Oculusgen (Ologen) Glaucoma MMC Control in Estonia

The recruitment status of this study is unknown because the information has not been verified recently.
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
  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
Endpoint Classification: Safety/Efficacy Study
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:


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

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

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

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
Genders Eligible for Study:   Both
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

Additional Information:
No publications provided

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
Health Authority: Estonia: Ministry of Health

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, Angle-Closure
Glaucoma, Neovascular
Glaucoma, Open-Angle
Uveitis
Chorioretinitis
Ocular Hypertension
Eye Diseases
Uveal Diseases
Retinitis
Retinal Diseases
Choroiditis
Choroid Diseases
Uveitis, Posterior
Panuveitis
Mitomycin
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Alkylating Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014