Oculusgen (Ologen) Glaucoma MMC Control in Estonia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified October 2011 by Pro Top & Mediking Company Limited.
Recruitment status was: Recruiting

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

Purpose

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.

Condition	Intervention	Phase
Open Angle Glaucoma Angle Closure Glaucoma Uveitis Glaucoma Young Age Glaucoma Neovascular Glaucoma High Risk Patient	Device: ologen (oculusgen) collagen matrix Drug: MMC in Trabeculectomy	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Comprative Study of the Safety and Effectiveness Between Oculusgen (Ologen) Collagen Matrix Implant and Mitomycin-C in Glaucoma Filtering Surgery

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

Genetic and Rare Diseases Information Center resources: Pigment-dispersion Syndrome Uveal Diseases

U.S. FDA Resources

Further study details as provided by Pro Top & Mediking Company Limited:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


Estimated Enrollment:	20
Study Start Date:	July 2007
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Ologen in Trabeculectomy Ologen in Trabeculectomy	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
Active Comparator: MMC in Trabeculectomy MMC in Trabeculectomy	Drug: MMC in Trabeculectomy MMC in Trabeculectomy

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.

Eligibility


Ages Eligible for Study:	19 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Max anti glaucoma medication failed,

Exclusion Criteria:

Age less than 18, woman in pregnant, hemodialysis patient

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00524758

Contacts


Contact: Arslan Tsai, Pharma/ MSc EFM	+886 2 27088558 ext 116	arslan.tsai@aeonastron.net

Locations


Estonia
Tartu University Clinics	Recruiting
Tartu, Estonia
Contact: Kuldar Kaljurand, MD +372 737 6189 kristel.mikkor@ut.ee
Principal Investigator: Kuldar Kaljurand, MD

Sponsors and Collaborators

Pro Top & Mediking Company Limited

Investigators


Principal Investigator:	Kuldar Kaljurand, MD	University of Tartu

More Information


Responsible Party:	Pro Top & Mediking Company Limited
ClinicalTrials.gov Identifier:	NCT00524758 History of Changes
Other Study ID Numbers:	oculusgen 2006-02-20
Study First Received:	September 4, 2007
Last Updated:	October 24, 2011

Keywords provided by Pro Top & Mediking Company Limited:


ologen oculusgen collagen matrix trabeculectomy	filtering surgery mitomycin-C MMC Aeon Astron

Additional relevant MeSH terms:


Glaucoma Glaucoma, Open-Angle Uveitis Glaucoma, Angle-Closure Glaucoma, Neovascular Ocular Hypertension Eye Diseases Uveal Diseases	Mitomycins Mitomycin Antibiotics, Antineoplastic Antineoplastic Agents Alkylating Agents Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors

ClinicalTrials.gov processed this record on June 23, 2017

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