Oculusgen (Ologen) Glaucoma MMC Control in Estonia

This study is currently recruiting participants.

Verified October 2011 by Pro Top & Mediking Company Limited

Sponsor:

Information provided by (Responsible Party):

Pro Top & Mediking Company Limited

ClinicalTrials.gov Identifier:

NCT00524758

First received: September 4, 2007

Last updated: October 24, 2011

Last verified: October 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 4, 2007

Last Updated Date

October 24, 2011

Start Date ^ICMJE

July 2007

Estimated Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

IOP <21mmHg without anti glaucoma medication [ Time Frame: 180 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

IOP <21mmHg without anti glaucoma medication [ Time Frame: 180 days ]

Change History

Complete list of historical versions of study NCT00524758 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

IOP<21mmHg or IOP drops more than 30% with anti glaucoma medication [ Time Frame: 180-day ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

IOP<21mmHg or IOP drops more than 30% with anti glaucoma medication [ Time Frame: 180-day ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Oculusgen (Ologen) Glaucoma MMC Control in Estonia

Official Title ^ICMJE

Comprative Study of the Safety and Effectiveness Between Oculusgen (Ologen) Collagen Matrix Implant and Mitomycin-C in Glaucoma Filtering Surgery

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Open Angle Glaucoma
Angle Closure Glaucoma
Uveitis Glaucoma
Young Age Glaucoma
Neovascular Glaucoma
High Risk Patient

Intervention ^ICMJE

Device: ologen (oculusgen) collagen matrix
Implant ologen collagen matrix on the top of sclera flap after loose stiched the sclera flap. The traditional trabeculectomy is performed.
Other Names:
- ologen collagen matrix
- oculusgen collagen matrix
Drug: MMC in Trabeculectomy
MMC in Trabeculectomy

Study Arm (s)

Experimental: Ologen in Trabeculectomy
Ologen in Trabeculectomy

Intervention: Device: ologen (oculusgen) collagen matrix
Active Comparator: MMC in Trabeculectomy
MMC in Trabeculectomy

Intervention: Drug: MMC in Trabeculectomy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

October 2011

Estimated Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Max anti glaucoma medication failed,

Exclusion Criteria:

Age less than 18, woman in pregnant, hemodialysis patient

Gender

Both

Ages

19 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Arslan Tsai, Pharma/ MSc EFM

+886 2 27088558 ext 116

arslan.tsai@aeonastron.net

Location Countries ^ICMJE

Estonia

Administrative Information

NCT Number ^ICMJE

NCT00524758

Other Study ID Numbers ^ICMJE

oculusgen 2006-02-20

Has Data Monitoring Committee

Yes

Responsible Party

Pro Top & Mediking Company Limited

Study Sponsor ^ICMJE

Pro Top & Mediking Company Limited

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Kuldar Kaljurand, MD

University of Tartu

Information Provided By

Pro Top & Mediking Company Limited

Verification Date

October 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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