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

NCT00607685 | Completed Phase 4

• 1 other identifier: R554/42/2007
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glaucoma; Trabeculectomy; Wound Healing

Keywords

Trabeculectomy; Wound healing; 5 Fluorouracil; Hyaluronic acid; post-operative scarring

Outcome Measures

Primary Outcomes (1)

• intraocular pressure

  12 weeks

Secondary Outcomes (1)

• bleb morphology

  12 weeks

Study Arms (2)

1

EXPERIMENTAL

The participants will receive a subconjunctival injection of a mixture of 5FU with hyaluronic acid.

Drug: 5 Fluorouracil with hyaluronic acid

2

ACTIVE COMPARATOR

Participants will receive a subconjunctival injection of 5 Fluorouracil only.

Drug: 5 Fluorouracil

Interventions

5 Fluorouracil with hyaluronic acid DRUG

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.

Also known as: Healon 5 - hyaluronic acid 23mg/ml

1

5 Fluorouracil DRUG

Pariticpants will receive a subconjunctival injection of 0.1ml of 5 Fluorouracil 50mg/ml once at enrollment

2

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Active or recent bleb leak
• Known hypersensitivity to 5-FU or HA
• Only eye
• Active or recent blebitis or endophthalmitis.
• Intraocular pressure less than 10.
• Inability to give informed consent.
• Inability to safely administer a subconjunctival injection
• Uncontrolled systemic hypertension, CVA or TIA within the previous month.
• Pregnancy

Sponsors & Collaborators

• Singapore National Eye Centre: lead
• Singapore Eye Research Institute: collaborator
• Nanchang University: collaborator

Study Sites (1)

Singapore National Eye Centre

Singapore, 168751, Singapore

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Fluorouracil; Hyaluronic Acid

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Tina TL Wong, PhD

  Singapore National Eye Centre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: January 23, 2008
• First Posted: February 6, 2008
• Study Start: February 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: May 12, 2010

Record last verified: 2010-05

Locations

SG (1)