Diffuse Diabetic Macular EdemaPhase 1NCT00999791
Intravitreal Diclofenac Versus Avastin as Primary Treatment of Diffuse Diabetic Macular Edema
A Phase 1 study testing Bevacizumab and Diclofenac in people with Diffuse Diabetic Macular Edema, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
Diffuse Macular Edema is the main cause of visual disorders in diabetic patients. Diclofenac is a cheap drug available in most of treatment centers.in animal studies the safe dosage is identified that can be used in diffuse diabetic macular edema for treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diffuse Diabetic Macular Edema
- What is being tested?
- Bevacizumab and Diclofenac
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteIran
- Study dates
- Jul 2009to not given
- Phase
- Phase 1
- 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
- Child, Adult, Older adult
Who may be able to join
- patients with clinically significant macular edema and diffuse macular edema
Who cannot join
- any history of focal photocoagulation
- any prior intra ocular injection
- history of glaucoma with high pressure
- history of ophthalmic surgery
- high rish PDR
- active PDR
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Ophthalmic Research Center
Tehran, Tehran Province, 166666
Masoud Soheilian, MD, +98 21 22585952, labbafi@hotmail.com
About this study
Diffuse Macular Edema is the main cause of visual disorders in diabetic patients.
Diclofenac is a cheap drug available in most of treatment centers.in animal studies the safe dosage is identified that can be used in diffuse diabetic macular edema for treatment. in this study, we are going to compare the effect of intra vitreal injection of Diclofenac and Bevacizumab in primary treatment of diffuse diabetic macular edema.
Read the detailed description
Diffuse Macular Edema is the main cause of visual disorders in diabetic patients.
Diclofenac is a cheap drug available in most of treatment centers.in animal studies the safe dosage is identified that can be used in diffuse diabetic macular edema for treatment. in this study, we are going to compare the effect of intra vitreal injection of Diclofenac and Bevacizumab in primary treatment of diffuse diabetic macular edema.
- Conditions
- Diffuse Diabetic Macular Edema
- Being tested
- Bevacizumab, Diclofenac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
DiclofenacDrug
| Study group | Role | What they receive |
|---|---|---|
| Avastin | Active comparator | Not described Receives: Drug: Bevacizumab |
| Diclofenac | Active comparator | Not described Receives: Drug: Diclofenac |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2009 (estimated)
- Study startJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse 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 1
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999791
- Sponsor's protocol ID
- 8818
- Status last verified
- Oct 2009
- First submitted
- 7 Jul 2009
- Last updated
- 4 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Diclofenac Versus Avastin as Primary Treatment of Diffuse Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT00999791
- Acronym / sponsor ID
- 8818
- Conditions
- Diffuse Diabetic Macular Edema
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Jul 2009
- First posted
- 22 Oct 2009 (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.
Diffuse Macular Edema is the main cause of visual disorders in diabetic patients.
Diclofenac is a cheap drug available in most of treatment centers.in animal studies the safe dosage is identified that can be used in diffuse diabetic macular edema for treatment. in this study, we are going to compare the effect of intra vitreal injection of Diclofenac and Bevacizumab in primary treatment of diffuse diabetic macular edema.
Detailed description
Diffuse Macular Edema is the main cause of visual disorders in diabetic patients.
Diclofenac is a cheap drug available in most of treatment centers.in animal studies the safe dosage is identified that can be used in diffuse diabetic macular edema for treatment. in this study, we are going to compare the effect of intra vitreal injection of Diclofenac and Bevacizumab in primary treatment of diffuse diabetic macular edema.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Avastin | Active comparator | Drug: Bevacizumab |
| Diclofenac | Active comparator | Drug: Diclofenac |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with clinically significant macular edema and diffuse macular edema
Key exclusion criteria (6 listed)
- any history of focal photocoagulation
- any prior intra ocular injection
- history of glaucoma with high pressure
- history of ophthalmic surgery
- high rish PDR
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 | Avastin |
| Diclofenac | Drug | Diclofenac |
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 4 May 2010.
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 1 study testing Bevacizumab and Diclofenac in people with Diffuse 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 6 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 4 May 2010. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 (+982122585952, labbafi@hotmail.com), or a site near the patient. 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 4 May 2010.