Macular EdemaPhase 4NCT00801866
Avastin for Post-photocoagulation Macular Edema
A Phase 4 study testing Bevacizumab and Panretinal Photocoagulation in people with Macular Edema, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
Trial summary
to evaluate the efficacy of a single intravitreal bevacizumab (IVB) injection, 0.1mL (2.5mg), against panretinal photocoagulation (PRP)-induced macular thickening and visual disturbance in patients with severe nonproliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR) and good vision Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Macular Edema
- What is being tested?
- Bevacizumab and Panretinal Photocoagulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- Dec 2008to Dec 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 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with Proliferative retinopathy or severe non-proliferative retinopathy
- BCVA of 20/63 or better (56 ETDRS letters
- No history of Macular Edema
- Central Retinal Thickness of 250mics or more
Who cannot join
- Previous treatment.
- Other ophthalmic diseases. history of Nephropathy, heart diseases and pregnancy
- Media opacities
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Asociación para Evitar la Ceguera en México
Mexico City, Mexico City, 04030
About this study
Official title: Prevention of Post-photocoagulation Macular Edema by Intravitreal Bevacizumab.
to evaluate the efficacy of a single intravitreal bevacizumab (IVB) injection, 0.1mL (2.5mg), against panretinal photocoagulation (PRP)-induced macular thickening and visual disturbance in patients with severe nonproliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR) and good vision
- Conditions
- Macular Edema
- Being tested
- Bevacizumab, Panretinal Photocoagulation
- Keywords
- Panretinal Photocoagulation, Macular Edema, Intravitreal 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
Intravitreal administration
Panretinal PhotocoagulationProcedure or surgery
Panretinal Photocoagulation
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Panretinal Photocoagulation + Bevacizumab Receives: Drug: Bevacizumab |
| Group 2 | Experimental | Panretinal Photocoagulation Receives: Procedure: Panretinal Photocoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Visual Acuity
Secondary outcomes (1)
Central Retinal Thickness.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionDec 2008
- Study completionDec 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
- 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
- Eduarto Torres-Porras, MD, Study director, Asociación para Evitar la Ceguera en MéxicoOctavio Burgos, MD, Principal investigator, Asociación para Evitar la Ceguera en México
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801866
- Sponsor's protocol ID
- APEC-035
- Status last verified
- May 2024
- First submitted
- 3 Dec 2008
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
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
- Prevention of Post-photocoagulation Macular Edema by Intravitreal Bevacizumab.
- ClinicalTrials.gov ID
- NCT00801866
- Acronym / sponsor ID
- APEC-035
- Conditions
- Macular Edema
- Keywords
- Panretinal Photocoagulation, Macular Edema, Intravitreal Bevacizumab
- Phase
- Phase 4
- 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 2008 (actual)
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 4 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.
to evaluate the efficacy of a single intravitreal bevacizumab (IVB) injection, 0.1mL (2.5mg), against panretinal photocoagulation (PRP)-induced macular thickening and visual disturbance in patients with severe nonproliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR) and good vision
Study design
- Primary purpose
- Treatment
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: BevacizumabPanretinal Photocoagulation + Bevacizumab |
| Group 2 | Experimental | Procedure: Panretinal PhotocoagulationPanretinal Photocoagulation |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with Proliferative retinopathy or severe non-proliferative retinopathy
- BCVA of 20/63 or better (56 ETDRS letters
- No history of Macular Edema
- Central Retinal Thickness of 250mics or more
Key exclusion criteria (3 listed)
- Previous treatment.
- Other ophthalmic diseases. history of Nephropathy, heart diseases and pregnancy
- Media opacities
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 administration | Drug | Group 1 |
| Panretinal PhotocoagulationPanretinal Photocoagulation | Procedure or surgery | Group 2 |
Primary outcome
Best Corrected Visual Acuity
1 secondary outcome
Central Retinal Thickness.
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 Macular Edema
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Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edema
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A Randomized, Phase 2 Study of Oral BGE-102 in Participants With Center-Involved Diabetic Macular Edema
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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.
Eduarto Torres-Porras, MD study director
Asociación para Evitar la Ceguera en México
Octavio Burgos, 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 4 study testing Bevacizumab and Panretinal Photocoagulation 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 4 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 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 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. 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.