OculusGen-Glaucoma Historical Control Study in Taiwan

Glaucoma Clinical Trial

Official title:

Study of the Safety and Effectiveness of the OculusGen Collagen Matrix Implant as an Aid in Glaucoma Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00406822
• Other study ID #: Mediking 0502
• Status: Terminated
• Phase: Phase 3
• First received: October 10, 2006
• Last updated: April 25, 2008
• Start date: December 2006

Study information

• Verified date: June 2007
• Source: Pro Top & Mediking Company Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether the OculusGen Collagen Matrix are effective and safe to implant as an aid of glaucoma surgery.

Description:

OculusGen® Collagen Matrix is a porous, scaffold matrix. It is to be implanted on the top of the scleral flap and beneath the conjunctiva and Tenon's capsule at the end of trabeculectomy. The pores in the scaffold matrix range from 20 to 200µm, a size that is suitable for fibroblasts to grow randomly, through the body of the matrix without causing scarring. The space occupied by the collagen matrix scaffold creates room for the development of a filtration bleb. Immediately after implantation, the collagen matrix is absorbed with the aqueous humor that bring a certain pressure press on the top of scleral flap which makes the dynamic balance for the aqueous system to keep the IOP in the right side. The collagen matrix is bio-degraded within 90 days and will leave a physiologic space for the filtration bleb to facilitate control of intraocular pressure (IOP).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Subject inclusion criteria:

1. Age 18 years or over.

2. At least one eye diagnosed with glaucoma and receiving maximally tolerated medical therapy.

3. Subject able and willing to cooperate with investigation plan.

4. Subject able and willing to complete postoperative follow-up requirements.

5. Subject willing to sign informed consent form.

Subject exclusion criteria:

1. Have allergic reactions to collagen

2. Subject is taking anticoagulation and/or the physician does not suggested to stop taking the medication

3. Normal tension glaucoma patient

4. Subject has one eye received OculusGen™ implantation

5. Subject who been diagnosed infection with the operation eye

6. Subject with anterior chamber abnormality

7. Subject with steroid glaucoma

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

Device:
• OculusGen Biodegradable Collagen Matrix Implant

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital -Taipei Branch	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Pro Top & Mediking Company Limited

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Hsu WC, Spilker MH, Yannas IV, Rubin PA. Inhibition of conjunctival scarring and contraction by a porous collagen-glycosaminoglycan implant. Invest Ophthalmol Vis Sci. 2000 Aug;41(9):2404-11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the effectiveness via the reduction of IOP		180 day
Secondary	the safety via the incidence of complications and adverse events.		180day