 1 |
| Bevacizumab + pars plana vitrectomy2.5 mg /0.1 ml of bevacizumab after pars plana vitrectomy | Procedure or surgery | 2 |
Primary outcome
Retinal thickness
Time frame: 3 months
1 secondary outcome
Visual acuity
Time frame: 3 months
Results and safety
The study was stopped early (reason given: undefined). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 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.
Veronica Kon-Jara, 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 Bevacizumab + Pars plana vitrectomy 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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 31 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 stopped early (reason given: undefined). Results are not available in the source record.
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.
What does the primary outcome measure?
Retinal thickness (time frame: 3 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 31 May 2024.