GlaucomaPhase 3NCT04735601
Ahmed Valve Implantation Coated With Poly Lactic -Co-glycolic Acid (PLGA) Saturated With Mitomycin-C in the Management of Adult Onset Glaucoma in Sturge Weber Syndrome
A Phase 3 study testing Ahmed Valve in people with Glaucoma, run by Sohag University at 1 site in Egypt.
Trial summary
Sturge weber's syndrome is an oculcutaneous syndrome, ocular manifestations may include heamangioma in the eye lids, choroidal heamangioma, or glaucoma, the glaucoma may present at infancy and may be due to resistance to aqueous outflow through trabecular meshwork(1), it may develop later and this is due to episcleral… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Ahmed Valve
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2021to 15 Dec 2022
- Phase
- Phase 3
- 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 suffered from adult onset Sturge Weber syndrome and subjected to Ahmed valve implantation.
Who cannot join
- other ocular pathology; choroidal heamangioma, cataract, exudative retinal detachment.
- Patients under 18 years old
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University
Sohag, 82524
Hany Mahmoud, 01024368111, drhanymahmoud@gmail.com
About this study
Sturge weber's syndrome is an oculcutaneous syndrome, ocular manifestations may include heamangioma in the eye lids, choroidal heamangioma, or glaucoma, the glaucoma may present at infancy and may be due to resistance to aqueous outflow through trabecular meshwork(1), it may develop later and this is due to episcleral venous raised pressure.(2-3) Glaucoma associated with Sturge weber syndrome is difficult to be treated medically with high risk of complications when treated with bleb -based surgeries. Suprachoroidal hemorrhage or detachment is a challenging complication which must be encountered.
The usage of Ahmed valve in the management of glaucoma associated with Sturge weber syndrome is a bleb based procedure carries the risks of over filtration or encapsulation and decreased filtration with failure to control glaucoma.
Read more
The use of Ahmed valve in the management of pediatric glaucoma associated with Sturge weber syndrome has better results as recorded by Nassiri et al. Ahmed valve implantation can have some drawbacks such as pupillary irregularity, lens opacification, or encapsulation.(4-7) Glaucoma drainage devices such as Ahmed valve, Molteno or Braeveldt valve can be used when other methods of treatment fail, they provide alternative pathway to the aqueous to be collected in a plate positioned under the conjunctiva, (8-10) Encapsulation is a major problem occurs around the end plate due to fibrous reaction and so the drainage of the aqueous is decreased , Epatein (11) attributed that to fibro vascular proliferation in the episcleral tissue .the fibrous reaction is multifactorial , it may be due to the size of the end plate, the biomaterial, design or the shape of the plate.
The use of drainage devices with advanced drug delivery system can improve the success of drainage device.
A double-layered porous coating for Ahmed glaucoma valves based on biodegradable poly(lactic-co-glycolic acid) (PLGA) was described by Ponnusamy et al. [12] to produce continuous release of antifibrotic agents [mitomycin C (MMC) and/or 5-fluorouracil (5-FU)] to the subconjunctival space. This release continue for about one month with decreasing fibrosis, the nanofiltration membrane could entrap the proteins passing out from the anterior chamber leading to minimal increase in aqueous resistance.(12-13)
Read the detailed description
All participants will be evaluated regarding the following:
Visual acuity (VA) will be measured before and after surgery. Visual field (VF) will be assessed. Optical coherence topography (OCT) Ahmed valve coated with PLGA nanoparticles saturated with Mitomycin-C 2mg/ml. Follow up will continue for one year regarding intraocular pressure IOP, VA , VF, OCT and occurrence of complications such as erosion, extrusion, infection, encapsulation and fibrosis around the stent.
Data will be collected and analyzed.
- Conditions
- Glaucoma
- Being tested
- Ahmed Valve
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ahmed ValveProcedure or surgery
Ahmed valve implantation coated with poly lactic -co-glycolic acid (PLGA) saturated with Mitomycin-C in the management of adult onset glaucoma in Sturge Weber syndrome
| Study group | Role | What they receive |
|---|---|---|
| Ahmed valve coated with PLGA is implanted in secondary glaucoma in Sturge Weber syndrome | Experimental | Ahmed valve coated with PLGA is implanted in secondary glaucoma in Sturge Weber syndrome Receives: Procedure: Ahmed Valve |
| Ahmed valve implanted in secondary glaucoma in Sturge Weber syndrome | Active comparator | Ahmed valve will be implanted alone with no PLGA Receives: Procedure: Ahmed Valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP in mmg
efficacy of Ahmed valve implantation coated with PLGA sturated with MMC
Measured: one year
Incidence of complications
to assess complications regarding the flap , erosions to the conjunctiva , extrusion , endothelial toxicity.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start15 Oct 2021
- Primary completion15 Dec 2022 (estimated)
- Study completion15 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany Mahmoud, Sohag University
- Investigators
- Hany Mahmoud, MD, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735601
- Sponsor's protocol ID
- S20-161
- Status last verified
- Mar 2022
- First submitted
- 23 Jan 2021
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ahmed Valve Implantation Coated With Poly Lactic -Co-glycolic Acid (PLGA) Saturated With Mitomycin-C in the Management of Adult Onset Glaucoma in Sturge Weber Syndrome
- ClinicalTrials.gov ID
- NCT04735601
- Acronym / sponsor ID
- S20-161
- Conditions
- Glaucoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 15 Dec 2022 (estimated)
- Study completion
- 15 Dec 2022 (estimated)
- First posted
- 3 Feb 2021 (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.
Sturge weber's syndrome is an oculcutaneous syndrome, ocular manifestations may include heamangioma in the eye lids, choroidal heamangioma, or glaucoma, the glaucoma may present at infancy and may be due to resistance to aqueous outflow through trabecular meshwork(1), it may develop later and this is due to episcleral venous raised pressure.(2-3) Glaucoma associated with Sturge weber syndrome is difficult to be treated medically with high risk of complications when treated with bleb -based surgeries. Suprachoroidal hemorrhage or detachment is a challenging complication which must be encountered.
The usage of Ahmed valve in the management of glaucoma associated with Sturge weber syndrome is a bleb based procedure carries the risks of over filtration or encapsulation and decreased filtration with failure to control glaucoma.
The use of Ahmed valve in the management of pediatric glaucoma associated with Sturge weber syndrome has better results as recorded by Nassiri et al. Ahmed valve implantation can have some drawbacks such as pupillary irregularity, lens opacification, or encapsulation.(4-7) Glaucoma drainage devices such as Ahmed valve, Molteno or Braeveldt valve can be used when other methods of treatment fail, they provide alternative pathway to the aqueous to be collected in a plate positioned under the conjunctiva, (8-10) Encapsulation is a major problem occurs around the end plate due to fibrous reaction and so the drainage of the aqueous is decreased , Epatein (11) attributed that to fibro vascular proliferation in the episcleral tissue .the fibrous reaction is multifactorial , it may be due to the size of the end plate, the biomaterial, design or the shape of the plate.
The use of drainage devices with advanced drug delivery system can improve the success of drainage device.
A double-layered porous coating for Ahmed glaucoma valves based on biodegradable poly(lactic-co-glycolic acid) (PLGA) was described by Ponnusamy et al. [12] to produce continuous release of antifibrotic agents [mitomycin C (MMC) and/or 5-fluorouracil (5-FU)] to the subconjunctival space. This release continue for about one month with decreasing fibrosis, the nanofiltration membrane could entrap the proteins passing out from the anterior chamber leading to minimal increase in aqueous resistance.(12-13)
Detailed description
All participants will be evaluated regarding the following:
Visual acuity (VA) will be measured before and after surgery. Visual field (VF) will be assessed. Optical coherence topography (OCT) Ahmed valve coated with PLGA nanoparticles saturated with Mitomycin-C 2mg/ml. Follow up will continue for one year regarding intraocular pressure IOP, VA , VF, OCT and occurrence of complications such as erosion, extrusion, infection, encapsulation and fibrosis around the stent.
Data will be collected and analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ahmed valve coated with PLGA is implanted in secondary glaucoma in Sturge Weber syndrome | Experimental | Procedure: Ahmed ValveAhmed valve coated with PLGA is implanted in secondary glaucoma in Sturge Weber syndrome |
| Ahmed valve implanted in secondary glaucoma in Sturge Weber syndrome | Active comparator | Procedure: Ahmed ValveAhmed valve will be implanted alone with no PLGA |
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 suffered from adult onset Sturge Weber syndrome and subjected to Ahmed valve implantation.
Key exclusion criteria (2 listed)
- other ocular pathology; choroidal heamangioma, cataract, exudative retinal detachment.
- Patients under 18 years old
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 |
|---|---|---|
| Ahmed ValveAhmed valve implantation coated with poly lactic -co-glycolic acid (PLGA) saturated with Mitomycin-C in the management of adult onset glaucoma in Sturge Weber syndrome | Procedure or surgery | Ahmed valve coated with PLGA is implanted in secondary glaucoma in Sturge Weber syndrome, Ahmed valve implanted in secondary glaucoma in Sturge Weber syndrome |
Primary outcome
IOP in mmg
Time frame: one year
efficacy of Ahmed valve implantation coated with PLGA sturated with MMC
Incidence of complications
Time frame: one year
to assess complications regarding the flap , erosions to the conjunctiva , extrusion , endothelial toxicity.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: Yes
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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.
Hany Mahmoud, MD principal investigator
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ahmed Valve in people with Glaucoma, run by Sohag 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 2 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 Apr 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 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Hany Mahmoud, MD (01024368111, drhanymahmoud@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IOP in mmg (time frame: one year). 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 Apr 2022.