Neovascular GlaucomaNCT05316142
Effect of Subconjunctival 5-fluorouracil on the Outcome of Ahmed Valve in Neovascular Glaucoma
A study testing AGV with intraoperation MMC and postoperative BSS and AGV with intraoperation MMC and post operation 5FU in people with Neovascular Glaucoma, run by Iran University of Medical Sciences at 1 site in Iran.
Trial summary
Neovascular glaucoma is a common and severe type of secondary closed-angle glaucoma. Topical treatments have variable effects and unfortunately often require surgery to control IOP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neovascular Glaucoma
- What is being tested?
- AGV with intraoperation MMC and postoperative BSS and AGV with intraoperation MMC and post operation 5FU
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIran
- Study dates
- 1 May 2024to 1 Dec 2025
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with diagnosis of neovascular glaucoma
Who cannot join
- Patients with no light perception
- Patients aged less than 18 years old
- History of previous GDD implantation
- History of cyclodestructive procedures
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Subconjunctival 5-fluorouracil on the Outcome of Ahmed Valve in Neovascular Glaucoma: Randomized Clinical Trial
Neovascular glaucoma is a common and severe type of secondary closed-angle glaucoma. Topical treatments have variable effects and unfortunately often require surgery to control IOP. Although Glaucoma Drainage Device (GDD) such as Ahmed Glaucoma Valve (AGV) are a surgical choice in these patients, their effectiveness decreases over time.
One of the main causes of failure in AGV surgery is the formation of scar tissue and fibrosis around the shunt plate.
So, the aim of this study was to evaluate the effect of using MMC Intraoperative and 5FU Postoperative with AGV surgery in neovascular glaucoma patients according to a specific protocol, on the incidence of Hypertensive Phase (HP) and surgical success rate.
Read the detailed description
All patients with neovascular glaucoma who need surgery for the first time are included in the study. Inclusion criteria include patients over 18 years of age with neovascular glaucoma whose IOP is not controlled by medical treatment. Exclusion criteria Study includes: No Light Perception patients, age less than 18 years, history of any type of eye surgery including previous glaucoma and retinal surgeries (except uncomplicated cataract surgery), history of cyclodestructive procedures, pregnant patients.
Patients after obtaining a history, especially of drugs and underlying diseases, under complete ophthalmic examination including: visual acuity (VA) and BCVA with Snelln chart, examination with slit lamp and performing dynamic gonioscopy using, IOP measurement with Goldmann Applanation Tonometer and corneal thickness measurement (CCT). . Patients are then randomized using permuted block design computer and placed in two groups of AGV surgery with anti-fibrotic treatment and AGV surgery alone.
In AGV surgery, the conjunctiva of the superotemporal area is first dissected. The plate shunt is then threaded 10 mm from the limbus to the sclera with non-absorbable proline thread. The tube insertion is then performed using a 23g needle, and after fixing the scleral patch, the conjugate is threaded with 8.0 vicryl thread and the shunt surgery is completed.
In all patients during surgery and before fixing the shunt plate, MMC is used with a sponge at a dose of 0.2 mg / ml for 2 minutes and then washed with a large amount of BSS. All patients receive intraviteral bevacizumab at the end of the operation. In the postoperative anti-fibrotic group during F/U in the first, third and fifth weeks, 5FU subconjunctival injection is performed after local anesthesia with tetracaine behind the slit lamp for all patients with a pressure above 6 mm Hg. 5FU with a volume of 0.1 ml containing 5 mg of drug is injected in the area of the tendon adjacent to the shunt plate.
After surgery, patients undergo regular examinations. Patients at least on the first day, first week, third week, fifth week, third month, sixth month, twelfth month in terms of visual acuity, refraction, IOP, various surgical complications, the number of drugs used to control IOP are evaluated.
- Conditions
- Neovascular Glaucoma
- Being tested
- AGV with intraoperation MMC and postoperative BSS, AGV with intraoperation MMC and post operation 5FU
- Keywords
- Neovascular Glaucoma (NVG), Ahmed Glaucoma Valve (AGV), 5FU, MMC
- Medical subject headings
- Glaucoma, Neovascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGV with intraoperation MMC and postoperative BSSProcedure or surgery
This method will use Ahmad FP7 model valved shunt (New World Medical, LA), which is one of the most commonly used shunts in the world
AGV with intraoperation MMC and post operation 5FUProcedure or surgery
This method will use Ahmad FP7 model valve shunt (New World Medical, LA). First, 5FU at a dose of 0.04% is placed in the shunt plate for two minutes and then rinsed.
| Study group | Role | What they receive |
|---|---|---|
| AGV with intraoperation MMC and postoperative BSS | Active comparator | Patients with neovascular glaucoma undergoing shunt implant surgery with MMC during surgery. This method will use Ahmad FP7 model valved shunt (New World Medical, LA), which is one of the most commonly used shunts in the world. First, MMC at a dose of 0.04% is placed in the shunt plate for two minutes and then rinsed. The shunt is fixed and then the shunt tube is inserted into the eye and fixed with nylon 10.0 thread. The conjunctiva is also swabbed with 8.0 vicryl sutures. After the operation, patients undergo regular examinations according to a specific protocol to evaluate the effectiveness as well as possible complications.
Also in the first, third and fifth weeks, BSS injections are given as a subconjugate with a volume of 0.1 ml. Receives: Procedure: AGV with intraoperation MMC and postoperative BSS |
| AGV with intraoperation MMC and postoperation 5FU | Active comparator | Patients with neovascular glaucoma undergoing shunt implant surgery with MMC during and 5FU after surgery .This method will use Ahmad FP7 model valved shunt (New World Medical, LA), which is one of the most commonly used shunts in the world. First, 5FU at a dose of 0.04% is placed in the shunt plate for two minutes and then rinsed. The shunt is fixed and then the shunt tube is inserted into the eye and fixed with nylon 10.0 thread. The conjunctiva is also swabbed with 8.0 vicryl sutures. After the operation, patients undergo regular examinations according to a specific protocol to evaluate the effectiveness as well as possible complications. Also in the first, third and fifth weeks, 5FU injections are given as a subconjugate with a volume of 0.1 ml containing 5 mg of the drug. Receives: Procedure: AGV with intraoperation MMC and post operation 5FU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate (SR)
- Reduction of at least 20% IOP after surgery 2. 21> IOP> 6 with or without medication
Measured: Sixth month
Hypertensive Phase (HP)
IOP>21 after surgery
Measured: Third month
Secondary outcomes (1)
Number of mediaction
Number of antiglauocoma medication after surgery
Measured: Sixth month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start1 May 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular GlaucomaStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical trial study with two parallel groups, randomized using computer permuted block randomization, 35 patients in each group are included and followed up for at least 6 months.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05316142
- Sponsor's protocol ID
- 1400-2-86-21845
- Status last verified
- Sep 2024
- First submitted
- 30 Mar 2022
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Subconjunctival 5-fluorouracil on the Outcome of Ahmed Valve in Neovascular Glaucoma: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05316142
- Acronym / sponsor ID
- 1400-2-86-21845
- Conditions
- Neovascular Glaucoma
- Keywords
- Neovascular Glaucoma (NVG), Ahmed Glaucoma Valve (AGV), 5FU, MMC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Iran University of Medical SciencesUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 7 Apr 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.
Neovascular glaucoma is a common and severe type of secondary closed-angle glaucoma. Topical treatments have variable effects and unfortunately often require surgery to control IOP. Although Glaucoma Drainage Device (GDD) such as Ahmed Glaucoma Valve (AGV) are a surgical choice in these patients, their effectiveness decreases over time.
One of the main causes of failure in AGV surgery is the formation of scar tissue and fibrosis around the shunt plate.
So, the aim of this study was to evaluate the effect of using MMC Intraoperative and 5FU Postoperative with AGV surgery in neovascular glaucoma patients according to a specific protocol, on the incidence of Hypertensive Phase (HP) and surgical success rate.
Detailed description
All patients with neovascular glaucoma who need surgery for the first time are included in the study. Inclusion criteria include patients over 18 years of age with neovascular glaucoma whose IOP is not controlled by medical treatment. Exclusion criteria Study includes: No Light Perception patients, age less than 18 years, history of any type of eye surgery including previous glaucoma and retinal surgeries (except uncomplicated cataract surgery), history of cyclodestructive procedures, pregnant patients.
Patients after obtaining a history, especially of drugs and underlying diseases, under complete ophthalmic examination including: visual acuity (VA) and BCVA with Snelln chart, examination with slit lamp and performing dynamic gonioscopy using, IOP measurement with Goldmann Applanation Tonometer and corneal thickness measurement (CCT). . Patients are then randomized using permuted block design computer and placed in two groups of AGV surgery with anti-fibrotic treatment and AGV surgery alone.
In AGV surgery, the conjunctiva of the superotemporal area is first dissected. The plate shunt is then threaded 10 mm from the limbus to the sclera with non-absorbable proline thread. The tube insertion is then performed using a 23g needle, and after fixing the scleral patch, the conjugate is threaded with 8.0 vicryl thread and the shunt surgery is completed.
In all patients during surgery and before fixing the shunt plate, MMC is used with a sponge at a dose of 0.2 mg / ml for 2 minutes and then washed with a large amount of BSS. All patients receive intraviteral bevacizumab at the end of the operation. In the postoperative anti-fibrotic group during F/U in the first, third and fifth weeks, 5FU subconjunctival injection is performed after local anesthesia with tetracaine behind the slit lamp for all patients with a pressure above 6 mm Hg. 5FU with a volume of 0.1 ml containing 5 mg of drug is injected in the area of the tendon adjacent to the shunt plate.
After surgery, patients undergo regular examinations. Patients at least on the first day, first week, third week, fifth week, third month, sixth month, twelfth month in terms of visual acuity, refraction, IOP, various surgical complications, the number of drugs used to control IOP are evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Clinical trial study with two parallel groups, randomized using computer permuted block randomization, 35 patients in each group are included and followed up for at least 6 months.
| Arm | Type | Receives |
|---|---|---|
| AGV with intraoperation MMC and postoperative BSS | Active comparator | Procedure: AGV with intraoperation MMC and postoperative BSSPatients with neovascular glaucoma undergoing shunt implant surgery with MMC during surgery. This method will use Ahmad FP7 model valved shunt (New World Medical, LA), which is one of the most commonly used shunts in the world. First, MMC at a dose of 0.04% is placed in the shunt plate for two minutes and then rinsed. The shunt is fixed and then the shunt tube is inserted into the eye and fixed with nylon 10.0 thread. The conjunctiva is also swabbed with 8.0 vicryl sutures. After the operation, patients undergo regular examinations according to a specific protocol to evaluate the effectiveness as well as possible complications. Also in the first, third and fifth weeks, BSS injections are given as a subconjugate with a volume of 0.1 ml. |
| AGV with intraoperation MMC and postoperation 5FU | Active comparator | Procedure: AGV with intraoperation MMC and post operation 5FUPatients with neovascular glaucoma undergoing shunt implant surgery with MMC during and 5FU after surgery .This method will use Ahmad FP7 model valved shunt (New World Medical, LA), which is one of the most commonly used shunts in the world. First, 5FU at a dose of 0.04% is placed in the shunt plate for two minutes and then rinsed. The shunt is fixed and then the shunt tube is inserted into the eye and fixed with nylon 10.0 thread. The conjunctiva is also swabbed with 8.0 vicryl sutures. After the operation, patients undergo regular examinations according to a specific protocol to evaluate the effectiveness as well as possible complications. Also in the first, third and fifth weeks, 5FU injections are given as a subconjugate with a volume of 0.1 ml containing 5 mg of the drug. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with diagnosis of neovascular glaucoma
Key exclusion criteria (5 listed)
- Patients with no light perception
- Patients aged less than 18 years old
- History of previous GDD implantation
- History of cyclodestructive procedures
- Pregnant patients
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 with intraoperation MMC and postoperative BSSThis method will use Ahmad FP7 model valved shunt (New World Medical, LA), which is one of the most commonly used shunts in the world | Procedure or surgery | AGV with intraoperation MMC and postoperative BSS |
| AGV with intraoperation MMC and post operation 5FUThis method will use Ahmad FP7 model valve shunt (New World Medical, LA). First, 5FU at a dose of 0.04% is placed in the shunt plate for two minutes and then rinsed. | Procedure or surgery | AGV with intraoperation MMC and postoperation 5FU |
Primary outcome
Success Rate (SR)
Time frame: Sixth month
1. Reduction of at least 20% IOP after surgery 2. 21> IOP> 6 with or without medication
Hypertensive Phase (HP)
Time frame: Third month
IOP>21 after surgery
1 secondary outcome
Number of mediaction
Time frame: Sixth month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 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 study testing AGV with intraoperation MMC and postoperative BSS and AGV with intraoperation MMC and post operation 5FU in people with Neovascular Glaucoma, run by Iran 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 1 inclusion and 5 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 6 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 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.
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?
Success Rate (SR) (time frame: Sixth month). The study lists 2 primary outcomes in all. 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 6 May 2025.