Ologen (OculusGen)-Glaucoma Case Control Trial in India - Full Text View

Purpose

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

Condition	Intervention	Phase
Glaucoma	Device: OculusGen Biodegradable Collagen Matrix Implant	Phase III

Genetics Home Reference related topics:

early-onset glaucoma

MedlinePlus related topics:

Glaucoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Pro Top & Mediking Company Limited:

Primary Outcome Measures:

the effectiveness via the reduction of IOP [ Time Frame: 180 day ]

Secondary Outcome Measures:

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

Estimated Enrollment:	40
Study Start Date:	January 2007

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.

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00448929

Contacts


Contact: Castro Gabriel, MD	+886 2 2771 7098 ext 129	castro.gabriel@aeonastron.net

Locations


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

Sponsors and Collaborators

Pro Top & Mediking Company Limited

Investigators


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

More Information

The product information of OculusGen This link exits the ClinicalTrials.gov site

Publications of Results:

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. 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 ID Numbers:	Mediking 0702, OculusGen-2006-03-20
First Received:	March 15, 2007
Last Updated:	May 28, 2008
ClinicalTrials.gov Identifier:	NCT00448929
Health Authority:	India: Indian Council of Medical Research

Keywords provided by Pro Top & Mediking Company Limited:

Glaucoma

Collagen matrix

ologen

OculusGen

Trabeculectomy

tissue enginnering

Study placed in the following topic categories:

Glaucoma

Eye Diseases

Hypertension

Ocular Hypertension

ClinicalTrials.gov processed this record on October 31, 2008

Sponsored by:	Pro Top & Mediking Company Limited
Information provided by:	Pro Top & Mediking Company Limited
ClinicalTrials.gov Identifier:	NCT00448929