Ologen (OculusGen)-Glaucoma Case Control Trial in India

This study is currently recruiting participants.

Verified October 2011 by Pro Top & Mediking Company Limited

Sponsor:

Information provided by (Responsible Party):

Pro Top & Mediking Company Limited

ClinicalTrials.gov Identifier:

NCT00448929

First received: March 15, 2007

Last updated: October 6, 2011

Last verified: October 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

March 15, 2007

Last Updated Date

October 6, 2011

Start Date ^ICMJE

January 2007

Estimated Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

the effectiveness via the reduction of IOP [ Time Frame: 180 day ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

IOP < 21mmHg with no glaucoma medications on the day of 180th after surgery and at least a 20% reduction from baseline IOP.

Change History

Complete list of historical versions of study NCT00448929 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

the safety via the incidence of complications and adverse events. [ Time Frame: 180 day ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

IOP < 21mmHg with glaucoma medications, or IOP ≧ 21 mmHg but reduction of IOP greater than or equal to 30% with/without glaucoma medications

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Ologen (OculusGen)-Glaucoma Case Control Trial in India

Official Title ^ICMJE

Comparative Study of the Safety and Effectiveness Between Trabeculectomy and Trabeculectomy With Ologen (OculusGen) Collagen Matrix Implant

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

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.
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.
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 ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Glaucoma

Intervention ^ICMJE

Device: OculusGen Biodegradable Collagen Matrix Implant

Trabeculectomy with OculusGen Biodegradable Collagen Matrix Implant

Study Arm (s)

Experimental: Trabeculectomy with Oculusgen
Intervention: Device: OculusGen Biodegradable Collagen Matrix Implant
No Intervention: Trabeculectomy without Oculusgen or antifibrotic agents

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

October 2011

Estimated Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

30 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Arslan Tsai, Pharma

+886 2 27088558 ext 116

arslan.tsai@aeonastron.net

Location Countries ^ICMJE

India

Administrative Information

NCT Number ^ICMJE

NCT00448929

Other Study ID Numbers ^ICMJE

Mediking 0702, OculusGen-2006-03-20

Has Data Monitoring Committee

Not Provided

Responsible Party

Pro Top & Mediking Company Limited

Study Sponsor ^ICMJE

Pro Top & Mediking Company Limited

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Anil Mandal, MD

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

Information Provided By

Pro Top & Mediking Company Limited

Verification Date

October 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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