Macular EdemaPhase 4NCT00804206
Comparison of the Effects of Bevacizumab Before vs After Pattern Panretinal Photocoagulation
A Phase 4 study testing bevacizumab in people with Macular Edema, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
Trial summary
Compare the effect of an intravitreal injection of bevacizumab previous or posterior of panretinal laser photocoagulation (PRLP) with a pattern laser; to prevent and reduce diabetic macular edema (DME) in patients with proliferative diabetic retinopathy (PDR) with DME. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Macular Edema
- What is being tested?
- bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteMexico
- Study dates
- Jul 2008to Jul 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with proliferative diabetic retinopathy
- patients with macular edema
Who cannot join
- patients with previous treatments
- patients with ocular surgeries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 4 Comparison of the Effects of Bevacizumab Before vs After Pattern Panretinal Photocoagulation
Compare the effect of an intravitreal injection of bevacizumab previous or posterior of panretinal laser photocoagulation (PRLP) with a pattern laser; to prevent and reduce diabetic macular edema (DME) in patients with proliferative diabetic retinopathy (PDR) with DME.
- Conditions
- Macular Edema
- Being tested
- bevacizumab
- Keywords
- Intravitreal injection of Bevacizumab, Visual acuity, central retinal thickness, color studies, Farnsworth-Munsell, electroretinogram studies
- 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
Intravitreal bevacizumab before panretinal photocoagulation
bevacizumabDrug
Intravitreal Bevacizumab after panretinal photocoagulation
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Bevacizumab before panretinal photocoagulation. Receives: Drug: bevacizumab |
| Group B | Experimental | Bevacizumab after panretinal photocoagulation Receives: Drug: bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central macular thickness
Measured: baseline, 10 days, 52 days, 85 days
Secondary outcomes (1)
Best corrected visual acuity
Measured: baseline, 10 days, 52 days, 85 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2008 (estimated)
- Study startJul 2008
- Primary completionJul 2008
- Study completionJul 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
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asociación para Evitar la Ceguera en México
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00804206
- Sponsor's protocol ID
- APEC-040
- Status last verified
- May 2024
- First submitted
- 3 Dec 2008
- 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
- Phase 4 Comparison of the Effects of Bevacizumab Before vs After Pattern Panretinal Photocoagulation
- ClinicalTrials.gov ID
- NCT00804206
- Acronym / sponsor ID
- APEC-040
- Conditions
- Macular Edema
- Keywords
- Intravitreal injection of Bevacizumab, Visual acuity, central retinal thickness, color studies, Farnsworth-Munsell, electroretinogram studies
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: undefined
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Asociación para Evitar la Ceguera en MéxicoUniversity, hospital or other
- Study start
- Jul 2008 (actual)
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 8 Dec 2008 (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.
Compare the effect of an intravitreal injection of bevacizumab previous or posterior of panretinal laser photocoagulation (PRLP) with a pattern laser; to prevent and reduce diabetic macular edema (DME) in patients with proliferative diabetic retinopathy (PDR) with DME.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: bevacizumabBevacizumab before panretinal photocoagulation. |
| Group B | Experimental | Drug: bevacizumabBevacizumab after panretinal photocoagulation |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with proliferative diabetic retinopathy
- patients with macular edema
Key exclusion criteria (2 listed)
- patients with previous treatments
- patients with ocular surgeries
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 |
|---|---|---|
| bevacizumabIntravitreal bevacizumab before panretinal photocoagulation | Drug | Group A |
| bevacizumabIntravitreal Bevacizumab after panretinal photocoagulation | Drug | Group B |
Primary outcome
Central macular thickness
Time frame: baseline, 10 days, 52 days, 85 days
1 secondary outcome
Best corrected visual acuity
Time frame: baseline, 10 days, 52 days, 85 days
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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with 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 2 inclusion and 2 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?
Central macular thickness (time frame: baseline, 10 days, 52 days, 85 days). 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.