Ologen (OculusGen)-Glaucoma Case Control Trial in India

NCT ID: NCT00448929

Last Updated: 2017-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2011-10-31

Brief Summary

The purpose of this study is to compare the safety and effectiveness of trabeculectomy with ologen (OculusGen) Biodegradable Collagen Matrix Implant and trabeculectomy without antifibrotic agents.

Detailed Description

1. Study Objective: To determine the safety and effectiveness of the ologen (OculusGen) Biodegradable Collagen Matrix Implant 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 without antifibrotics.

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.

Conditions

Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Trabeculectomy with Oculusgen

Group Type: EXPERIMENTAL

OculusGen Biodegradable Collagen Matrix Implant

Intervention Type: DEVICE

Trabeculectomy with OculusGen Biodegradable Collagen Matrix Implant

Trabeculectomy without Oculusgen or antifibrotic agents

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

OculusGen Biodegradable Collagen Matrix Implant

Trabeculectomy with OculusGen Biodegradable Collagen Matrix Implant

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age 30 years or over.
• No previous intraocular operative surgery
• 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 porcine collagen.
• Subject is on warfarin and discontinuation is not recommended.
• Patient who has been diagnosed for one of following glaucoma: normal tension glaucoma, uveitic glaucoma, aphakia or pseudophakia glaucoma, neovascular glaucoma and other classified secondary glaucoma.
• Participation in an investigational study during the 30 days proceeding trabeculectomy.
• Ocular infection within 14 days prior to trabeculectomy.
• Pregnant or breast-feeding women

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pro Top & Mediking Company Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anil Mandal, MD

Role: PRINCIPAL_INVESTIGATOR

V. S. T. Glaucoma Services, L. V. Prasad Eye Institute,

Locations

L. V. Prasad Eye Institute

Hyderabad, Andhra Pradesh, India

Countries

India

References

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.

Reference Type: RESULT

PMID: 17122118 (View on PubMed)

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.

Reference Type: RESULT

PMID: 10937547 (View on PubMed)

Park J, Rittiphairoj T, Wang X, E JY, Bicket AK. Device-modified trabeculectomy for glaucoma. Cochrane Database Syst Rev. 2023 Mar 13;3(3):CD010472. doi: 10.1002/14651858.CD010472.pub3.

Reference Type: DERIVED

PMID: 36912740 (View on PubMed)

Other Identifiers

OculusGen-2006-03-20

Identifier Type: -

Identifier Source: secondary_id

Mediking 0702

Identifier Type: -

Identifier Source: org_study_id