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Ologen (OculusGen)-Glaucoma Case Control Trial in India

Primary Purpose

Glaucoma

Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
OculusGen Biodegradable Collagen Matrix Implant
Sponsored by
Pro Top & Mediking Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma, Collagen matrix, ologen, OculusGen, Trabeculectomy

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • L. V. Prasad Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Trabeculectomy with Oculusgen

Trabeculectomy without Oculusgen or antifibrotic agents

Arm Description

Outcomes

Primary Outcome Measures

the effectiveness via the reduction of IOP

Secondary Outcome Measures

the safety via the incidence of complications and adverse events.

Full Information

First Posted
March 15, 2007
Last Updated
June 26, 2017
Sponsor
Pro Top & Mediking Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT00448929
Brief Title
Ologen (OculusGen)-Glaucoma Case Control Trial in India
Official Title
Comparative Study of the Safety and Effectiveness Between Trabeculectomy and Trabeculectomy With Ologen (OculusGen) Collagen Matrix Implant
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
January 2007 (Actual)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pro Top & Mediking Company Limited

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Glaucoma, Collagen matrix, ologen, OculusGen, Trabeculectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trabeculectomy with Oculusgen
Arm Type
Experimental
Arm Title
Trabeculectomy without Oculusgen or antifibrotic agents
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
OculusGen Biodegradable Collagen Matrix Implant
Intervention Description
Trabeculectomy with OculusGen Biodegradable Collagen Matrix Implant
Primary Outcome Measure Information:
Title
the effectiveness via the reduction of IOP
Time Frame
180 day
Secondary Outcome Measure Information:
Title
the safety via the incidence of complications and adverse events.
Time Frame
180 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anil Mandal, MD
Organizational Affiliation
V. S. T. Glaucoma Services, L. V. Prasad Eye Institute,
Official's Role
Principal Investigator
Facility Information:
Facility Name
L. V. Prasad Eye Institute
City
Hyderabad
State/Province
Andhra Prades
ZIP/Postal Code
500 034
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
17122118
Citation
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.
Results Reference
result
PubMed Identifier
10937547
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.
Results Reference
result

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Ologen (OculusGen)-Glaucoma Case Control Trial in India

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