Macular EdemaPhase 4MECROVNCT00566761

Treatment of Bevacizumab and Triamcinolone in Treatment or Macular Edema Secondary to CRVO

A Phase 4 study testing bevacizumab and triamcinolone in people with Macular Edema and Central Retinal Vein Occlusion, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Treatment of macular edema secondary to central retinal vein occlusion is more effective with combined therapy of bevacizumab and triamcinolone than bevacizumab alone. Read more about this study

Who is it for?: Any age
Conditions the study is for: Macular Edema, Central Retinal Vein Occlusion
What is being tested?: bevacizumab and triamcinolone
How many people: 10 participants
Where: 1 siteMexico
Study dates: Jun 2007to Mar 2008
Phase: Phase 4
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
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Macular edema secondary to central retinal vein occlusion
BCVA worse than 20/40
Central macular >250 mc with OCT

Who cannot join

Diabetic retinopathy or other retinopathy
Media opacity that does not allow following
steroid responder
diagnosed glaucoma or IOP > 21 mmHg

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Asociacion Para Evitar la Ceguera en Mexico
Mexico City, Coyoacan, 04030

Other trials in Mexico

About this study

Official title: Combined Treatment of Intravitreous Bevacizumab and Triamcinolone for the Treatment or Macular Edema Secondary to Central Retinal Vein Occlusion

Treatment of macular edema secondary to central retinal vein occlusion is more effective with combined therapy of bevacizumab and triamcinolone than bevacizumab alone.

Read the detailed description

Comparison of two groups with different treatment with registrations of outcome in BCVA and complications

Conditions: Macular Edema, Central Retinal Vein Occlusion
Being tested: bevacizumab and triamcinolone
Keywords: Macular edema, central retinal vein occlusion, bevacizumab, triamcinolone
Medical subject headings: Macular Edema, Retinal Vein Occlusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

bevacizumab and triamcinoloneDrug
three applications monthly administrated of bevacizumab 2.5mg for group 1 and bevacizumab 2.5 mg + triamcinolone 4mg first dose followed by two of bevacizumab alone for the group 2

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in Best corrected visual acuity and macular edema measured with OCT
Measured: Follow up to 3 , 6 and 12 months

Secondary outcomes (1)

Report treatment complications
Measured: 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2007Mar 2008

First posted4 Dec 2007 (estimated)
Study startJun 2007
Primary completionJun 2007
Study completionMar 2008

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 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00566761
Sponsor's protocol ID: MECRVO
Acronym: MECROV
Status last verified: May 2024
First submitted: 30 Nov 2007
Last updated: 30 May 2024
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Not yet recruitingObservational study
Efficacy of Aflibercept (8 mg) With Sequential Laser Photocoagulation for Macular Edema Secondary to Retinal Artery Macroaneurysm: Retrospective Study"
Retinal Arterial Macroaneurysm
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)

All Macular Edema trials

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: Combined Treatment of Intravitreous Bevacizumab and Triamcinolone for the Treatment or Macular Edema Secondary to Central Retinal Vein Occlusion
ClinicalTrials.gov ID: NCT00566761
Acronym / sponsor ID: MECROV / MECRVO
Conditions: Macular Edema, Central Retinal Vein Occlusion
Keywords: Macular edema, central retinal vein occlusion, bevacizumab, triamcinolone
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: undefined
Enrolment: 10 participants (actual)
Lead sponsor: Asociación para Evitar la Ceguera en MéxicoUniversity, hospital or other
Study start: Jun 2007 (actual)
Primary completion: Jun 2007 (actual)
Study completion: Mar 2008 (actual)
First posted: 4 Dec 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.

Treatment of macular edema secondary to central retinal vein occlusion is more effective with combined therapy of bevacizumab and triamcinolone than bevacizumab alone.

Detailed description

Comparison of two groups with different treatment with registrations of outcome in BCVA and complications

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Macular edema secondary to central retinal vein occlusion
BCVA worse than 20/40
Central macular >250 mc with OCT

Key exclusion criteria (4 listed)

Diabetic retinopathy or other retinopathy
Media opacity that does not allow following
steroid responder
diagnosed glaucoma or IOP > 21 mmHg

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 and triamcinolonethree applications monthly administrated of bevacizumab 2.5mg for group 1 and bevacizumab 2.5 mg + triamcinolone 4mg first dose followed by two of bevacizumab alone for the group 2	Drug	–

Primary outcome

Changes in Best corrected visual acuity and macular edema measured with OCT
Time frame: Follow up to 3 , 6 and 12 months

1 secondary outcome

Report treatment complications
Time frame: 12 month

Results and safety

The study was stopped early (reason given: undefined). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.

Related trials for Macular Edema

Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Not yet recruitingObservational study
Efficacy of Aflibercept (8 mg) With Sequential Laser Photocoagulation for Macular Edema Secondary to Retinal Artery Macroaneurysm: Retrospective Study"
Retinal Arterial Macroaneurysm
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)

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.

Carmen Gonzalez-Mijares, Physician principal investigator

Asociación para Evitar la Ceguera en México

Hugo Quiroz-Mercado, Retinologyst study director

Asociación para Evitar la Ceguera en México

Juan Manuel Jimenez Sierra, Retinologyst 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 4 study testing bevacizumab and triamcinolone in people with Macular Edema and Central Retinal Vein Occlusion, 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 4 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 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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: undefined). 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?

Changes in Best corrected visual acuity and macular edema measured with OCT (time frame: Follow up to 3 , 6 and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00566761.

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.