Diabetic Macular EdemaPhase 3NCT00370669
Effect of Intravitreal Bevacizumab on Clinically Significant Macular Edema
A Phase 3 study testing bevacizumab and triamcinolone acetonide in people with Diabetic Macular Edema, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
to compare the effect of intravitreal bevacizumab alone or in combination with triamcinolone acetonide with laser photocoagulation on clinically significant macular edema (CSME) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- bevacizumab and triamcinolone acetonide
- How many people
- 150 participants
- Where
- 1 siteIran
- Study dates
- Nov 2005to Feb 2007
- Phase
- Phase 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
- case with clear media IOP below 23 mm/Hg female after menopause at least for 12 months or had 2 contraceptive roots visual acuity between 20/50 to 20/320
Who cannot join
- no PRP or N.d YAG laser in past 6 months no intraocular surgery in past 12 months
- CVA in past 12 months blood sugar above 250
- active infection in extraocular adnexa
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Masoud Soheilian
Tehran, Tehran Province, 16666
Masoud Soheilian, MD, +98 21 22585952, labbafi@hotmail.com
About this study
to compare the effect of intravitreal bevacizumab alone or in combination with triamcinolone acetonide with laser photocoagulation on clinically significant macular edema (CSME)
Read the detailed description
we entered 150 eyes into the study that recruitment of cases finished recently.Eligible eyes randomly assign to one of the study arms including intravitreal bevacizumzb, intravitreal bevacizumzb/triamcinolone and macular photocoagulation groups. Every patient needs at least 1 year followup. During this time BCVA, OCT, FA will be done for each patient and inaccording to interpretation of datas and fundus exam repeatation of injection will be done.
- Conditions
- Diabetic Macular Edema
- Being tested
- bevacizumab, triamcinolone acetonide
- Keywords
- Bevacizumab, CSME, MPC, Triamcinolone acetonide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumabDrug
triamcinolone acetonideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
visual acuity
central macular thickness
Secondary outcomes (4)
Leakage in fluorescein angiography
intraocular pressure
cataract progression
anterior chamber reaction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2006 (estimated)
- Study startNov 2005
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Masoud Soheilian, Principal investigator, Ophthalmic Research Center of Shaheed Beheshti Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00370669
- Sponsor's protocol ID
- 8411
- Status last verified
- Feb 2007
- First submitted
- 30 Aug 2006
- Last updated
- 22 Feb 2007
- Results posted
- No
Publications
Soheilian M, Garfami KH, Ramezani A, Yaseri M, Peyman GA. Two-year results of a randomized trial of intravitreal bevacizumab alone or combined with triamcinolone versus laser in diabetic macular edema. Retina. 2012 Feb;32(2):314-21. doi: 10.1097/IAE.0b013e31822f55de.
PubMed 22234244Soheilian M, Ramezani A, Obudi A, Bijanzadeh B, Salehipour M, Yaseri M, Ahmadieh H, Dehghan MH, Azarmina M, Moradian S, Peyman GA. Randomized trial of intravitreal bevacizumab alone or combined with triamcinolone versus macular photocoagulation in diabetic macular edema. Ophthalmology. 2009 Jun;116(6):1142-50. doi: 10.1016/j.ophtha.2009.01.011. Epub 2009 Apr 19.
PubMed 19376585
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravitreal Bevacizumab on Clinically Significant Macular Edema
- ClinicalTrials.gov ID
- NCT00370669
- Acronym / sponsor ID
- 8411
- Conditions
- Diabetic Macular Edema
- Keywords
- Bevacizumab, CSME, MPC, Triamcinolone acetonide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Nov 2005
- Study completion
- Feb 2007
- First posted
- 1 Sep 2006 (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 compare the effect of intravitreal bevacizumab alone or in combination with triamcinolone acetonide with laser photocoagulation on clinically significant macular edema (CSME)
Detailed description
we entered 150 eyes into the study that recruitment of cases finished recently.Eligible eyes randomly assign to one of the study arms including intravitreal bevacizumzb, intravitreal bevacizumzb/triamcinolone and macular photocoagulation groups. Every patient needs at least 1 year followup. During this time BCVA, OCT, FA will be done for each patient and inaccording to interpretation of datas and fundus exam repeatation of injection will be done.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- case with clear media IOP below 23 mm/Hg female after menopause at least for 12 months or had 2 contraceptive roots visual acuity between 20/50 to 20/320
Key exclusion criteria (3 listed)
- no PRP or N.d YAG laser in past 6 months no intraocular surgery in past 12 months
- CVA in past 12 months blood sugar above 250
- active infection in extraocular adnexa
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 | – |
| triamcinolone acetonide | Drug | – |
Primary outcome
visual acuity
central macular thickness
4 secondary outcomes
Leakage in fluorescein angiography
intraocular pressure
cataract progression
anterior chamber reaction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2007.
- Derived from this study: PubMed 22234244Soheilian M, Garfami KH, Ramezani A, Yaseri M, Peyman GA. Two-year results of a randomized trial of intravitreal bevacizumab alone or combined with triamcinolone versus laser in diabetic macular edema. Retina. 2012 Feb;32(2):314-21. doi: 10.1097/IAE.0b013e31822f55de.
- Derived from this study: PubMed 19376585Soheilian M, Ramezani A, Obudi A, Bijanzadeh B, Salehipour M, Yaseri M, Ahmadieh H, Dehghan MH, Azarmina M, Moradian S, Peyman GA. Randomized trial of intravitreal bevacizumab alone or combined with triamcinolone versus macular photocoagulation in diabetic macular edema. Ophthalmology. 2009 Jun;116(6):1142-50. doi: 10.1016/j.ophtha.2009.01.011. Epub 2009 Apr 19.
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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.
Masoud Soheilian principal investigator
Ophthalmic Research Center of Shaheed Beheshti Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bevacizumab and triamcinolone acetonide 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 1 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 22 Feb 2007. 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 phase mean?
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 (+98 21 22585952, 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. 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?
On the ClinicalTrials.gov record for NCT00370669, which also lists 2 linked publications.
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 22 Feb 2007; AzTrials last refreshed its copy on 7 Nov 2026.