Macular EdemaPhase 2/3NCT00703235
Intravitreal Bevacizumab for Diabetic Macular Edema
A Phase 2/3 study testing Bevacizumab in people with Macular Edema and Diabetic Retinopathy, run by Isfahan Ophthalmology Research Center.
Trial summary
Diabetic macular edema is a common cause of visual loss among diabetic patients. Studies have demonstrated the role of vascular endothelial growth factor (VEGF) in the pathogenesis of edema. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Macular Edema, Diabetic Retinopathy
- What is being tested?
- Bevacizumab
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diabetes mellitus
- Clinically significant macular edema
- Possibility of performing macular OCT
- Consent of patient for inclusion in the study
Who cannot join
- History of macular photocoagulation in less than 6 months of inclusion in the study
- Necessity of surgical intervention
- Rejection of the remaining in the study by patient
About this study
Diabetic macular edema is a common cause of visual loss among diabetic patients. Studies have demonstrated the role of vascular endothelial growth factor (VEGF) in the pathogenesis of edema.
This study designed to evaluate the effect of Intravitreal injection of a recombinant monoclonal anti-VEGF antibody, Bevacizumab, for treatment of diabetic macular edema.
- Conditions
- Macular Edema, Diabetic Retinopathy
- Being tested
- Bevacizumab
- Medical subject headings
- Macular Edema, Diabetic Retinopathy
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 posted23 Jun 2008 (estimated)
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 2/3
Sponsor and investigators
- Lead sponsor
- Isfahan Ophthalmology Research Center
- Sponsor type
- Research network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00703235
- Sponsor's protocol ID
- MUI - clinical - 185290
- Status last verified
- Jun 2008
- First submitted
- 20 Jun 2008
- Last updated
- 23 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Bevacizumab for Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT00703235
- Acronym / sponsor ID
- MUI - clinical - 185290
- Conditions
- Macular Edema, Diabetic Retinopathy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Isfahan Ophthalmology Research CenterResearch network
- First posted
- 23 Jun 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.
Diabetic macular edema is a common cause of visual loss among diabetic patients. Studies have demonstrated the role of vascular endothelial growth factor (VEGF) in the pathogenesis of edema.
This study designed to evaluate the effect of Intravitreal injection of a recombinant monoclonal anti-VEGF antibody, Bevacizumab, for treatment of diabetic macular edema.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Diabetes mellitus
- Clinically significant macular edema
- Possibility of performing macular OCT
- Consent of patient for inclusion in the study
Key exclusion criteria (3 listed)
- History of macular photocoagulation in less than 6 months of inclusion in the study
- Necessity of surgical intervention
- Rejection of the remaining in the study by patient
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Bevacizumab in people with Macular Edema and Diabetic Retinopathy, run by Isfahan Ophthalmology Research Center.
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: status not confirmed, as of the sponsor's last update on 23 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
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.
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 23 Jun 2008.