Macular EdemaPhase 2NCT05290948
Comparison of Combined Intravitreal Bevacizumab and Oral Acetazolamide Versus Intravitreal Bevacizumab Alone for the Treatment of Macular Edema Secondary to Retinal Vein Occlusions
A Phase 2 study testing intravitreal injection of bevacizumab with acetazolamide tablets and intravitreal injection of bevacizumab in people with Macular Edema, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Macular Edema
- What is being tested?
- intravitreal injection of bevacizumab with acetazolamide tablets and intravitreal injection of bevacizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteIran
- Study dates
- 12 Mar 2022to 1 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- intravitreal injection of bevacizumab with acetazolamide tablets, intravitreal injection of bevacizumab
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravitreal injection of bevacizumab with acetazolamide tabletsDrug
intravitreal injection of bevacizumab with acetazolamide tablets
intravitreal injection of bevacizumabDrug
intravitreal injection of bevacizumab
| Study group | Role | What they receive |
|---|---|---|
| investigate of the effect of intravitreal injection of bevacizumab with acetazolamide tablets | Active comparator | Not described Receives: Drug: intravitreal injection of bevacizumab with acetazolamide tablets |
| Investigate the effect of intravitreal injection of bevacizumab alone | Active comparator | Not described Receives: Drug: intravitreal injection of bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Visual Acuity
the best corrective vision correction that achieved by glasses, as measured on the standard Snellen eye chart
Measured: 3 months
Secondary outcomes (1)
Central macular thickness
Thickness measurements by spectral-domain optical coherence tomography systems (SD-OCT)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start12 Mar 2022
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05290948
- Sponsor's protocol ID
- 14003
- Status last verified
- Mar 2022
- First submitted
- 12 Mar 2022
- Last updated
- 22 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36739258
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05290948
- Acronym / sponsor ID
- 14003
- Conditions
- Macular Edema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 12 Mar 2022 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 22 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravitreal injection of bevacizumab with acetazolamide tabletsintravitreal injection of bevacizumab with acetazolamide tablets | Drug | investigate of the effect of intravitreal injection of bevacizumab with acetazolamide tablets |
| intravitreal injection of bevacizumabintravitreal injection of bevacizumab | Drug | Investigate the effect of intravitreal injection of bevacizumab alone |
Primary outcome
Best Corrected Visual Acuity
Time frame: 3 months
the best corrective vision correction that achieved by glasses, as measured on the standard Snellen eye chart
1 secondary outcome
Central macular thickness
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Derived from this study: PubMed 36739258Karimi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing intravitreal injection of bevacizumab with acetazolamide tablets and intravitreal injection of bevacizumab in people with Macular Edema, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Corrected Visual Acuity (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05290948, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.