Age Related Macular DegenerationPhase 3NCT00406744
Efficacy of Retreatments With Intravitreal Bevacizumab
A Phase 3 study testing Intravitreal injection of Bevacizumab in people with Age Related Macular Degeneration and Choroidal Neovascularization, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
Trial summary
Choroidal neovascularization is a leading cause of visual loss in people older than 60 years and for its treatment there had been performed multicentric studies with Lucentis (Ranibizumab) with a significant improval of visual acuity. Read more about this study
- Who is it for?
- Ages 60 to 95 years
- Conditions the study is for
- Age Related Macular Degeneration, Choroidal Neovascularization
- What is being tested?
- Intravitreal injection of Bevacizumab
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteMexico
- Study dates
- May 2006to Nov 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 60 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- * Any visual acuity
- OCT: Central foveal thickness greater than 300 u or with evidence of subretinal fluid.
- Active angiogram leakage
Who cannot join
- * Basal Inflammatory disease
- Endoftalmitis history
- Lesions bigger than 5400 u or with scarring greater than 50% of lesion.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Asociacion para Evitar la Ceguera en Mexico
Mexico City, Mexico City, 04030
About this study
Official title: Evaluation of Efficacy of Intravitreal Bevacizumab Retreatments
Choroidal neovascularization is a leading cause of visual loss in people older than 60 years and for its treatment there had been performed multicentric studies with Lucentis (Ranibizumab) with a significant improval of visual acuity. In our institution we evaluated efficacy of bevacizumab in several pathologies but we dont know what would be the results if we use the same dose several times. Our purpose was to determine the efficacy of bevacizumab for improve or stabilize visual acuity with two or more intravitreal inyections of bevacizumab.
- Being tested
- Intravitreal injection of Bevacizumab
- Keywords
- neovascularization
- Medical subject headings
- Macular Degeneration, Choroidal Neovascularization, Neovascularization, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal injection of BevacizumabDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity, OCT foveal thickness and fluorescein angiogram
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2006 (estimated)
- Study startMay 2006
- Primary completionMay 2006
- Study completionNov 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 Age Related Macular DegenerationStudies 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
- NCT00406744
- Sponsor's protocol ID
- APEC-0012
- Status last verified
- May 2024
- First submitted
- 30 Nov 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
- Evaluation of Efficacy of Intravitreal Bevacizumab Retreatments
- ClinicalTrials.gov ID
- NCT00406744
- Acronym / sponsor ID
- APEC-0012
- Keywords
- neovascularization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accrual
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Asociación para Evitar la Ceguera en MéxicoUniversity, hospital or other
- Study start
- May 2006 (actual)
- Primary completion
- May 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 4 Dec 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.
Choroidal neovascularization is a leading cause of visual loss in people older than 60 years and for its treatment there had been performed multicentric studies with Lucentis (Ranibizumab) with a significant improval of visual acuity. In our institution we evaluated efficacy of bevacizumab in several pathologies but we dont know what would be the results if we use the same dose several times. Our purpose was to determine the efficacy of bevacizumab for improve or stabilize visual acuity with two or more intravitreal inyections of bevacizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- * Any visual acuity
Key exclusion criteria (3 listed)
- * Basal Inflammatory disease
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 of Bevacizumab | Drug | – |
Primary outcome
Best corrected visual acuity, OCT foveal thickness and fluorescein angiogram
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.
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 Intravitreal injection of Bevacizumab in people with Age Related Macular Degeneration and Choroidal Neovascularization, 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 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.
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: 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.
What does the primary outcome measure?
Best corrected visual acuity, OCT foveal thickness and fluorescein angiogram. 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.