Health TrialsbyHealthPanel

Efficacy and Safety of Intravitreal Injection of Bevacizumab with and Without Oral Curcumin

ConditionsDiabetic Macular EdemaMacular EdemaRetinal Neovascularization
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age40+
SponsorIsfahan University of Medical Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • bevacizumab with oral curcumin

    Drug

    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 placebo

    Drug

    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).

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: Case: Intravitreal injection of bevacizumab with oral curcuminExperimental treatment 1 intervention
Group B: Control: Intravitreal injection of bevacizumab with oral placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

central macular thickness (CMT)

Changes in central macular thickness (CMT) in patients with oral Curcumin versus patients in the control group

Time frame
3 months
2

central macular volume (CMV)

Changes in central macular volume (CMV) in patients with oral Curcumin versus patients in the control group

Time frame
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

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Isfahan University of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov
Apply now