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5FU vs 5FU With Viscoelastic Formulation for the Prevention of Scarring Post-trabeculectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00607685
First Posted: February 6, 2008
Last Update Posted: May 12, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Singapore Eye Research Institute
Nanchang University
Information provided by:
Singapore National Eye Centre
  Purpose

Trabeculectomy is the most effective method of lowering intraocular pressure in glaucoma that is not well controlled with drop medication. The post-operative wound healing response remains the major barrier in surgical success. Scar tissue formation results in occlusion of the surgical drainage site created. As a consequence, the intraocular pressure rises once again. The current use of anti-scarring agents such as 5 Fluorouracil (5FU), is a well established method employed by ophthalmologists to clinically reduce the postoperative scarring response. However, in patients with a high risk of bleb failure, repeated subconjunctival injections of 5FU following bleb needling is often required resulting in increased clinical load and patient inconvenience. A slow release formulation of 5FU would be of benefit by releasing the 5FU into the subconjunctival space over an extended period thereby providing a prolonged therapeutic effect. In addition, hyaluronic acid is known to possess antifibrotic properties and from its gel-like physical state, would potentially act as a physical tissue spacer that may further limit active subconjunctival scarring at the site where it is injected. We hypothesise that injecting a mixture of 5FU with hyaluronic acid would give better outcomes than injecting 5FU alone.

The aim of this study is to determine whether bleb needling with subconjunctival injection of Viscoelastic/5FU formulation is an effective method for prolonged drug delivery in preventing the post-operative scarring response. This will be a prospective case-controlled study involving patients who have already undergone trabeculectomy and who require bleb needling and subconjunctival 5FU injections.


Condition Intervention Phase
Glaucoma Trabeculectomy Wound Healing Drug: 5 Fluorouracil with hyaluronic acid Drug: 5 Fluorouracil Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Case-controlled Study Comparing 5-Fluorouracil vs 5-Fluorouracil With Viscoelastic (Hyaluronic Acid) Formulation for the Prevention of Subconjunctival Scarring Post-trabeculectomy

Resource links provided by NLM:


Further study details as provided by Singapore National Eye Centre:

Primary Outcome Measures:
  • intraocular pressure [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • bleb morphology [ Time Frame: 12 weeks ]

Estimated Enrollment: 50
Study Start Date: February 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
The participants will receive a subconjunctival injection of a mixture of 5FU with hyaluronic acid.
Drug: 5 Fluorouracil with hyaluronic acid
Participants will receive a subconjunctival injection of 0.1ml of a mixure of 5 Fluorouracil (50mg/ml) with hyaluronic acid (23mg/ml) once at enrollment into the study.
Other Name: Healon 5 - hyaluronic acid 23mg/ml
Active Comparator: 2
Participants will receive a subconjunctival injection of 5 Fluorouracil only.
Drug: 5 Fluorouracil
Pariticpants will receive a subconjunctival injection of 0.1ml of 5 Fluorouracil 50mg/ml once at enrollment

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Glaucoma patients within 1 year of the primary (first) trabeculectomy who are deemed on clinical grounds (increased bleb vascularity, bleb contraction or encapsulation or IOP elevation) to require a subconjunctival 5-FU injection.

Exclusion Criteria:

  1. Active or recent bleb leak
  2. Known hypersensitivity to 5-FU or HA
  3. Only eye
  4. Active or recent blebitis or endophthalmitis.
  5. Intraocular pressure less than 10.
  6. Inability to give informed consent.
  7. Inability to safely administer a subconjunctival injection
  8. Uncontrolled systemic hypertension, CVA or TIA within the previous month.
  9. Pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00607685


Locations
Singapore
Singapore National Eye Centre
Singapore, Singapore, 168751
Sponsors and Collaborators
Singapore National Eye Centre
Singapore Eye Research Institute
Nanchang University
Investigators
Study Chair: Tina TL Wong, PhD Singapore National Eye Centre
  More Information

Responsible Party: Dr Tina Wong, Singapore National Eye Centre
ClinicalTrials.gov Identifier: NCT00607685     History of Changes
Other Study ID Numbers: R554/42/2007
First Submitted: January 23, 2008
First Posted: February 6, 2008
Last Update Posted: May 12, 2010
Last Verified: May 2010

Keywords provided by Singapore National Eye Centre:
Trabeculectomy
Wound healing
5 Fluorouracil
Hyaluronic acid
post-operative scarring

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes
Fluorouracil
Hyaluronic Acid
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Viscosupplements
Protective Agents