Ologen (OculusGen)-Glaucoma Case Control Trial in India

June 26, 2017 updated by: Pro Top & Mediking Company Limited

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Andhra Prades
      • Hyderabad, Andhra Prades, India, 500 034
        • L. V. Prasad Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Trabeculectomy with Oculusgen
Device: OculusGen Biodegradable Collagen Matrix Implant
Trabeculectomy with OculusGen Biodegradable Collagen Matrix Implant
No Intervention: Trabeculectomy without Oculusgen or antifibrotic agents

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pro Top & Mediking Company Limited

Investigators

  • Principal Investigator: Anil Mandal, MD, V. S. T. Glaucoma Services, L. V. Prasad Eye Institute,

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2007

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

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 (Actual)

June 27, 2017

Last Update Submitted That Met QC Criteria

June 26, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mediking 0702
  • OculusGen-2006-03-20

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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