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

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)

Study Overview

• Status: Recruiting
• Conditions: Glaucoma
• Intervention / Treatment: Procedure: Ahmed Valve

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 Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Hany Mahmoud, MD; Phone Number: 01024368111; Email: drhanymahmoud@gmail.com
• Study Contact Backup: Name: Hany Mahmoud, MD; Phone Number: 01024368111; Email: drhanymahmoud@med.sohag.edu.eg

Study Locations

• Egypt
  • Sohag, Egypt, 82524
    • Recruiting
    • Sohag University
    • Contact: Hany Mahmoud; Phone Number: 01024368111; Email: drhanymahmoud@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Patients under 18 years old

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ahmed valve coated with PLGA is implanted in secondary glaucoma in Sturge Weber syndrome	Procedure: Ahmed 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
Active Comparator: Ahmed valve implanted in secondary glaucoma in Sturge Weber syndrome; Ahmed valve will be implanted alone with no PLGA	Procedure: Ahmed 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IOP in mmg	efficacy of Ahmed valve implantation coated with PLGA sturated with MMC	one year
Incidence of complications	to assess complications regarding the flap , erosions to the conjunctiva , extrusion , endothelial toxicity.	one year

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Principal Investigator: Hany Mahmoud, MD, Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2021
• Primary Completion (Anticipated): December 15, 2022
• Study Completion (Anticipated): December 15, 2022

Study Registration Dates

• First Submitted: January 23, 2021
• First Submitted That Met QC Criteria: February 2, 2021
• First Posted (Actual): February 3, 2021

Study Record Updates

• Last Update Posted (Actual): April 6, 2022
• Last Update Submitted That Met QC Criteria: March 26, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Eye Diseases; Ocular Hypertension; Brain Ischemia; Infarction; Stroke; Brain Infarction; Hemangioma; Neoplasms, Vascular Tissue; Neurocutaneous Syndromes; Angiomatosis; Glaucoma; Klippel-Trenaunay-Weber Syndrome; Sturge-Weber Syndrome; Brain Stem Infarctions
• Other Study ID Numbers: S20-161

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: one year
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes