Cystoid Macular EdemaPhase 3NCT00406172
Intravitreal Bevacizumab (Avastin) for Pseudophakic Macular Edema (PME)
A Phase 3 study testing Bevacizumab in people with Cystoid Macular Edema, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
Trial summary
To report safety and efficacy of intravitreal injection of bevacizumab in patients with cystoid macular edema secondary to cataract surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cystoid Macular Edema
- What is being tested?
- Bevacizumab
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- Nov 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 Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Pseudophakic eyes with macular edema
Who cannot join
- Other retinopathies
Trial locations and contacts
1 site in 1 country.
About this study
To report safety and efficacy of intravitreal injection of bevacizumab in patients with cystoid macular edema secondary to cataract surgery.
- Conditions
- Cystoid Macular Edema
- Being tested
- Bevacizumab
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
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 startNov 2006
- Primary completionNov 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 Cystoid Macular EdemaStudies 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
- Victoria Cubas-Lorenzo, MD, Principal investigator, APEC México
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00406172
- Sponsor's protocol ID
- APEC 0016
- Status last verified
- Jun 2024
- First submitted
- 30 Nov 2006
- 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 (Avastin) for Pseudophakic Macular Edema (PME)
- ClinicalTrials.gov ID
- NCT00406172
- Acronym / sponsor ID
- APEC 0016
- Conditions
- Cystoid Macular Edema
- 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
- Nov 2006 (actual)
- Primary completion
- Nov 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.
To report safety and efficacy of intravitreal injection of bevacizumab in patients with cystoid macular edema secondary to cataract surgery.
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 (1 listed)
- Pseudophakic eyes with macular edema
Key exclusion criteria (1 listed)
- Other retinopathies
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 | – |
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.
Related trials for Cystoid Macular Edema
Active, not recruitingPhase 2
Multicenter Study on the Efficacy and Safety of OCS-01 in Subjects With Uveitis Related and Post Surgical Macular Edema
Uveitis Related Cystoid Macular Edema, Cystoid Macular Edema, Postoperative
Not yet recruitingObservational study
OCT Macula Biomarkers Before Silicone Oil Removal and Visual Outcome After Silicone Oil Removal
Retinal Detachment, Macular Edema
RecruitingPhase 1/2
Therapeutic Contact Lens Drug Delivery System (TCL-DDS) in Patients With Recurrent Cystoid Macular Edema
Cystoid Macular Edema
Recruiting
Effect of Video Viewing on Intravitreal Injection Experience
Age Related Macular Degeneration, Diabetic Retinopathy
Enrolling by invitationPhase 3
Intravitreal and Intracameral DEX in NPDR
Non-Proliferative Diabetic Retinopathy
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.
Victoria Cubas-Lorenzo, MD principal investigator
APEC 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 in people with Cystoid Macular Edema, 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 1 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 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 5 Jun 2024.