Diabetes Mellitus Type 2Phase 3NCT00417716
Use of Intravitreal Bevacizumab in Patients With Diffuse Diabetic Macular Edema
A Phase 3 study testing Intravitreal Bevacizumab in people with Diabetes Mellitus Type 2 and Diabetic Macular Edema, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
Trial summary
Intravitreal Bevacizumab is an effective treatment for the diffuse diabetic macular edema Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Diabetes Mellitus Type 2, Diabetic Macular Edema
- What is being tested?
- Intravitreal Bevacizumab
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- Sep 2005to May 2006
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- Macular edema involving the center of the macula demonstrated on OCT
- Clear ocular media
- Untreated patients
- Older than 45 years
- BCVA of the fellow eye at least 20/100
Who cannot join
- Renal diabetic disease, uncontrolled hypertension or stroke history
- Other ocular disease
- Ocular surgery excepting uncomplicated phacoemulsification
- History of photocoagulation (panretinal or focal)
- History of another intravitreal treatment (like triamcinolone)
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Asociación para Evitar la Ceguera en México
Mexico City, Mexico City, 04030
About this study
Official title: The Efficacy of a Single Intravitreal Injection of Bevacizumab in Patients With Diffuse Diabetic Macular Edema
Intravitreal Bevacizumab is an effective treatment for the diffuse diabetic macular edema
Read the detailed description
A non-randomized prospective clinical interventional study which includes 45 non previously treated patients with DME. The patients received a single intravitreal injection of 2.5 mg bevacizumab. Follow-up included clinical examination (best corrected visual acuity (BCVA, intraocular pressure (IOP), cataract grading, DME characteristics and systemic check-up) pre-injection, at first visit, at weeks 1 and 2 and months 1 and 3. OCT and fluorescein angiography was evaluated at months 1 and 3.
- Conditions
- Diabetes Mellitus Type 2, Diabetic Macular Edema
- Being tested
- Intravitreal Bevacizumab
- Keywords
- Diffuse Diabetic Macular Edema, Intravitreal Bevacizumab, Anti-VEGF drugs
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal BevacizumabDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
BCVA
Fluorescein Angiography
Optical Coherence Tomography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2007 (estimated)
- Study startSep 2005
- Primary completionSep 2005
- Study completionMay 2006
Why it stopped: Poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies 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
- Investigators
- Adriana Solís-Vivanco, MD, Principal investigator, Asociación para Evitar la Ceguera en MéxicoJans Fromow-Guerra, MD PhD, Study chair, Asociación para Evitar la Ceguera en MéxicoElizabeth Reyna-Castelán, Study chair, Asociación para Evitar la Ceguera en MéxicoJuan M Jiménez-Sierra, MD, Study chair, Asociación para Evitar la Ceguera en MéxicoMyriam Hernández-Rojas, MD, Study chair, Asociación para Evitar la Ceguera en MéxicoGriselda Alvarez-Rivera, MD, Study chair, Asociación para Evitar la Ceguera en MéxicoHugo Quiroz-Mercado, MD, Study director, Asociación para Evitar la Ceguera en México
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00417716
- Sponsor's protocol ID
- APEC-0011
- Status last verified
- May 2024
- First submitted
- 30 Jun 2006
- Last updated
- 3 Jun 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of a Single Intravitreal Injection of Bevacizumab in Patients With Diffuse Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT00417716
- Acronym / sponsor ID
- APEC-0011
- Conditions
- Diabetes Mellitus Type 2, Diabetic Macular Edema
- Keywords
- Diffuse Diabetic Macular Edema, Intravitreal Bevacizumab, Anti-VEGF drugs
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Poor accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Asociación para Evitar la Ceguera en MéxicoUniversity, hospital or other
- Study start
- Sep 2005 (actual)
- Primary completion
- Sep 2005 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 4 Jan 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.
Intravitreal Bevacizumab is an effective treatment for the diffuse diabetic macular edema
Detailed description
A non-randomized prospective clinical interventional study which includes 45 non previously treated patients with DME. The patients received a single intravitreal injection of 2.5 mg bevacizumab. Follow-up included clinical examination (best corrected visual acuity (BCVA, intraocular pressure (IOP), cataract grading, DME characteristics and systemic check-up) pre-injection, at first visit, at weeks 1 and 2 and months 1 and 3. OCT and fluorescein angiography was evaluated at months 1 and 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Type 2 diabetes
- Macular edema involving the center of the macula demonstrated on OCT
- Clear ocular media
- Untreated patients
- Older than 45 years
Key exclusion criteria (5 listed)
- Renal diabetic disease, uncontrolled hypertension or stroke history
- Other ocular disease
- Ocular surgery excepting uncomplicated phacoemulsification
- History of photocoagulation (panretinal or focal)
- History of another intravitreal treatment (like triamcinolone)
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 |
|---|---|---|
| Intravitreal Bevacizumab | Drug | – |
Primary outcome
BCVA
Fluorescein Angiography
Optical Coherence Tomography
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 3 Jun 2024.
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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.
Adriana Solís-Vivanco, MD principal investigator
Asociación para Evitar la Ceguera en México
Jans Fromow-Guerra, MD PhD study chair
Asociación para Evitar la Ceguera en México
Elizabeth Reyna-Castelán study chair
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 Intravitreal Bevacizumab in people with Diabetes Mellitus Type 2 and 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 6 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 3 Jun 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.
What does the primary outcome measure?
BCVA. The study lists 3 primary outcomes in all. 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 3 Jun 2024.