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Status unknownNCT04735601Updated Apr 6, 2022

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 interventional study of Ahmed Valve in Glaucoma, sponsored by Sohag University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-06.

Sponsored by Sohag University · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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)

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.

02

Conditions studied

03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients suffered from adult onset Sturge Weber syndrome and subjected to Ahmed valve implantation.

Exclusion criteria

Exclusion Criteria:

  • other ocular pathology; choroidal heamangioma, cataract, exudative retinal detachment.

Patients under 18 years old

04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Ahmed valve coated with PLGA is implanted in secondary glaucoma in Sturge Weber syndrome

    Ahmed valve coated with PLGA is implanted in secondary glaucoma in Sturge Weber syndrome

    Procedure: Ahmed Valve

  • Active comparator
    Ahmed valve implanted in secondary glaucoma in Sturge Weber syndrome

    Ahmed valve will be implanted alone with no PLGA

    Procedure: Ahmed Valve

Interventions

  • ProcedureAhmed Valve

    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

05

What researchers measure

Primary outcomes

  1. IOP in mmg

    efficacy of Ahmed valve implantation coated with PLGA sturated with MMC

    Time frame: one year

  2. Incidence of complications

    to assess complications regarding the flap , erosions to the conjunctiva , extrusion , endothelial toxicity.

    Time frame: one year

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04735601
Lead sponsor
Sohag University
Responsible party
Hany Mahmoud (principal investigator, Sohag University) — Principal investigator
First posted
Feb 3, 2021
Start date
Oct 15, 2021
Primary completion
Dec 15, 2022 (estimated)
Completion
Dec 15, 2022 (estimated)
Last update
Apr 6, 2022

Study contacts

Hany Mahmoud, MD
Contact
drhanymahmoud@gmail.com
01024368111
Hany Mahmoud, MD
Contact
drhanymahmoud@med.sohag.edu.eg
01024368111
Hany Mahmoud, MD
principal investigator · Sohag University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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