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

NCT04735601 | Unknown Phase 3 DMC FDA Drug

• 1 other identifier: S20-161
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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)

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

Procedure: Ahmed Valve

Ahmed valve implanted in secondary glaucoma in Sturge Weber syndrome

ACTIVE COMPARATOR

Ahmed valve will be implanted alone with no PLGA

Procedure: Ahmed Valve

Interventions

Ahmed Valve PROCEDURE

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• other ocular pathology; choroidal heamangioma, cataract, exudative retinal detachment.
• Patients under 18 years old

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University

Sohag, 82524, Egypt

RECRUITING

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Hany Mahmoud, MD

  Sohag University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hany Mahmoud, MD

CONTACT

01024368111; drhanymahmoud@gmail.com

Hany Mahmoud, MD

CONTACT

01024368111; drhanymahmoud@med.sohag.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: January 23, 2021
• First Posted: February 3, 2021
• Study Start: October 15, 2021
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: April 6, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: one year

Locations

EG (1)