Ologen (OculusGen)-Glaucoma MMC Control in Pakistan

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: Completed

Administrative data

• NCT number: NCT00472810
• Other study ID #: Mediking 0703
• Secondary ID: OculusGen-2006-0
• Status: Completed
• Phase: Phase 3
• First received: May 11, 2007
• Last updated: October 6, 2011
• Start date: March 2007

Study information

• Verified date: October 2011
• Source: Pro Top & Mediking Company Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Ministry of Health. Pakistani secretariat, Lahore Punjab Pakistan.
• 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 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: Completed
• Enrollment: 40
• Est. primary completion date: May 2008
• 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 Bovine 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
• Trabeculectomy

Intervention

Device:
• ologen collagen matrix in glaucoma filtering surgery
If ologen™ treatment is used, the collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.

Drug:
• MMC in glaucoma filtering surgery
If mitomycin -C is applied, a single cellulose sponge soaked with 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.

Locations

Country	Name	City	State
Pakistan	RMC & Allied Hospital	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Pro Top & Mediking Company Limited

Country where clinical trial is conducted

Pakistan, 

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