Diffuse Diabetic Macular EdemaPhase 4NCT00567372
POSTERIOR SUB-TENON'S Avastin
A Phase 4 study testing bevacizumab (Sub-tenon´s injection) in people with Diffuse Diabetic Macular Edema, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
Trial summary
Posterior sub-tenon's injection of bevacizumab decreased diffuse diabetic macular edema Read more about this study
- Who is it for?
- Ages 25 to 90 years
- Conditions the study is for
- Diffuse Diabetic Macular Edema
- What is being tested?
- bevacizumab (Sub-tenon´s injection)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- Jun 2008to Jun 2009
- Phase
- Phase 4
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with diffuse diabetic macular edema non-proliferative diabetic retinopathy Maculat thickness ≥250 μ BCVA ≥ 20/400 Without any treatment
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Asociación para Evitar la Ceguera en Mexico
Mexico City, Mexico City, 04030
About this study
Official title: POSTERIOR SUB-TENON'S CAPSULE INJECTION OF BEVACIZUMAB FOR TREATMENT OF DIFFUSE DIABETIC MACULAR EDEMA
Posterior sub-tenon's injection of bevacizumab decreased diffuse diabetic macular edema
- Conditions
- Diffuse Diabetic Macular Edema
- Being tested
- bevacizumab (Sub-tenon´s injection)
- Keywords
- Diffuse diabetic macular edema, sub-tenon, Bevacizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumab (Sub-tenon´s injection)Drug
a single posterior sub-tenon's capsule injection of bevacizumab (2.5 mg /0.1ml)
What is being measured
The primary outcome is the main question the study is designed to answer.
macular volume
Measured: baseline, 3,6 and 12 weeks
Secondary outcomes (2)
macular thickness
Measured: baseline,3,6 and 12 weeks
best corrected visual acuity
Measured: baseline, 3,6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2007 (estimated)
- Study startJun 2008
- Primary completionNov 2008
- Study completionJun 2009
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 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- 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
- Sandra Vera, MD, Principal investigator, Asociación para Evitar la Ceguera en MexicoHugo Quiroz-Mercado, MD, Principal investigator, Denver Health Medical CenterAdai Pérez-Montesinos, MD, Principal investigator, Asociación para Evitar la Ceguera en Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567372
- Sponsor's protocol ID
- 00922
- Status last verified
- May 2024
- First submitted
- 30 Nov 2007
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- 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
- POSTERIOR SUB-TENON'S CAPSULE INJECTION OF BEVACIZUMAB FOR TREATMENT OF DIFFUSE DIABETIC MACULAR EDEMA
- ClinicalTrials.gov ID
- NCT00567372
- Acronym / sponsor ID
- 00922
- Conditions
- Diffuse Diabetic Macular Edema
- Keywords
- Diffuse diabetic macular edema, sub-tenon, Bevacizumab
- Phase
- Phase 4
- 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
- Jun 2008 (actual)
- Primary completion
- Nov 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 4 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.
Posterior sub-tenon's injection of bevacizumab decreased diffuse diabetic macular edema
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 25 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with diffuse diabetic macular edema non-proliferative diabetic retinopathy Maculat thickness ≥250 μ BCVA ≥ 20/400 Without any treatment
Key exclusion criteria (0 listed)
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 (Sub-tenon´s injection)a single posterior sub-tenon's capsule injection of bevacizumab (2.5 mg /0.1ml) | Drug | – |
Primary outcome
macular volume
Time frame: baseline, 3,6 and 12 weeks
2 secondary outcomes
macular thickness
Time frame: baseline,3,6 and 12 weeks
best corrected visual acuity
Time frame: baseline, 3,6 and 12 weeks
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.
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.
Sandra Vera, MD principal investigator
Asociación para Evitar la Ceguera en Mexico
Hugo Quiroz-Mercado, MD principal investigator
Denver Health Medical Center
Adai Pérez-Montesinos, MD principal investigator
Asociación para Evitar la Ceguera en Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing bevacizumab (Sub-tenon´s injection) 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 1 inclusion and 0 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
macular volume (time frame: baseline, 3,6 and 12 weeks). 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.