Ologen (OculusGen)-Glaucoma MMC Control in Pakistan

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 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, Trabeculectomy

Intervention / Treatment
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* Device: ologen collagen matrix in glaucoma filtering surgery
* Drug: MMC in glaucoma filtering surgery


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 Bovine 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: 1<br>20 patients will be recruited according to the enrollment acceptance criteria.Randomisation is performed using a sealed envelope system, where 40 shuffled envelopes designating the surgery to either trabeculectomy with mitomycin-C (MMC) and trabeculectomy with ologen™ Collagen matrix must be open before surgery. Then, patients are allocated and trabeculectomy is performed.If ologen™ treatment is used, the collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy. | Device: ologen collagen matrix in glaucoma filtering surgery<br>* If ologen™ treatment is used, the collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.<br>|
| Active Comparator: 2<br>Following ethics committee approval, 20 patients with uncontrolled glaucoma will be randomised to trabeculectomy with mitomycin -C. Randomisation is performed. Then, trabeculectomy is performed | Drug: MMC in glaucoma filtering surgery<br>* If mitomycin -C is applied, a single cellulose sponge soaked with MMC (0.2mg/ml - 0.4mg/ml) is fashioned into an approximate 2.0 × 4.0 mm rectangular shape and applied to the scleral bed and subconjunctival space taking care to avoid exposure to the conjunctival wound edge. Application time is 2 minutes for MMC. Then, the area treated is copiously irrigated with balanced salt solution. After operation, appropriate anti-inflammatory and antibiotic eye-drops will be prescribed.<br>* Other names: Mitomycin C;|

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, Antifibrotic, Trabeculectomy, anti scarring, tissue engineering, high risk patient for trabeculectomy, Aeon Astron