Ologen (OculusGen)-Glaucoma MMC Control in Pakistan

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pro Top & Mediking Company Limited
ClinicalTrials.gov Identifier:
NCT00472810
First received: May 11, 2007
Last updated: October 6, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Glaucoma
Trabeculectomy
Device: ologen collagen matrix in glaucoma filtering surgery
Drug: MMC in glaucoma filtering surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparative Study of the Safety and Effectiveness Between Ologen (OculusGen) Collagen Matrix Implant and Mitomycin-C in Glaucoma Filtering Surgery

Resource links provided by NLM:


Further study details as provided by Pro Top & Mediking Company Limited:

Primary Outcome Measures:
  • the effectiveness via the reduction of IOP [ Time Frame: 180 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the safety via the incidence of complications and adverse events. [ Time Frame: 180 day ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: March 2007
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
If ologen™ treatment is used, the collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
Active Comparator: 2
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
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.
Other Name: Mitomycin C

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 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00472810

Locations
Pakistan
RMC & Allied Hospital
Rawalpindi, Punjab, Pakistan
Sponsors and Collaborators
Pro Top & Mediking Company Limited
Investigators
Principal Investigator: Syed Imtiaz Ali, Professor RMC & Allied Hospital
  More Information

Publications:
Responsible Party: Pro Top & Mediking Company Limited
ClinicalTrials.gov Identifier: NCT00472810     History of Changes
Other Study ID Numbers: Mediking 0703, OculusGen-2006-02-20
Study First Received: May 11, 2007
Last Updated: October 6, 2011
Health Authority: Pakistan: Ministry of Health. Pakistani secretariat, Lahore Punjab Pakistan.

Keywords provided by Pro Top & Mediking Company Limited:
Glaucoma
Collagen matrix
ologen
OculusGen
Antifibrotic
Trabeculectomy
anti scarring
tissue engineering
high risk patient for trabeculectomy
Aeon Astron

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014