Comparison of Combined Intravitreal Bevacizumab and Oral Acetazolamide Versus Intravitreal Bevacizumab Alone for the Treatment of Macular Edema Secondary to Retinal Vein Occlusions
- Sponsor
- Shahid Beheshti University of Medical Sciences
- Study ID
- NCT05290948
- Phase
- PHASE2
- Status
- Unknown
Conditions
- Macular Edema
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- intravitreal injection of bevacizumab with acetazolamide tablets — DRUGintravitreal injection of bevacizumab with acetazolamide tablets
- intravitreal injection of bevacizumab — DRUGintravitreal injection of bevacizumab
Study Details
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.
Key Dates
- First listed
- Mar 22, 2022
- Start date
- Mar 12, 2022
- Status verified
- Mar 2022
- Primary completion
- Jul 1, 2022
- Completion
- Dec 1, 2022
Study Design
- Enrollment
- 57 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: investigate of the effect of intravitreal injection of bevacizumab with acetazolamide tablets
- Active Comparator: Investigate the effect of intravitreal injection of bevacizumab alone
Primary Outcome Measure
Best Corrected Visual Acuity [ Time Frame: 3 months ]
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