Back to resultsComparison of Combined Intravitreal Bevacizumab and Oral Acetazolamide Versus Intravitreal Bevacizumab Alone for the Treatment of Macular Edema Secondary to Retinal Vein Occlusions
Primary Purpose
Macular Edema
Status
Active
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
intravitreal injection of bevacizumab with acetazolamide tablets
intravitreal injection of bevacizumab
Sponsored by
About this trial
This is an interventional treatment trial for Macular Edema
Eligibility Criteria
Inclusion Criteria:
- 20 / 400≤ Best Corrected Visual Acuity ≤20 / 40
- Central macular thickness <300 μm
- The onset of the disease is less than three years
- No other eye diseases that affect the evaluation and process of this study.
Exclusion Criteria:
- It is not possible to provide informed consent.
- Patients who are prohibited from taking oral acetazolamide (renal failure, hepatic failure, history of allergies)
- Other eye diseases that affect the evaluation and process of this study. Including diabetes retinopathy
- History of retinal laser photocoagulation
Sites / Locations
- Ophthalmic Research center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
investigate of the effect of intravitreal injection of bevacizumab with acetazolamide tablets
Investigate the effect of intravitreal injection of bevacizumab alone
Arm Description
Outcomes
Primary Outcome Measures
Best Corrected Visual Acuity
the best corrective vision correction that achieved by glasses, as measured on the standard Snellen eye chart
Secondary Outcome Measures
Central macular thickness
Thickness measurements by spectral-domain optical coherence tomography systems (SD-OCT)
Full Information
NCT ID
NCT05290948
First Posted
March 12, 2022
Last Updated
March 12, 2022
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05290948
Brief Title
Comparison of Combined Intravitreal Bevacizumab and Oral Acetazolamide Versus Intravitreal Bevacizumab Alone for the Treatment of Macular Edema Secondary to Retinal Vein Occlusions
Official Title
Comparison of Combined Intravitreal Bevacizumab and Oral Acetazolamide Versus Intravitreal Bevacizumab Alone for the Treatment of Macular Edema Secondary to Retinal Vein Occlusions
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 12, 2022 (Actual)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
In this study, which will be performed as a randomized clinical trial, all patients with macular edema with central involvement (central macular thickness greater than 300 μm) and corrected vision less than or equal to 20/40 and better than 20/400 were included in the study. After a thorough eye examination, people are randomly divided into two groups. The first group was treated with intravitreal injection of Bevacizumab in three injections one month apart with receiving oral Acetazolamide tablets of 250 mg twice a day, and the second group was treated with intravitreal injection of Bevacizumab for three Loads are spaced one month apart. Ophthalmologic examinations and corrected visual acuity, as well as macular thickness examination, are repeated with Spectral-domain Optical coherence tomography (SD-OCT) at the beginning of treatment and at the end of the first, second, and third months. At the end of the study, the rate of changes in visual acuity and macular thickness in the eyes in the two groups will be compared and will be statistically analyzed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
57 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
investigate of the effect of intravitreal injection of bevacizumab with acetazolamide tablets
Arm Type
Active Comparator
Arm Title
Investigate the effect of intravitreal injection of bevacizumab alone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
intravitreal injection of bevacizumab with acetazolamide tablets
Intervention Description
intravitreal injection of bevacizumab with acetazolamide tablets
Intervention Type
Drug
Intervention Name(s)
intravitreal injection of bevacizumab
Intervention Description
intravitreal injection of bevacizumab
Primary Outcome Measure Information:
Title
Best Corrected Visual Acuity
Description
the best corrective vision correction that achieved by glasses, as measured on the standard Snellen eye chart
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Central macular thickness
Description
Thickness measurements by spectral-domain optical coherence tomography systems (SD-OCT)
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
20 / 400≤ Best Corrected Visual Acuity ≤20 / 40
Central macular thickness <300 μm
The onset of the disease is less than three years
No other eye diseases that affect the evaluation and process of this study.
Exclusion Criteria:
It is not possible to provide informed consent.
Patients who are prohibited from taking oral acetazolamide (renal failure, hepatic failure, history of allergies)
Other eye diseases that affect the evaluation and process of this study. Including diabetes retinopathy
History of retinal laser photocoagulation
Facility Information:
Facility Name
Ophthalmic Research center
City
Tehran
ZIP/Postal Code
1659756151
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Comparison of Combined Intravitreal Bevacizumab and Oral Acetazolamide Versus Intravitreal Bevacizumab Alone for the Treatment of Macular Edema Secondary to Retinal Vein Occlusions
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