Ologen (OculusGen)-Glaucoma MMC Control Trial in India

Study Overview
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Brief Summary
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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
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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. 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. 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.

Official Title
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Comparative Study of the Safety and Effectiveness Between Ologen (OculusGen) Collagen Matrix Implant and Mitomycin-C in Glaucoma Filtering Surgery

Conditions
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Glaucoma

Intervention / Treatment
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* Device: OculusGen Biodegradable Collagen Matrix Implant
* Drug: Trabeculectomy with MMC


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OculusGen Biodegradable Collagen Matrix Implant<br>Trabeculectomy with OculusGen Biodegradable Collagen Matrix Implant | Device: OculusGen Biodegradable Collagen Matrix Implant<br>* Trabeculectomy with OculusGen Biodegradable Collagen Matrix Implant<br>|
| Active Comparator: MMC<br>Trabeculectomy with MMC | Drug: Trabeculectomy with MMC<br>* Trabeculectomy with MMC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the effectiveness via the reduction of IOP |  | 180 day | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glaucoma, Collagen matrix, ologen, OculusGen, Trabeculectomy, anti scarring, tissue engineering, high risk patient for trabeculectomy, Aeon Astron