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

NCT ID: NCT05290948

Last Updated: 2022-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-12

Study Completion Date

2022-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Macular Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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

Group Type ACTIVE_COMPARATOR

intravitreal injection of bevacizumab with acetazolamide tablets

Intervention Type DRUG

intravitreal injection of bevacizumab with acetazolamide tablets

Investigate the effect of intravitreal injection of bevacizumab alone

Group Type ACTIVE_COMPARATOR

intravitreal injection of bevacizumab

Intervention Type DRUG

intravitreal injection of bevacizumab

Interventions

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intravitreal injection of bevacizumab with acetazolamide tablets

intravitreal injection of bevacizumab with acetazolamide tablets

Intervention Type DRUG

intravitreal injection of bevacizumab

intravitreal injection of bevacizumab

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Zahra Rabbani Khah

Head of Ophthalmic Research Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ophthalmic Research center

Tehran, , Iran

Site Status

Countries

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Iran

References

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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.

Reference Type DERIVED
PMID: 36739258 (View on PubMed)

Other Identifiers

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14003

Identifier Type: -

Identifier Source: org_study_id

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