Diabetic Proliferative RetinopathyPhase 2/3NCT00417833
Multifocal Electrophysiologic Findings After Intravitreal Bevacizumab(Avastin)Treatment
A Phase 2/3 study testing Intravitreal Bevacizumab in people with Diabetic Proliferative Retinopathy and Vascular Vein Oclussion, run by Asociación para Evitar la Ceguera en México.
Trial summary
Purpose: Determine the short-term safety of intravitreal bevacizumab by multifocal electroretinography (mf-ERG). Methods: 120 eyes with choroidal neovascularization, proliferative diabetic retinopathy and retinal vein occlusion received intravitreal bevacizumab (2.5mg/0.1cc). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Proliferative Retinopathy, Vascular Vein Oclussion, Choroidal Neovascularization
- What is being tested?
- Intravitreal Bevacizumab
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Dec 2005to Jul 2006
- Phase
- Phase 2/3
- 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 Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Proliferative diabetic retinopathy, vascular vein oclussion, choroidal neovascularization
- Multifocal electroretinogram before intravitreal bevacizumab and at 1,3, and 6 months after treatment
- Completely studies
Who cannot join
- Complications
- Tractional Detachment
- Endophthalmitis
About this study
Purpose: Determine the short-term safety of intravitreal bevacizumab by multifocal electroretinography (mf-ERG).
Methods: 120 eyes with choroidal neovascularization, proliferative diabetic retinopathy and retinal vein occlusion received intravitreal bevacizumab (2.5mg/0.1cc). All patients underwent best corrected visual acuity, fluorescein angiography, optical coherent tomography and mf-ERG before and 1 month after treatment.
- Being tested
- Intravitreal Bevacizumab
- Medical subject headings
- Choroidal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal BevacizumabDrug
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 startDec 2005
- Study completionJul 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 Diabetic Proliferative RetinopathyStudies 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 2/3
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Asociación para Evitar la Ceguera en México
- Sponsor type
- University, hospital or other
- Investigators
- Myrian L Hernández, MD, Principal investigator, Asociación para Evitar la Ceguera en México
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00417833
- Sponsor's protocol ID
- APEC-0017
- Status last verified
- May 2024
- First submitted
- 3 Jan 2007
- 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
- Multifocal Electrophysiologic Findings After Intravitreal Bevacizumab(Avastin)Treatment
- ClinicalTrials.gov ID
- NCT00417833
- Acronym / sponsor ID
- APEC-0017
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accrual
- Lead sponsor
- Asociación para Evitar la Ceguera en MéxicoUniversity, hospital or other
- Study start
- Dec 2005
- Study completion
- Jul 2006
- 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.
Purpose: Determine the short-term safety of intravitreal bevacizumab by multifocal electroretinography (mf-ERG).
Methods: 120 eyes with choroidal neovascularization, proliferative diabetic retinopathy and retinal vein occlusion received intravitreal bevacizumab (2.5mg/0.1cc). All patients underwent best corrected visual acuity, fluorescein angiography, optical coherent tomography and mf-ERG before and 1 month after treatment.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Proliferative diabetic retinopathy, vascular vein oclussion, choroidal neovascularization
- Multifocal electroretinogram before intravitreal bevacizumab and at 1,3, and 6 months after treatment
- Completely studies
Key exclusion criteria (3 listed)
- Complications
- Tractional Detachment
- Endophthalmitis
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
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Poor accrual). Results are not available in the source record.
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.
Myrian L Hernández, MD principal investigator
Asociación para Evitar la Ceguera en México
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Intravitreal Bevacizumab in people with Diabetic Proliferative Retinopathy and Vascular Vein Oclussion, run by Asociación para Evitar la Ceguera en México.
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 3 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: stopped early, 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.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: Poor accrual). 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.
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.