- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05582577
Additional Effect of Subthreshold Micropulse Laser to Intravitreous Injection of Bevacizumab on Diabetic Macular Edema
Additional Effect of Sub-threshold Micro-pulse Laser to Intra-vitreous Injection of Bevacizumab on Diabetic Macular Edema: A Randomized Double-blinded Clinical Trial
In this study, all eyes with diabetic macular edema who meet the inclusion criteria and do not meet the exclusion criteria will be included. After the eye examination, the eyes will be randomly divided into 2 groups {group A: intravitreal interjection of Bevacizumab and subthreshold micropulse laser, and group B: intravitreal injection of Bevacizumab alone}. For both groups, 3 intravitreal injections of bevacizumab with a dose of 1.25 mg will be performed, in sterile conditions at 1-month intervals as a loading dose.
A subthreshold micropulse laser will be performed after the third injection in group A and a sham laser will be performed after the third injection in group B. Then, the intravitreal injection of Bevacizumab will be continued if the central thickness of the macula is equal to or greater than 300 microns.
The follow-up will be performed 2, 3, 4, 6, 8, 10, and 12 months after the first injection. In each follow-up (except for the first month), ophthalmological examinations and Optical Coherence Tomography will be performed.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Tehran, Iran, Islamic Republic of
- Ophthalmic Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- > 18 years diabetic patients
- Center-involved diabetic macular edema
- Mean central subfield thickness >300 micrometers
- Best-corrected visual acuity between 20/40 and 20/400
Exclusion Criteria:
- hemoglobin A1c > 8
- High-risk proliferative diabetic retinopathy
- Prior treatment with intravitreal or peribulbar injections within the preceding 3 months
- History of panretinal photocoagulation within the former 4 months
- History of macular photocoagulation
- Hx of Intraocular surgery (except cataract extraction)
- cataract extraction less than 6 months ago
- Macular edema due to a cause other than diabetic retinopathy
- Any other ocular condition that visual acuity would not improve from the resolution of the edema (eg, foveal atrophy)
- Substantial cataract estimated to have reduced visual acuity by >3 lines
- uveitis, neovascular glaucoma, exudative age-related macular degeneration, high risk proliferative diabetic retinopathy
- vitreomacular traction or epiretinal membrane
- uncontrolled glaucoma ( > 30 millimeters of mercury with anti-glaucoma medications)
- Not having: Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Simultaneous intravitreal bevacizumab injection with subthreshold micropulse laser
After the eye examination, the eyes will be randomly divided into 2 groups {group A: intravitreal interjection of Bevacizumab and subthreshold micropulse laser, and group B: intravitreal injection of Bevacizumab alone}. For both groups, 3 intravitreal injections of bevacizumab with a dose of 1.25 mg will be performed, in sterile conditions at 1-month intervals as a loading dose. A subthreshold micropulse laser will be performed after the third injection in group A. Then, the intravitreal injection of Bevacizumab will be continued if the central thickness of the macula is equal to or greater than 300 microns. The follow-up will be performed 2, 3, 4, 6, 8, 10, and 12 months after the first injection. In each follow-up (except for the first month), ophthalmological examinations and Optical Coherence Tomography will be performed. |
Group A: intravitreal interjection of Bevacizumab and subthreshold micropulse laser
|
Active Comparator: Intravitreal bevacizumab injection alone
After the eye examination, the eyes will be randomly divided into 2 groups {group A: intravitreal interjection of Bevacizumab and subthreshold micropulse laser, and group B: intravitreal injection of Bevacizumab alone}. For both groups, 3 intravitreal injections of bevacizumab with a dose of 1.25 mg will be performed, in sterile conditions at 1-month intervals as a loading dose. A sham laser will be performed after the third injection in group B. Then, the intravitreal injection of Bevacizumab will be continued if the central thickness of the macula is equal to or greater than 300 microns. The follow-up will be performed 2, 3, 4, 6, 8, 10, and 12 months after the first injection. In each follow-up (except for the first month), ophthalmological examinations and Optical Coherence Tomography will be performed. |
Group B: Intravitreal injection of Bevacizumab alone
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline central macular thickness at 2 months
Time Frame: Change from baseline to 2 months
|
Change from baseline central macular thickness at 2 months using Optical Coherence Tomography
|
Change from baseline to 2 months
|
Change from 2 months central macular thickness at 3 months
Time Frame: Change from 2 months to 3 months
|
Change from 2 months central macular thickness at 3 months using Optical Coherence Tomography
|
Change from 2 months to 3 months
|
Change from 3 months central macular thickness at 4 months
Time Frame: Change from 3 months to 4 months
|
Change from 3 months central macular thickness at 4 months using Optical Coherence Tomography
|
Change from 3 months to 4 months
|
Change from 4 months central macular thickness at 6 months
Time Frame: Change from 4 months to 6 months
|
Change from 4 months central macular thickness at 6 months using Optical Coherence Tomography
|
Change from 4 months to 6 months
|
Change from 6 months central macular thickness at 8 months
Time Frame: Change from 6 months to 8 months
|
Change from 6 months central macular thickness at 8 months using Optical Coherence Tomography
|
Change from 6 months to 8 months
|
Change from 8 months central macular thickness at 10 months
Time Frame: Change from 8 months to 10 months
|
Change from 8 months central macular thickness at 10 months using Optical Coherence Tomography
|
Change from 8 months to 10 months
|
Change from 10 months central macular thickness at 12 months
Time Frame: Change from 10 months to 12 months
|
Change from 10 months central macular thickness at 12 months using Optical Coherence Tomography
|
Change from 10 months to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline visual acuity at 2 months
Time Frame: Change from baseline to 2 months
|
Change from baseline best-corrected visual acuity at 2 months
|
Change from baseline to 2 months
|
Change from 2 months visual acuity at 3 months
Time Frame: Change from 2 months to 3 months
|
Change from 2 months best-corrected visual acuity at 3 months
|
Change from 2 months to 3 months
|
Change from 3 months visual acuity at 4 months
Time Frame: Change from 3 months to 4 months
|
Change from 3 months best-corrected visual acuity at 4 months
|
Change from 3 months to 4 months
|
Change from 4 months visual acuity at 6 months
Time Frame: Change from 4 months to 6 months
|
Change from 4 months best-corrected visual acuity at 6 months
|
Change from 4 months to 6 months
|
Change from 6 months visual acuity at 8 months
Time Frame: Change from 6 months to 8 months
|
Change from 6 months best-corrected visual acuity at 8 month
|
Change from 6 months to 8 months
|
Change from 8 months visual acuity at 10 months
Time Frame: Change from 8 months to 10 months
|
Change from 8 months best-corrected visual acuity at 10 months
|
Change from 8 months to 10 months
|
Change from 10 months visual acuity at 12 months
Time Frame: Change from 10 months to 12 months
|
Change from 10 months best-corrected visual acuity at 12 months
|
Change from 10 months to 12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Alireza Ramezani, Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14016 (company internal)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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