Ologen (OculusGen)-Glaucoma MMC Control in Pakistan

Pro Top & Mediking

Status and phase: Completed; Phase 3

Conditions: Trabeculectomy; Glaucoma

Treatments: Drug: MMC in glaucoma filtering surgery; Device: ologen collagen matrix in glaucoma filtering surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT00472810

OculusGen-2006-02-20

Mediking 0703

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 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 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 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.

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

1

Experimental group

Description:

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.

Treatment:

Device: ologen collagen matrix in glaucoma filtering surgery

2

Active Comparator group

Description:

Following ethics committee approval, 20 patients with uncontrolled glaucoma will be randomised to trabeculectomy with mitomycin -C. Randomisation is performed. Then, trabeculectomy is performed

Treatment:

Drug: MMC in glaucoma filtering surgery