Ologen (OculusGen)-Glaucoma MMC Control Trial in India

Pro Top & Mediking

Status and phase: Unknown; Phase 4

Conditions: Glaucoma

Treatments: Device: OculusGen Biodegradable Collagen Matrix Implant; Drug: Trabeculectomy with MMC

Study type: Interventional

Funder types: Industry

Identifiers

NCT00449098

OculusGen-2006-02-20

Mediking 0701

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

OculusGen Biodegradable Collagen Matrix Implant

Experimental group

Description:

Trabeculectomy with OculusGen Biodegradable Collagen Matrix Implant

Treatment:

Device: OculusGen Biodegradable Collagen Matrix Implant

MMC

Active Comparator group

Description:

Trabeculectomy with MMC

Treatment:

Drug: Trabeculectomy with MMC