Ologen (OculusGen)-Glaucoma MMC Control Trial in India

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

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.

Study Overview

• Status: Unknown
• Conditions: Glaucoma
• Intervention / Treatment: Device: OculusGen Biodegradable Collagen Matrix Implant; Drug: Trabeculectomy with MMC

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Andhra Prades
    • Hyderabad, Andhra Prades, India, 500 034
      • Recruiting
      • L. V. Prasad Eye Institute
      • Contact: Rajul S Parikh, MD; Phone Number: +91 40 3061 2345; Email: rajulparikh@lvpei.org
      • Contact: G Chandrasekhar, MD; Phone Number: +91 40 3061 2345; Email: gcs@lvpei.org
      • Sub-Investigator: Anil Mandal, MD
      • Sub-Investigator: G Chandrasekhar, MD
      • Principal Investigator: Rajul S Parikh, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OculusGen Biodegradable Collagen Matrix Implant; Trabeculectomy with OculusGen Biodegradable Collagen Matrix Implant	Device: OculusGen Biodegradable Collagen Matrix Implant; Trabeculectomy with OculusGen Biodegradable Collagen Matrix Implant
Active Comparator: MMC; Trabeculectomy with MMC	Drug: Trabeculectomy with MMC; Trabeculectomy with MMC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the effectiveness via the reduction of IOP	180 day

Secondary Outcome Measures

Outcome Measure	Time Frame
the safety via the incidence of complications and adverse events.	180 day

Collaborators and Investigators

• Sponsor: Pro Top & Mediking Company Limited
• Investigators: Principal Investigator: Rajul S Parikh, MD, V. S. T. Glaucoma Services, L. V. Prasad Eye Institute,

Publications and helpful links

General Publications

• 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. doi: 10.1167/iovs.06-0378. Erratum In: Invest Ophthalmol Vis Sci. 2007 Feb;48(2):485.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Anticipated): October 1, 2011
• Study Completion (Anticipated): October 1, 2011

Study Registration Dates

• First Submitted: March 15, 2007
• First Submitted That Met QC Criteria: March 15, 2007
• First Posted (Estimate): March 19, 2007

Study Record Updates

• Last Update Posted (Estimate): October 7, 2011
• Last Update Submitted That Met QC Criteria: October 6, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: Glaucoma; tissue engineering; Trabeculectomy; ologen; Aeon Astron; Collagen matrix; OculusGen; anti scarring; high risk patient for trabeculectomy
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: Mediking 0701; OculusGen-2006-02-20