Central Serous ChorioretinopathyPhase 2/3NCT00418431
Intravitreal Bevacizumab for the Treatment of Central Serous Chorioretinopathy
A Phase 2/3 study testing Intravitreal injection of Bevacizumab in people with Central Serous Chorioretinopathy, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
Trial summary
Central serous chorioretinopathy (CSC) has been known since it was first described by Von Graefe and termed "idiopathic detachment of the macula" in 1866, is a well-characterized disorder leading to serous neurosensory elevation of the central macula. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Central Serous Chorioretinopathy
- What is being tested?
- Intravitreal injection of Bevacizumab
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- Apr 2006to Aug 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 20 to 50 years
- All sexes
- Adult
Who may be able to join
- Any visual acuity.
- Central serous chorioretinopathy
Who cannot join
None listed.
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
Central serous chorioretinopathy (CSC) has been known since it was first described by Von Graefe and termed "idiopathic detachment of the macula" in 1866, is a well-characterized disorder leading to serous neurosensory elevation of the central macula. The acute form of the disease is associated with focal leakage at the level of the retinal pigment epithelium (RPE) demonstrated with fluorescein angiography (FA). The disorder is self-limited in the majority of patients, who also regain excellent vision. Occasionally, the neurosensory detachment persists and leads to pigment epithelial and photoreceptor damage with visual impairment.
The purpose of this clinical study is report the use of intravitreal bevacizumab is a new option in the treatment of the chronic or recurrent CSC.
- Conditions
- Central Serous Chorioretinopathy
- Being tested
- Intravitreal injection of Bevacizumab
- Medical subject headings
- Central Serous Chorioretinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal injection of 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 startApr 2006
- Primary completionApr 2006
- Study completionAug 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 Central Serous ChorioretinopathyStudies 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
- 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
- Investigators
- Mitzy E Torres Soriano, MD, Principal investigator, Asociación para Evitar la Ceguera en México
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00418431
- Sponsor's protocol ID
- APEC-0016
- Status last verified
- Jun 2024
- First submitted
- 3 Jan 2007
- Last updated
- 5 Jun 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Bevacizumab for the Treatment of Central Serous Chorioretinopathy
- ClinicalTrials.gov ID
- NCT00418431
- Acronym / sponsor ID
- APEC-0016
- Conditions
- Central Serous Chorioretinopathy
- Phase
- Phase 2/3
- 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
- Apr 2006 (actual)
- Primary completion
- Apr 2006 (actual)
- Study completion
- Aug 2006 (actual)
- 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.
Central serous chorioretinopathy (CSC) has been known since it was first described by Von Graefe and termed "idiopathic detachment of the macula" in 1866, is a well-characterized disorder leading to serous neurosensory elevation of the central macula. The acute form of the disease is associated with focal leakage at the level of the retinal pigment epithelium (RPE) demonstrated with fluorescein angiography (FA). The disorder is self-limited in the majority of patients, who also regain excellent vision. Occasionally, the neurosensory detachment persists and leads to pigment epithelial and photoreceptor damage with visual impairment.
The purpose of this clinical study is report the use of intravitreal bevacizumab is a new option in the treatment of the chronic or recurrent CSC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Any visual acuity.
- Central serous chorioretinopathy
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 |
|---|---|---|
| Intravitreal injection of Bevacizumab | 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 5 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.
Mitzy E Torres Soriano, 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 2/3 study testing Intravitreal injection of Bevacizumab in people with Central Serous Chorioretinopathy, 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 2 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 5 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 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 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 5 Jun 2024.