Vogt Koyanagi Harada DiseasePhase 3NCT00407121
Intravitreal Bevacizumab for Inflammatory Neovascular Membranes
A Phase 3 study testing Bevacizumab and Intravitreal Injection of Bevacizumab in people with Vogt Koyanagi Harada Disease and Serpiginous Choroiditis, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
Trial summary
Intravitreal injection of Bevacizumab in patients with Neovascular Membranes secondary to intraocular inflammation. We injected a single injection of Bevacizumab (2.5 mg/0.1 ml) and evaluate visual acuity , Fluorescein angiogram and retinal thickness by Optical Coherence Tomography (OCT) in 4 patients with Vogt… Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Vogt Koyanagi Harada Disease, Serpiginous Choroiditis, Multifocal Choroiditis
- What is being tested?
- Bevacizumab and Intravitreal Injection of Bevacizumab
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- Dec 2006to Dec 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical Diagnose
- Patient Consent
- Chronic stage of inflammation
Who cannot join
- only eye
- age lower than 30 yo.
- Systemic condition
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: Intravitreal Bevacizumab for the Treatment of Neovascular Membranes in Patients With Intraocular Inflammation
Intravitreal injection of Bevacizumab in patients with Neovascular Membranes secondary to intraocular inflammation. We injected a single injection of Bevacizumab (2.5 mg/0.1 ml) and evaluate visual acuity , Fluorescein angiogram and retinal thickness by Optical Coherence Tomography (OCT) in 4 patients with Vogt Koyanagi Harada disease, 1 patient with Serpiginous Choroidopathy and 1 patient with Multifocal Choroiditis.
- Being tested
- Bevacizumab, Intravitreal Injection of Bevacizumab
- Keywords
- Neovascular Membrane, Uveitis, Bevacizumab
- Medical subject headings
- Uveomeningoencephalitic Syndrome, White Dot Syndromes, Multifocal Choroiditis, Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Intravitreal Injection of BevacizumabProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity
Retinal thickness by OCT
Leakage in 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 startDec 2006
- Primary completionDec 2006
- Study completionDec 2006
Why it stopped: Undefined.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vogt Koyanagi Harada DiseaseStudies 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
- Responsible party
- Sponsor
- Investigators
- Veronica Kon-Jara, MD, Principal investigator, Asociación para Evitar la Ceguera en MéxicoLuzElena Concha-Del Rio, MD, Study chair, Asociación para Evitar la Ceguera en México
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00407121
- Sponsor's protocol ID
- APEC-0025
- Status last verified
- May 2024
- First submitted
- 1 Dec 2006
- Last updated
- 30 May 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Bevacizumab for the Treatment of Neovascular Membranes in Patients With Intraocular Inflammation
- ClinicalTrials.gov ID
- NCT00407121
- Acronym / sponsor ID
- APEC-0025
- Keywords
- Neovascular Membrane, Uveitis, Bevacizumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Undefined.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Asociación para Evitar la Ceguera en MéxicoUniversity, hospital or other
- Study start
- Dec 2006 (actual)
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 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.
Intravitreal injection of Bevacizumab in patients with Neovascular Membranes secondary to intraocular inflammation. We injected a single injection of Bevacizumab (2.5 mg/0.1 ml) and evaluate visual acuity , Fluorescein angiogram and retinal thickness by Optical Coherence Tomography (OCT) in 4 patients with Vogt Koyanagi Harada disease, 1 patient with Serpiginous Choroidopathy and 1 patient with Multifocal Choroiditis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Clinical Diagnose
- Patient Consent
- Chronic stage of inflammation
Key exclusion criteria (3 listed)
- only eye
- age lower than 30 yo.
- Systemic condition
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 | Drug | – |
| Intravitreal Injection of Bevacizumab | Procedure or surgery | – |
Primary outcome
Best corrected visual acuity
Retinal thickness by OCT
Leakage in Fluorescein angiogram
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 30 May 2024.
Related trials for Vogt Koyanagi Harada Disease
Recruiting
Early Immunosuppressive Therapy on the Course of Vogt-Koyanagi-Harada Disease
Vogt Koyanagi Harada Disease
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
LuzElena Concha-Del Rio, MD 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 Bevacizumab and Intravitreal Injection of Bevacizumab in people with Vogt Koyanagi Harada Disease and Serpiginous Choroiditis, 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: withdrawn, as of the sponsor's last update on 30 May 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?
Best corrected visual acuity. 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 30 May 2024.