Oculusgen (Ologen) Glaucoma MMC Control in Estonia
Primary Purpose
Open Angle Glaucoma, Angle Closure Glaucoma, Uveitis Glaucoma
Status
Completed
Phase
Phase 3
Locations
Estonia
Study Type
Interventional
Intervention
ologen (oculusgen) collagen matrix
MMC in Trabeculectomy
Sponsored by
About this trial
This is an interventional treatment trial for Open Angle Glaucoma focused on measuring ologen, oculusgen, collagen matrix, trabeculectomy, filtering surgery, mitomycin-C, MMC, Aeon Astron
Eligibility Criteria
Inclusion Criteria:
- Max anti glaucoma medication failed,
Exclusion Criteria:
- Age less than 18, woman in pregnant, hemodialysis patient
Sites / Locations
- Tartu University Clinics
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ologen in Trabeculectomy
MMC in Trabeculectomy
Arm Description
Ologen in Trabeculectomy
MMC in Trabeculectomy
Outcomes
Primary Outcome Measures
IOP <21mmHg without anti glaucoma medication
Secondary Outcome Measures
IOP<21mmHg or IOP drops more than 30% with anti glaucoma medication
Full Information
NCT ID
NCT00524758
First Posted
September 4, 2007
Last Updated
June 26, 2017
Sponsor
Pro Top & Mediking Company Limited
1. Study Identification
Unique Protocol Identification Number
NCT00524758
Brief Title
Oculusgen (Ologen) Glaucoma MMC Control in Estonia
Official Title
Comprative Study of the Safety and Effectiveness Between Oculusgen (Ologen) Collagen Matrix Implant and Mitomycin-C in Glaucoma Filtering Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pro Top & Mediking Company Limited
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To compare the safety and effectiveness between ologen collagen matrix and mitomycin-C (MMC) in glaucoma surgery.
The ologen collagen matrix implantation procedure is same as traditional trabeculectomy except implant the ologen collagen matrix on the top of sclera flap after one loose stich the sclera flap. The MMC application is as the standard.
Detailed Description
Ologen collagen matrix is implanted on the top of sclera flap after the loose stich sclera flap is done for the filtering surgery. The concept of ologen collagen matrix is to creat the subconjunctiva bleb and modulate the wound healing for the surgery. By implanting ologen collagen matrix in the place, subconjuctival and trabdoor scars might be prevented. This is because the ologen collagen matrix is a 3-D scaffold porous structure that can guide fibroblast to grow randomly, instead of linear alignment. This can reduce the scar formation.
Doctors apply MMC for the glaucoma surgery is also trying to inhibite the scar formation. But MMC has been long time used and glaucoma specialists have not found anything to replace it.
Ologen collagen matrix concept is not INHIBITION, it is guiding and creating a physiological tissue. The successful of ologen collagen matrix may be on par with MMC but the safety and side effects will be much less.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Angle Glaucoma, Angle Closure Glaucoma, Uveitis Glaucoma, Young Age Glaucoma, Neovascular Glaucoma, High Risk Patient
Keywords
ologen, oculusgen, collagen matrix, trabeculectomy, filtering surgery, mitomycin-C, MMC, Aeon Astron
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ologen in Trabeculectomy
Arm Type
Experimental
Arm Description
Ologen in Trabeculectomy
Arm Title
MMC in Trabeculectomy
Arm Type
Active Comparator
Arm Description
MMC in Trabeculectomy
Intervention Type
Device
Intervention Name(s)
ologen (oculusgen) collagen matrix
Other Intervention Name(s)
ologen collagen matrix, oculusgen collagen matrix
Intervention Description
Implant ologen collagen matrix on the top of sclera flap after loose stiched the sclera flap. The traditional trabeculectomy is performed.
Intervention Type
Drug
Intervention Name(s)
MMC in Trabeculectomy
Intervention Description
MMC in Trabeculectomy
Primary Outcome Measure Information:
Title
IOP <21mmHg without anti glaucoma medication
Time Frame
180 days
Secondary Outcome Measure Information:
Title
IOP<21mmHg or IOP drops more than 30% with anti glaucoma medication
Time Frame
180-day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Max anti glaucoma medication failed,
Exclusion Criteria:
Age less than 18, woman in pregnant, hemodialysis patient
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuldar Kaljurand, MD
Organizational Affiliation
University of Tartu
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tartu University Clinics
City
Tartu
Country
Estonia
12. IPD Sharing Statement
Learn more about this trial
Oculusgen (Ologen) Glaucoma MMC Control in Estonia
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