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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

Primary Purpose

Glaucoma

Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Ahmed Valve
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sohag UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

Ahmed valve implanted in secondary glaucoma in Sturge Weber syndrome

Arm Description

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

Ahmed valve will be implanted alone with no PLGA

Outcomes

Primary Outcome Measures

IOP in mmg
efficacy of Ahmed valve implantation coated with PLGA sturated with MMC
Incidence of complications
to assess complications regarding the flap , erosions to the conjunctiva , extrusion , endothelial toxicity.

Secondary Outcome Measures

Full Information

First Posted
January 23, 2021
Last Updated
March 26, 2022
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT04735601
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2021 (Actual)
Primary Completion Date
December 15, 2022 (Anticipated)
Study Completion Date
December 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ahmed valve coated with PLGA is implanted in secondary glaucoma in Sturge Weber syndrome
Arm Type
Experimental
Arm Description
Ahmed valve coated with PLGA is implanted in secondary glaucoma in Sturge Weber syndrome
Arm Title
Ahmed valve implanted in secondary glaucoma in Sturge Weber syndrome
Arm Type
Active Comparator
Arm Description
Ahmed valve will be implanted alone with no PLGA
Intervention Type
Procedure
Intervention Name(s)
Ahmed Valve
Intervention Description
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
Primary Outcome Measure Information:
Title
IOP in mmg
Description
efficacy of Ahmed valve implantation coated with PLGA sturated with MMC
Time Frame
one year
Title
Incidence of complications
Description
to assess complications regarding the flap , erosions to the conjunctiva , extrusion , endothelial toxicity.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hany Mahmoud, MD
Phone
01024368111
Email
drhanymahmoud@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hany Mahmoud, MD
Phone
01024368111
Email
drhanymahmoud@med.sohag.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hany Mahmoud, MD
Organizational Affiliation
Sohag University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sohag University
City
Sohag
ZIP/Postal Code
82524
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hany Mahmoud
Phone
01024368111
Email
drhanymahmoud@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
one year

Learn more about this trial

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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