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

NCT05290948 | Unknown Phase 2

• 1 other identifier: 14003
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Macular Edema

Outcome Measures

Primary Outcomes (1)

• Best Corrected Visual Acuity

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

  3 months

Secondary Outcomes (1)

• Central macular thickness

  3 months

Study Arms (2)

investigate of the effect of intravitreal injection of bevacizumab with acetazolamide tablets

ACTIVE COMPARATOR

Drug: intravitreal injection of bevacizumab with acetazolamide tablets

Investigate the effect of intravitreal injection of bevacizumab alone

ACTIVE COMPARATOR

Drug: intravitreal injection of bevacizumab

Interventions

intravitreal injection of bevacizumab with acetazolamide tablets DRUG

intravitreal injection of bevacizumab with acetazolamide tablets

investigate of the effect of intravitreal injection of bevacizumab with acetazolamide tablets

intravitreal injection of bevacizumab DRUG

intravitreal injection of bevacizumab

Investigate the effect of intravitreal injection of bevacizumab alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• / 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Ophthalmic Research center

Tehran, 1659756151, Iran

Location

Related Publications (1)

• Karimi S, Nikkhah H, Nafisi H, Nouri H, Ansari I, Barkhordari S, Samnejad S, Abtahi SH. Acetazolamide and bevacizumab combination therapy versus bevacizumab monotherapy in macular edema secondary to retinal vein occlusion. J Fr Ophtalmol. 2023 Apr;46(4):322-326. doi: 10.1016/j.jfo.2022.09.025. Epub 2023 Feb 2.

  PMID: 36739258 DERIVED

MeSH Terms

Conditions

Macular Edema

Interventions

Acetazolamide

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Thiadiazoles; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Ophthalmic Research Center

Study Record Dates

• First Submitted: March 12, 2022
• First Posted: March 22, 2022
• Study Start: March 12, 2022
• Primary Completion: July 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 22, 2022

Record last verified: 2022-03

Locations

IR (1)