Clinical trial NCT00449098: Ologen (OculusGen)-Glaucoma MMC Control Trial in India
Official title: Comparative Study of the Safety and Effectiveness Between Ologen (OculusGen) Collagen Matrix Implant and Mitomycin-C in Glaucoma Filtering Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Glaucoma
Keywords: Glaucoma
Collagen matrix
ologen
OculusGen
Trabeculectomy
anti scarring
tissue engineering
high risk patient for trabeculectomy
Aeon Astron
Lead sponsor: Pro Top & Mediking Company Limited
Sponsor class: INDUSTRY
First posted: 2007-03-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
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 the ologen (OculusGen) Biodegradable Collagen Matrix Implant and the MMC group in filtration surgery.

Detailed description: 1. Study Objective: To compare the safety and effectiveness of the ologen (OculusGen) Biodegradable Collagen Matrix Implant and the MMC group 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 ologen (OculusGen) implant or trabeculectomy with mitomycin-C.
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 18 years or over.
* 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 mitomycin-C or porcine collagen.
* Subject is on warfarin and discontinuation is not recommended.
* Normal tension glaucoma.
* Participation in an investigational study during the 30 days preceding 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: Rajul S Parikh, 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.