Ologen (OculusGen)-Glaucoma MMC Control Trial in India

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00449098
• Other study ID #: Mediking 0701
• Secondary ID: OculusGen-2006-0
• Status: Recruiting
• Phase: Phase 4
• First received: March 15, 2007
• Last updated: October 6, 2011
• Start date: January 2007
• Est. completion date: October 2011

Study information

• Verified date: October 2011
• Source: Pro Top & Mediking Company Limited
• Contact: Arslan Tsai, Pharma
• Phone: +886 2 27088558
• Email: arslan.tsai[@]aeonastron.net
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the safety and effectiveness of the ologen (OculusGen) Biodegradable Collagen Matrix Implant and the MMC group in filtration surgery.

Description:

1. Study Objective: To compare the safety and effectiveness of the ologen (OculusGen) Biodegradable Collagen Matrix Implant and the MMC group in filtration surgery. The primary endpoint is to prove the effectiveness via the reduction of IOP, and the secondary endpoint is to prove the safety via the incidence of complications and adverse events.

2. Study Design: The study is designed as an open-label, randomized, parallel, comparative study. Patients who meet the inclusion/exclusion criteria and sign informed consent will be included. After enrollment, patients will be randomized into two groups: trabeculectomy with ologen (OculusGen) implant or trabeculectomy with mitomycin-C.

3. Follow-Up: There will be 7 post-operative and follow-up visits within 6 months of surgery: postoperative days 1, 7, 14, 30, 60, 90 and 180. A window of ± 7 days is allowed for the 30, 60, 90 day visits and ± 14 days for the 180 day visits. Further follow-up of subjects after the trial will be the responsibility of the investigator.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years or over.

• Uncontrolled glaucoma, with failed medical and laser treatment, requiring trabeculectomy.

• Subject able and willing to cooperate with investigation plan.

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

• Subject willing to sign informed consent form.

Exclusion Criteria:

• Known allergic reaction to mitomycin-C or porcine collagen.

• Subject is on warfarin and discontinuation is not recommended.

• Normal tension glaucoma.

• Participation in an investigational study during the 30 days preceding trabeculectomy.

• Ocular infection within 14 days prior to trabeculectomy.

• Pregnant or breast-feeding women.

Study Design

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

Device:
• OculusGen Biodegradable Collagen Matrix Implant
Trabeculectomy with OculusGen Biodegradable Collagen Matrix Implant

Drug:
• Trabeculectomy with MMC
Trabeculectomy with MMC

Locations

Country	Name	City	State
India	L. V. Prasad Eye Institute	Hyderabad	Andhra Prades

Sponsors (1)

Lead Sponsor	Collaborator
Pro Top & Mediking Company Limited

Country where clinical trial is conducted

India, 

References & Publications (2)

Chen HS, Ritch R, Krupin T, Hsu WC. Control of filtering bleb structure through tissue bioengineering: An animal model. Invest Ophthalmol Vis Sci. 2006 Dec;47(12):5310-4. Erratum in: Invest Ophthalmol Vis Sci. 2007 Feb;48(2):485. — View Citation

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	No
Secondary	the safety via the incidence of complications and adverse events.		180 day	Yes