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

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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