Ologen Collagen Matrix Safety and Effective Comparison With Mitomycin-C(MMC) in Glaucoma Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pro Top & Mediking Company Limited
ClinicalTrials.gov Identifier:
NCT00538590
First received: September 29, 2007
Last updated: April 1, 2012
Last verified: April 2012
  Purpose

To compare the safety and effectiveness of oculusgen (ologen) collagen matrix implantation and Mitomycin-C(MMC) in glaucoma surgery.


Condition Intervention Phase
Open Angle Glaucoma
Device: Collagen Matrix in Glaucoma Filtering Surgery
Drug: Mitomycin-C(MMC) and glaucoma filtering surgery
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ologen Collagen Matrix Safety and Effective Comparison With Mitomycin-C(MMC) in Glaucoma Surgery

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Postoperative Intraocular Pressure Change [ Time Frame: 360 days ] [ Designated as safety issue: No ]
    Postoperative intraocular pressure change at 360 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.

  • Postoperative Intraocular Pressure Change [ Time Frame: 180 days ] [ Designated as safety issue: No ]
    Postoperative intraocular pressure change at 180 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.

  • Postoperative Intraocular Pressure Change [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Postoperative intraocular pressure change at 90 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.

  • Postoperative Intraocular Pressure Change [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Postoperative intraocular pressure change at 30 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure.


Secondary Outcome Measures:
  • Complications [ Time Frame: 360 days ] [ Designated as safety issue: Yes ]
    Incidence (percentage) for complications recorded: Hyphema, early hypotony(<7days), late hypotony(>7days), shallow anterior chamber, choroidal detachment, early leak(<7days), late leak(>7days), Tenon's cysts, and revision surgery for up to 360 days.


Enrollment: 20
Study Start Date: July 2007
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MITOMYCIN-C
Following ethics committee approval, 20 patients with uncontrolled glaucoma will be will be recruited according to the enrollment acceptance criteria. Randomisation is performed and patients are allocated for trabeculectomy with Mitomycin-C.
Drug: Mitomycin-C(MMC) and glaucoma filtering surgery
If mitomycin -C is applied, a single cellulose sponge soaked with Mitomycin-C(MMC) (0.2mg/ml - 0.4mg/ml) is fashioned into an approximate 2.0 × 4.0 mm rectangular shape and applied to the scleral bed and subconjunctival space taking care to avoid exposure to the conjunctival wound edge. Application time is 2 minutes for MMC. Then, the area treated is copiously irrigated with balanced salt solution. After operation, appropriate anti-inflammatory and antibiotic eye-drops will be prescribed.
Other Name: Mitomycin C
Experimental: ologen (Oculusgen)
20 patients will be recruited according to the enrollment acceptance criteria. Randomisation is performed and patients are allocated for trabeculectomy with ologen implant. The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
Device: Collagen Matrix in Glaucoma Filtering Surgery
Collagen Matrix implantation in Glaucoma Filtering Surgery
Other Name: ologen™

Detailed Description:

To compare the safety and effectiveness in between oculusgen (ologen) collagen matrix implantation and Mitomycin-C(MMC) for glaucoma surgery. The surgery is performed by the gold standard of trabeculectomy. Mitomycin-C(MMC) is applied for those who not collagen matrix implanted.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Open angle glaucoma
  • Maxima anti-glaucoma medication failed
  • Age>18
  • Able to complete the follow up

Exclusion Criteria:

  • Topical eye inflammation
  • Angle closure glaucoma
  • Deformity glaucoma
  • One eye glaucoma
  • Previous conjunctiva opened
  • Allergy to collagen
  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: NCT00538590

Locations
Germany
Hospital of Universität Köln
Koln, Germany, 50931
Sponsors and Collaborators
Pro Top & Mediking Company Limited
Investigators
Principal Investigator: Thomas Dietlein, Ph. D, MD Universität Köln
  More Information

Additional Information:
No publications provided

Responsible Party: Pro Top & Mediking Company Limited
ClinicalTrials.gov Identifier: NCT00538590     History of Changes
Other Study ID Numbers: ologen-Koln
Study First Received: September 29, 2007
Results First Received: January 19, 2012
Last Updated: April 1, 2012
Health Authority: Bundesinstitut für Arzneimittel und Medizinprodukte in Bonn: Germany

Keywords provided by Pro Top & Mediking Company Limited:
ologen
collagen matrix
glaucoma
trabeculectomy
Mitomycin-C

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Alkylating Agents

ClinicalTrials.gov processed this record on July 10, 2014