Diabetic Macular EdemaPhase 2/3NCT06595355
Efficacy and Safety of Intravitreal Injection of Bevacizumab with and Without Oral Curcumin
A Phase 2/3 study testing bevacizumab with oral curcumin in people with Diabetic Macular Edema and Macular Edema, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to evaluate the effectiveness of adding curcumin oral treatment to bevacizumab intravitreal injection in patients with central macular edema. A blind study and a randomized and controlled clinical trial are conducted on diabetic patients with macular edema. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Diabetic Macular Edema, Macular Edema, Retinal Neovascularization
- What is being tested?
- bevacizumab with oral curcumin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteIran
- Study dates
- 10 Oct 2021to 22 Sep 2025
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with center-involving macular edema with macular center thickness more than 300 microns in OCT 2-Patients who did not receive intravitreal bevacizumab in the last 3 months and intravitreal corticosteroids in the last 6 months.
- 3- The amount of BCVA should not be <20/400. 4-Consent to participate in the study
Who cannot join
- Other retinal diseases except for DME and macular edema due to other causes including uveitis, epiretinal membrane, central retinal vein occlusion, and...
- Existence of proliferative diabetic retinopathy and patients with a history of vitrectomy
- Patients with glaucoma, vitreous hemorrhage, age-related macular degeneration (ARMD)
- Media opacities that limit the interpretation of diagnostic tests
- Surgery or procedure 3 months before starting treatment
- Pregnancy or breastfeeding
Show all 12Show fewer
- History of allergy to curcumin
- Use of warfarin
- Changing the patient's clinical diagnosis or the need for surgical interventions in the course of the disease
- Change in the patient's general health condition
- Absence of patient referrals
- Lack of consent to continue treatment and follow-up
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Mohsen Pourazizi
Isfahan, Isfahan University of Medical Sciences, 8174673461
Mohsen Pourazizi, Doctor, +983134452031, m.pourazizi@yahoo.com
About this study
Official title: Efficacy and Safety of Intravitreal Injection of Bevacizumab with and Without Oral Curcumin in Diabetic Macular Edema
The purpose of this study is to evaluate the effectiveness of adding curcumin oral treatment to bevacizumab intravitreal injection in patients with central macular edema.
A blind study and a randomized and controlled clinical trial are conducted on diabetic patients with macular edema. The patients are divided into two intervention groups (bevacizumab + curcumin) and control (bevacizumab + placebo).
The evaluation of the central thickness of the macula and the evaluation of the central volume of the macula are the primary goals and the evaluation of the best visual acuity of the patient is the secondary goal.
- Being tested
- bevacizumab with oral curcumin, bevacizumab with oral placebo
- Keywords
- macular edema, diabetic macular edema, central macular edema, bevacizumab, Diabetic Retinopathy, Retinal Neovascularization
- Medical subject headings
- Macular Edema, Retinal Neovascularization, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumab with oral curcuminDrug
Also called intervention group
According to the recommendation of the American Association of Ophthalmologists, intravitreal injection of bevacizumab with a standard dose of 1.25mg/0.05ml in each group will be performed three times consecutively at one-month intervals. In the simultaneous intervention group, patients will take daily curcumin tablets (sinacurcumin product) at a dose of 40 mg twice a day for three months (at the same time as the start of bevacizumab intravitreal injection treatment).
bevacizumab with oral placeboDrug
Also called placebo
Intravitreal injection of bevacizumab with a standard dose of 1.25mg/0.05ml in each group will be performed three times consecutively at one-month intervals. In the control group, patients will be taking daily placebo tablets twice a day for three months (at the same time as the start of bevacizumab intravitreal injection treatment).
| Study group | Role | What they receive |
|---|---|---|
| Case: Intravitreal injection of bevacizumab with oral curcumin | Experimental | Intravitreal injection of bevacizumab with oral curcumin Inclusion criteria: Patients with center-involving macular edema with macular center thickness of more than 300 microns in OCT 2-Patients who did not receive intravitreal bevacizumab in the last 3 months and intravitreal corticosteroids in the previous 6 months.
3- The amount of BCVA should not be <20/400. 4-Consent to participate in the study Receives: Drug: bevacizumab with oral curcumin |
| Control: Intravitreal injection of bevacizumab with oral placebo | Placebo comparator | Intravitreal injection of bevacizumab with oral placebo Receives: Drug: bevacizumab with oral placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
central macular thickness (CMT)
Changes in central macular thickness (CMT) in patients with oral Curcumin versus patients in the control group
Measured: 3 months
central macular volume (CMV)
Changes in central macular volume (CMV) in patients with oral Curcumin versus patients in the control group
Measured: 3 months
Secondary outcomes (1)
best visual acuity (BCVA)
Changes in best visual acuity (BCVA) in patients with oral Curcumin versus patients in the control group
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start10 Oct 2021
- Primary completion22 Sep 2025 (estimated)
- Study completion22 Sep 2025 (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
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohsen Pourazizi, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595355
- Sponsor's protocol ID
- IR.ARI.MUI.REC.1402.336
- Status last verified
- Sep 2024
- First submitted
- 10 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Intravitreal Injection of Bevacizumab with and Without Oral Curcumin in Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT06595355
- Acronym / sponsor ID
- IR.ARI.MUI.REC.1402.336
- Keywords
- macular edema, diabetic macular edema, central macular edema, bevacizumab, Diabetic Retinopathy, Retinal Neovascularization
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- 10 Oct 2021 (actual)
- Primary completion
- 22 Sep 2025 (estimated)
- Study completion
- 22 Sep 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- 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 purpose of this study is to evaluate the effectiveness of adding curcumin oral treatment to bevacizumab intravitreal injection in patients with central macular edema.
A blind study and a randomized and controlled clinical trial are conducted on diabetic patients with macular edema. The patients are divided into two intervention groups (bevacizumab + curcumin) and control (bevacizumab + placebo).
The evaluation of the central thickness of the macula and the evaluation of the central volume of the macula are the primary goals and the evaluation of the best visual acuity of the patient is the secondary goal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case: Intravitreal injection of bevacizumab with oral curcumin | Experimental | Drug: bevacizumab with oral curcuminIntravitreal injection of bevacizumab with oral curcumin Inclusion criteria: Patients with center-involving macular edema with macular center thickness of more than 300 microns in OCT 2-Patients who did not receive intravitreal bevacizumab in the last 3 months and intravitreal corticosteroids in the previous 6 months. 3- The amount of BCVA should not be <20/400. 4-Consent to participate in the study |
| Control: Intravitreal injection of bevacizumab with oral placebo | Placebo comparator | Drug: bevacizumab with oral placeboIntravitreal injection of bevacizumab with oral placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with center-involving macular edema with macular center thickness more than 300 microns in OCT 2-Patients who did not receive intravitreal bevacizumab in the last 3 months and intravitreal corticosteroids in the last 6 months.
- 3- The amount of BCVA should not be <20/400. 4-Consent to participate in the study
Key exclusion criteria (12 listed)
- Other retinal diseases except for DME and macular edema due to other causes including uveitis, epiretinal membrane, central retinal vein occlusion, and...
- Existence of proliferative diabetic retinopathy and patients with a history of vitrectomy
- Patients with glaucoma, vitreous hemorrhage, age-related macular degeneration (ARMD)
- Media opacities that limit the interpretation of diagnostic tests
- Surgery or procedure 3 months before starting treatment
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 with oral curcuminAlso: intervention groupAccording to the recommendation of the American Association of Ophthalmologists, intravitreal injection of bevacizumab with a standard dose of 1.25mg/0.05ml in each group will be performed three times consecutively at one-month intervals. In the simultaneous intervention group, patients will take daily curcumin tablets (sinacurcumin product) at a dose of 40 mg twice a day for three months (at the same time as the start of bevacizumab intravitreal injection treatment). | Drug | Case: Intravitreal injection of bevacizumab with oral curcumin |
| bevacizumab with oral placeboAlso: placeboIntravitreal injection of bevacizumab with a standard dose of 1.25mg/0.05ml in each group will be performed three times consecutively at one-month intervals. In the control group, patients will be taking daily placebo tablets twice a day for three months (at the same time as the start of bevacizumab intravitreal injection treatment). | Drug | Control: Intravitreal injection of bevacizumab with oral placebo |
Primary outcome
central macular thickness (CMT)
Time frame: 3 months
Changes in central macular thickness (CMT) in patients with oral Curcumin versus patients in the control group
central macular volume (CMV)
Time frame: 3 months
Changes in central macular volume (CMV) in patients with oral Curcumin versus patients in the control group
1 secondary outcome
best visual acuity (BCVA)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Diabetic Macular Edema
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingPhase 3
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
Diabetic Macular Edema, DME
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 with oral curcumin in people with Diabetic Macular Edema and Macular Edema, run by Isfahan 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 2 inclusion and 12 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 19 Sep 2024. 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 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
central macular thickness (CMT) (time frame: 3 months). 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 19 Sep 2024.