Pediatric GlaucomaEarly Phase 1MMC glaucomaNCT06983704
Assessing Combined Bevacizumab-Mitomycin C Use During Ahmed Valve Revision in Recurrent Pediatric Glaucoma
A Early Phase 1 study testing AGV plate and bevacizumab injection in people with Pediatric Glaucoma, run by Benha University at 1 site in Egypt.
Trial summary
To asess the efficacy and safety of combining subconjunctival bevacizumab with mitomycin C (MMC) during AGV revision surgery in pediatric patients with recurrent glaucoma. Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Pediatric Glaucoma
- What is being tested?
- AGV plate and bevacizumab injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Feb 2024to 15 Feb 2025
- Phase
- Early Phase 1
- 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 Up to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children under 12 years with previous AGV implantation for primary congenital glaucoma
Who cannot join
- age >12 years, eyes with no light perception, and those with prior cyclodestructive procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Combined Bevacizumab-Mitomycin C Use During Ahmed Valve Revision in Recurrent Pediatric Glaucoma
To asess the efficacy and safety of combining subconjunctival bevacizumab with mitomycin C (MMC) during AGV revision surgery in pediatric patients with recurrent glaucoma.
Read the detailed description
Recurrent pediatric glaucoma following Ahmed Glaucoma Valve (AGV) implantation presents a therapeutic challenge. This study evaluates the efficacy and safety of combining subconjunctival bevacizumab with mitomycin C (MMC) during AGV revision surgery in pediatric patients with recurrent glaucoma.
- Conditions
- Pediatric Glaucoma
- Being tested
- AGV plate, bevacizumab injection
- Keywords
- Pediatric glaucoma, Ahmed valve, bevacizumab, mitomycin C
- Medical subject headings
- Hydrophthalmos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGV plateProcedure or surgery
AGV plate using a 27-gauge needle
bevacizumab injectionProcedure or surgery
subconjunctival injection of bevacizumab
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | subconjunctival injection of bevacizumab was administered around the AGV plate using a 27-gauge needle Receives: Procedure: AGV plate; Procedure: bevacizumab injection |
| Group II | Active comparator | AGV plate using a 27-gauge needle Receives: Procedure: AGV plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
surgical success
IOP ≤ 21 mmHg and ≥ 5 mmHg without medications
Measured: for 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start9 Feb 2024
- Primary completion8 Feb 2025
- Study completion15 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric GlaucomaStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Mohamed Elsayed Mohamed Saad, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983704
- Sponsor's protocol ID
- Bevacizumab-MMC
- Other IDs
- Benha University
- Acronym
- MMC glaucoma
- Status last verified
- Feb 2024
- First submitted
- 14 May 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Combined Bevacizumab-Mitomycin C Use During Ahmed Valve Revision in Recurrent Pediatric Glaucoma
- ClinicalTrials.gov ID
- NCT06983704
- Acronym / sponsor ID
- MMC glaucoma / Bevacizumab-MMC
- Conditions
- Pediatric Glaucoma
- Keywords
- Pediatric glaucoma, Ahmed valve, bevacizumab, mitomycin C
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 9 Feb 2024 (actual)
- Primary completion
- 8 Feb 2025 (actual)
- Study completion
- 15 Feb 2025 (actual)
- First posted
- 21 May 2025 (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.
To asess the efficacy and safety of combining subconjunctival bevacizumab with mitomycin C (MMC) during AGV revision surgery in pediatric patients with recurrent glaucoma.
Detailed description
Recurrent pediatric glaucoma following Ahmed Glaucoma Valve (AGV) implantation presents a therapeutic challenge. This study evaluates the efficacy and safety of combining subconjunctival bevacizumab with mitomycin C (MMC) during AGV revision surgery in pediatric patients with recurrent glaucoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Procedure: AGV plate, Procedure: bevacizumab injectionsubconjunctival injection of bevacizumab was administered around the AGV plate using a 27-gauge needle |
| Group II | Active comparator | Procedure: AGV plateAGV plate using a 27-gauge needle |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children under 12 years with previous AGV implantation for primary congenital glaucoma
Key exclusion criteria (1 listed)
- age >12 years, eyes with no light perception, and those with prior cyclodestructive procedures.
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 |
|---|---|---|
| AGV plateAGV plate using a 27-gauge needle | Procedure or surgery | Group I, Group II |
| bevacizumab injectionsubconjunctival injection of bevacizumab | Procedure or surgery | Group I |
Primary outcome
surgical success
Time frame: for 12 months
IOP ≤ 21 mmHg and ≥ 5 mmHg without medications
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
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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 Early Phase 1 study testing AGV plate and bevacizumab injection in people with Pediatric Glaucoma, run by Benha University at 1 site in Egypt.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 21 May 2025. 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 Egypt. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
surgical success (time frame: for 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 May 2025.