Diabetic Macular EdemaPhase 2NCT02663141
Randomized Clinical Trial of Intravitreal Bevacizumab Versus Intravitreal Bevacizumab Combined With Losartan in the Treatment of Diabetic Macular Edema
A Phase 2 study testing Losartan and Intravitreal bevacizumab in people with Diabetic Macular Edema, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
The aim of this study is to determine whether oral losartan is effective in the treatment of diabetic macular edema (DME) as an adjuvant for intravitreal bevacizumab (IVB). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Losartan and Intravitreal bevacizumab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteIran
- Study dates
- Jun 2015to Jun 2016
- Phase
- Phase 2
- 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
- All type 2 diabetes mellitus patients with clinically significant macular edema(CSME), except those mentioned as exclusion criteria
Who cannot join
- Patients with Uncontrolled hypertension
- Patients with Proliferative diabetic retinopathy
- Patients Who received angiotensin converting enzyme inhibitor(ACEI) or angiotensin receptor blocker(ARB)
- Previous treatment for diabetic retinopathy (e.g., laser photocoagulation, photodynamic therapy, intravitreal injections of steroids, or anti-vascular endothelial growth factor, retinal surgery)
- media opacities
- evidence of any other ocular disease(e.g., glaucoma, uveitis, age related macular degeneration or etc.,)
Show all 9Show fewer
- Pathologic myopia > 6 Diopter
- Patients with poor fixation or cooperation
- Patients with renal or cardiac disease
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to determine whether oral losartan is effective in the treatment of diabetic macular edema (DME) as an adjuvant for intravitreal bevacizumab (IVB).
- Conditions
- Diabetic Macular Edema
- Being tested
- Losartan, Intravitreal bevacizumab, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LosartanDrug
Intravitreal bevacizumabDrug
Also called Avastin
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Losartan | Experimental | Oral losartan 50 mg daily for 6 months Receives: Drug: Losartan; Drug: Intravitreal bevacizumab |
| Placebo | Placebo comparator | Oral placebo daily for 6 months Receives: Drug: Intravitreal bevacizumab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in ETDRS best-corrected visual acuity (BCVA) between arms
Measured: Within 6 months from therapy
Difference in frequency of intravitreal Bevacizumab injection between arms
Measured: Within 6 months from therapy
Secondary outcomes (1)
change in central macular thickness(measured by spectral domain optical coherence tomography)
Measured: Within 6 months from therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startJun 2015
- Primary completionJun 2016
- Study completionJun 2016
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Farabi Eye Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02663141
- Sponsor's protocol ID
- 9111257006
- Status last verified
- Jul 2016
- First submitted
- 21 Jan 2016
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Intravitreal Bevacizumab Versus Intravitreal Bevacizumab Combined With Losartan in the Treatment of Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT02663141
- Acronym / sponsor ID
- 9111257006
- Conditions
- Diabetic Macular Edema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Collaborators
- Farabi Eye Hospital
- Study start
- Jun 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 26 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.
The aim of this study is to determine whether oral losartan is effective in the treatment of diabetic macular edema (DME) as an adjuvant for intravitreal bevacizumab (IVB).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Losartan | Experimental | Drug: Losartan, Drug: Intravitreal bevacizumabOral losartan 50 mg daily for 6 months |
| Placebo | Placebo comparator | Drug: Intravitreal bevacizumab, Drug: PlaceboOral placebo daily for 6 months |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All type 2 diabetes mellitus patients with clinically significant macular edema(CSME), except those mentioned as exclusion criteria
Key exclusion criteria (9 listed)
- Patients with Uncontrolled hypertension
- Patients with Proliferative diabetic retinopathy
- Patients Who received angiotensin converting enzyme inhibitor(ACEI) or angiotensin receptor blocker(ARB)
- Previous treatment for diabetic retinopathy (e.g., laser photocoagulation, photodynamic therapy, intravitreal injections of steroids, or anti-vascular endothelial growth factor, retinal surgery)
- 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 |
|---|---|---|
| Losartan | Drug | Losartan |
| Intravitreal bevacizumabAlso: Avastin | Drug | Losartan, Placebo |
| Placebo | Drug | Placebo |
Primary outcome
difference in ETDRS best-corrected visual acuity (BCVA) between arms
Time frame: Within 6 months from therapy
Difference in frequency of intravitreal Bevacizumab injection between arms
Time frame: Within 6 months from therapy
1 secondary outcome
change in central macular thickness(measured by spectral domain optical coherence tomography)
Time frame: Within 6 months from therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 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.
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 2 study testing Losartan and Intravitreal bevacizumab in people with Diabetic Macular Edema, run by Tehran 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 1 inclusion and 9 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: finished, as of the sponsor's last update on 6 Jul 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
difference in ETDRS best-corrected visual acuity (BCVA) between arms (time frame: Within 6 months from therapy). The study lists 2 primary outcomes in all. 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 6 Jul 2016.