Clinical trial NCT00448929: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma
Keywords: Glaucoma
Collagen matrix
ologen
OculusGen
Trabeculectomy
Lead sponsor: Pro Top & Mediking Company Limited
Sponsor class: INDUSTRY
First posted: 2007-03-19
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: the effectiveness via the reduction of IOP
timeFrame: 180 day
Secondary outcomes:
measure: the safety via the incidence of complications and adverse events.
timeFrame: 180 day
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: L. V. Prasad Eye Institute
state: Andhra Prades
Study officials:
affiliation: V. S. T. Glaucoma Services, L. V. Prasad Eye Institute,
name: Anil Mandal, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.