Edema MacularPhase 3NCT00347711
Bevacizumab and Retinal Vascular Occlusions
A Phase 3 study testing Intravitreal injection in people with Edema Macular and Vascular Occlusion, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
Trial summary
To evaluate the effects of Intravitreal Bevacizumab in macular edema in retinal vascular occlusion. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Edema Macular, Vascular Occlusion
- What is being tested?
- Intravitreal injection
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- Jun 2006to Jun 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 40 to 90 years
- All sexes
- Adult, Older adult
Who may be able to join
- Vascular occlusion and edema macular diagnosticated by fluorescein angiography and coherent optic tomography
Who cannot join
- Previous surgery
- Uveitis
- Glaucoma
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Asociacion para Evitar la Ceguera en Mexico
México, D.F. Mexico, 04030
About this study
To evaluate the effects of Intravitreal Bevacizumab in macular edema in retinal vascular occlusion.
- Conditions
- Edema Macular, Vascular Occlusion
- Being tested
- Intravitreal injection
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal injectionDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startJun 2006
- Primary completionJun 2006
- Study completionJun 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 Edema MacularStudies 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
- 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
- Griselda Alvarez, Fellow, Principal investigator, Asociación para Evitar la Ceguera en México
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00347711
- Sponsor's protocol ID
- APEC-0020
- 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
- Bevacizumab and Retinal Vascular Occlusions
- ClinicalTrials.gov ID
- NCT00347711
- Acronym / sponsor ID
- APEC-0020
- Conditions
- Edema Macular, Vascular Occlusion
- 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
- Jun 2006 (actual)
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 4 Jul 2006 (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 the effects of Intravitreal Bevacizumab in macular edema in retinal vascular occlusion.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Vascular occlusion and edema macular diagnosticated by fluorescein angiography and coherent optic tomography
Key exclusion criteria (3 listed)
- Previous surgery
- Uveitis
- Glaucoma
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 injection | 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 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.
Griselda Alvarez, Fellow 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 Intravitreal injection in people with Edema Macular and Vascular Occlusion, 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 3 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.
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.