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 (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05290948
• Collaborator: (none)
• Enrollment: 57
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 8.7
• Patients Per Site Per Month: 6.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Macular Edema	Drug: intravitreal injection of bevacizumab with acetazolamide tablets; Drug: intravitreal injection of bevacizumab	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 57 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Mar 12, 2022
• Anticipated Primary Completion Date: Jul 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: investigate of the effect of intravitreal injection of bevacizumab with acetazolamide tablets	Drug: intravitreal injection of bevacizumab with acetazolamide tablets; intravitreal injection of bevacizumab with acetazolamide tablets
Active Comparator: Investigate the effect of intravitreal injection of bevacizumab alone	Drug: intravitreal injection of bevacizumab; intravitreal injection of bevacizumab

Outcome Measures

Primary Outcome Measures

1. Best Corrected Visual Acuity [3 months]

   the best corrective vision correction that achieved by glasses, as measured on the standard Snellen eye chart

Secondary Outcome Measures

1. Central macular thickness [3 months]

   Thickness measurements by spectral-domain optical coherence tomography systems (SD-OCT)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ophthalmic Research center	Tehran		Iran, Islamic Republic of	1659756151

Sponsors and Collaborators

• Shahid Beheshti University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zahra Rabbani Khah, Head of Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences
• ClinicalTrials.gov Identifier: NCT05290948
• Other Study ID Numbers: 14003
• First Posted: Mar 22, 2022
• Last Update Posted: Mar 22, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Macular Edema; Retinal Vein Occlusion; Edema; Bevacizumab; Acetazolamide

Study Results

No Results Posted as of Mar 22, 2022