Comparison of Combined Intravitreal Bevacizumab and Oral Acetazolamide Versus Intravitreal Bevacizumab Alone for the Treatment of Macular Edema Secondary to Retinal Vein Occlusions

Macular Edema Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05290948
• Other study ID #: 14003
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 12, 2022
• Est. completion date: December 1, 2022

Study information

• Verified date: March 2022
• Source: Shahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 57
• Est. completion date: December 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Edema
• Macular Edema
• Retinal Vein Occlusion

Intervention

Drug:
• intravitreal injection of bevacizumab with acetazolamide tablets
intravitreal injection of bevacizumab with acetazolamide tablets
• intravitreal injection of bevacizumab
intravitreal injection of bevacizumab

Locations

Country	Name	City	State
Iran, Islamic Republic of	Ophthalmic Research center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Corrected Visual Acuity	the best corrective vision correction that achieved by glasses, as measured on the standard Snellen eye chart	3 months
Secondary	Central macular thickness	Thickness measurements by spectral-domain optical coherence tomography systems (SD-OCT)	3 months