Diabetic Macular EdemaPhase 2/3NCT02645734
The Effect of Bevacizumab and Ziv-aflibercept in Diabetic Macular Edema
A Phase 2/3 study testing bevacizumab, ziv-aflibercept 1.25 mg and ziv-aflibercept 2.5mg in people with Diabetic Macular Edema, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
In this double clinical trial 132 patient with the history of DME (Diabetic Macular Edema) to receive intravitreous bevacizumab at a dose of 1.25mg (44 patient) , ziv-aflibercept at dose of 1.25 mg (44 patient) , ziv-aflibercept at dose of 2.5 mg (44 patient) . Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- bevacizumab, ziv-aflibercept 1.25 mg and ziv-aflibercept 2.5mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteIran
- Study dates
- Start not givento Feb 2016
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patient at least 18 years old had type 1 or 2 diabetes who presented with Central DME involvement (defined as retinal thickening involving 1mm central sub field thickness(CCT)
- Have at least a BCVA ( best corrected visual acuity) between 20/50 to 20/320 Snellen equivalent
- Have received to anti-VEGF( anti -vascular endothelial growth factor) and laser treatment within the previous 3 months
Who cannot join
- Uncontrolled glaucoma/uncontrolled diabet , high risk PRP(pan-retinal photocoagulation), one eye
- Prior treatment with intravitreal or peribulbar injection and laser therapy during the last 3 months
- Substantial cataract, history of uveitis
- Macular edema due to a cause other than DME
- VMT(Vitreomacular traction ) and ERM (epiretinal membrane)
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Islamic Republic of Iran
Tehran
Masoud Soheilian, MD, 009822591616, labbafi@hotmail.com
About this study
Official title: The Comparison Between the Therapeutic Effect of Intravitreal Bevacizumab and Ziv-aflibercept in Diabetic Macular Edema
In this double clinical trial 132 patient with the history of DME (Diabetic Macular Edema) to receive intravitreous bevacizumab at a dose of 1.25mg (44 patient) , ziv-aflibercept at dose of 1.25 mg (44 patient) , ziv-aflibercept at dose of 2.5 mg (44 patient) .
The study drugs were administered as often as every 4 weeks for 3 months.monitoring of best-corrected visual acuity, CST ( Central Subfield Thickness) by OCT (Optical coherence tomography) was done from base line ,4 weeks, 8weeks after injection.
- Conditions
- Diabetic Macular Edema
- Being tested
- bevacizumab, ziv-aflibercept 1.25 mg, ziv-aflibercept 2.5mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumabDrug
1.25 mg of bevacizumab is injected
ziv-aflibercept 1.25 mgDrug
1.25 mg of ziv-aflibercept is injected
ziv-aflibercept 2.5mgDrug
2.5 mg of ziv-aflibercept is injected
| Study group | Role | What they receive |
|---|---|---|
| Injection intravitreous bevacizumab | Active comparator | Injection intravitreous bevacizumab at a dose 1.25mg Receives: Drug: bevacizumab |
| Injection ziv-aflibercept at dose of 1.25 mg | Active comparator | Injection ziv-aflibercept at dose of 1.25 mg Receives: Drug: ziv-aflibercept 1.25 mg |
| Injection ziv-aflibercept at dose of 2.5 mg | Active comparator | Injection ziv-aflibercept at dose of 2.5 mg Receives: Drug: ziv-aflibercept 2.5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual acuity
Measured: until 6 month
Secondary outcomes (1)
central subfield thickness(CCT)
Measured: until 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2016 (estimated)
- Primary completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 133 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02645734
- Sponsor's protocol ID
- 93210
- Status last verified
- Oct 2015
- First submitted
- 2 Jan 2016
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison Between the Therapeutic Effect of Intravitreal Bevacizumab and Ziv-aflibercept in Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT02645734
- Acronym / sponsor ID
- 93210
- Conditions
- Diabetic Macular Edema
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 133 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Primary completion
- Feb 2016 (estimated)
- First posted
- 5 Jan 2016 (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.
In this double clinical trial 132 patient with the history of DME (Diabetic Macular Edema) to receive intravitreous bevacizumab at a dose of 1.25mg (44 patient) , ziv-aflibercept at dose of 1.25 mg (44 patient) , ziv-aflibercept at dose of 2.5 mg (44 patient) .
The study drugs were administered as often as every 4 weeks for 3 months.monitoring of best-corrected visual acuity, CST ( Central Subfield Thickness) by OCT (Optical coherence tomography) was done from base line ,4 weeks, 8weeks after injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Injection intravitreous bevacizumab | Active comparator | Drug: bevacizumabInjection intravitreous bevacizumab at a dose 1.25mg |
| Injection ziv-aflibercept at dose of 1.25 mg | Active comparator | Drug: ziv-aflibercept 1.25 mgInjection ziv-aflibercept at dose of 1.25 mg |
| Injection ziv-aflibercept at dose of 2.5 mg | Active comparator | Drug: ziv-aflibercept 2.5mgInjection ziv-aflibercept at dose of 2.5 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patient at least 18 years old had type 1 or 2 diabetes who presented with Central DME involvement (defined as retinal thickening involving 1mm central sub field thickness(CCT)
- Have at least a BCVA ( best corrected visual acuity) between 20/50 to 20/320 Snellen equivalent
- Have received to anti-VEGF( anti -vascular endothelial growth factor) and laser treatment within the previous 3 months
Key exclusion criteria (5 listed)
- Uncontrolled glaucoma/uncontrolled diabet , high risk PRP(pan-retinal photocoagulation), one eye
- Prior treatment with intravitreal or peribulbar injection and laser therapy during the last 3 months
- Substantial cataract, history of uveitis
- Macular edema due to a cause other than DME
- VMT(Vitreomacular traction ) and ERM (epiretinal membrane)
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 |
|---|---|---|
| bevacizumab1.25 mg of bevacizumab is injected | Drug | Injection intravitreous bevacizumab |
| ziv-aflibercept 1.25 mg1.25 mg of ziv-aflibercept is injected | Drug | Injection ziv-aflibercept at dose of 1.25 mg |
| ziv-aflibercept 2.5mg2.5 mg of ziv-aflibercept is injected | Drug | Injection ziv-aflibercept at dose of 2.5 mg |
Primary outcome
visual acuity
Time frame: until 6 month
1 secondary outcome
central subfield thickness(CCT)
Time frame: until 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing bevacizumab, ziv-aflibercept 1.25 mg and ziv-aflibercept 2.5mg in people with Diabetic Macular Edema, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 5 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 5 Jan 2016. 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 Iran. 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 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?
Contact Masoud Soheilian, MD (009822591616, labbafi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual acuity (time frame: until 6 month). 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 5 Jan 2016.