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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

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ClinicalTrials.gov Identifier: NCT04735601
Recruitment Status : Recruiting
First Posted : February 3, 2021
Last Update Posted : March 22, 2021
Sponsor:
Information provided by (Responsible Party):
Hany Mahmoud, Sohag University

Study Description
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Brief 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)


Condition or disease Intervention/treatment Phase
Glaucoma Procedure: Ahmed Valve Early Phase 1

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : May 15, 2021
Estimated Primary Completion Date : August 15, 2021
Estimated Study Completion Date : August 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arms and Interventions
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Arm Intervention/treatment
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
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


Outcome Measures
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Primary Outcome Measures :
  1. IOP in mmg [ Time Frame: one year ]
    efficacy of Ahmed valve implantation coated with PLGA sturated with MMC

  2. Incidence of complications [ Time Frame: one year ]
    to assess complications regarding the flap , erosions to the conjunctiva , extrusion , endothelial toxicity.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04735601


Contacts
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Contact: Hany Mahmoud, MD 01024368111 drhanymahmoud@gmail.com
Contact: Hany Mahmoud, MD 01024368111 drhanymahmoud@med.sohag.edu.eg

Locations
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Egypt
Sohag University Recruiting
Sohag, Egypt, 82524
Contact: Hany Mahmoud    01024368111    drhanymahmoud@gmail.com   
Sponsors and Collaborators
Sohag University
Investigators
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Principal Investigator: Hany Mahmoud, MD Sohag University
More Information
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Responsible Party: Hany Mahmoud, principal investigator, Sohag University
ClinicalTrials.gov Identifier: NCT04735601    
Other Study ID Numbers: S20-161
First Posted: February 3, 2021    Key Record Dates
Last Update Posted: March 22, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: one year

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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
Additional relevant MeSH terms:
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Sturge-Weber Syndrome
Brain Stem Infarctions
Glaucoma
Klippel-Trenaunay-Weber Syndrome
Ocular Hypertension
Eye Diseases
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke
 Vascular Diseases
Cardiovascular Diseases
Infarction
Ischemia
Pathologic Processes
Necrosis
Angiomatosis
Hemangioma
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Neurocutaneous Syndromes