Trabeculectomy With Mitomycin C Associated With Sub-conjunctival Injection of Ranibizumab
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Trabeculectomy with mitomycin C remains the standard surgery for glaucoma. This surgery involves creating a door in the eye wall in order to improve fluid outflow and decrease intraocular pressure. However, success rates range from 70% to 90% depending on the criteria used and tend to decrease with time. The failure of the surgery is associated with inflammation, new blood vessel formation and scarring which can cause closure of the door. Molecules which inhibit new blood vessel formation such as inhibitors of vascular endothelial growth factor have been used successfully to decrease scarring in animal eyes where little doors were created and significantly improve survival. Furthermore, they have shown promise when used during trabeculectomy. Ranibizumab, a vascular endothelial growth factor, has also been used safely in intraocular surgery to treat other diseases which involve new blood vessel formation such as macular degeneration and diabetes.
The investigators hypothesize that ranibizumab may decrease the failure rate of trabeculectomy with mitomycin C by decreasing scarring.
The aim of the study is to evaluate the difference in failure rates and bleb morphology at one year post-operatively in eyes having undergone sub-conjunctival injections of ranibizumab in addition to primary trabeculectomy with mitomycin C compared to eyes having undergone trabeculectomy with mitomycin C alone.
| Condition | Intervention |
|---|---|
|
Glaucoma |
Drug: ranibizumab Procedure: standard care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Trabeculectomy With Mitomycin C Associated With Sub-conjunctival Injection of Ranibizumab |
- Failure rates of the surgery as defined by intraocular pressure reductions [ Time Frame: one year ] [ Designated as safety issue: No ]
- Bleb morphology using Moorfields bleb grading system [ Time Frame: one year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 240 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ranibizumab
Trabeculectomy with mitomycin C associated with 2 subconjunctival injections of ranibizumab: 1 intraoperatively and 1 at 2 weeks post-operatively
|
Drug: ranibizumab
Two ranibizumab subconjunctival injections (0.5 mg ∕ 0.05 mL). The first injection at the end of the surgery (intraoperative) and the second two weeks post-operatively.
|
|
Active Comparator: standard care
Trabeculectomy with mitomycin C and standard post-operative care
|
Procedure: standard care
standard post-operative care after trabeculectomy with mitomycin C
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- to have uncontrolled glaucoma
- to have accepted to undergo a primary trabeculectomy with mitomycin C
to have one of the following types of glaucoma:
- Normal tension Glaucoma
- Chronic Open-Angle Glaucoma
- Chronic Angle-Closure Glaucoma
- Mixed mechanism glaucoma
- Steroid-induced Glaucoma
- Neovascular Glaucoma
Exclusion Criteria:
- to be less than 18 years old
- to be unable to observe the study protocol
- to present some risk factors for thromboembolic events and cerebrovascular accidents : hypertension, dyslipidemia, coronary artery diseases
- a history of thromboembolic events and cerebrovascular accidents
- congenital glaucoma
- uveitic glaucoma
- to be pregnant
- to be breastfeeding
- surgical complications prior to injection of the study drug such as vitreous in the anterior chamber or the presence of suprachoroidal hemorrhages
- to have undergone a previous conjunctival surgery
- to be hypersensitive to the drug, to one of the components of the drug or to one of the components of the packaging
- to present an active or suspected intraocular or periocular inflammation
- to have a kidney failure
- to have a liver failure
Contacts and Locations| Canada, Quebec | |
| Maisonneuve-Rosemont Hospital | |
| Montreal, Quebec, Canada, H1T2M4 | |
| Principal Investigator: | Gisele Li, M.D. | Maisonneuve-Rosemont Hospital |
More Information
No publications provided
| Responsible Party: | Gisele Li, Assistant Professor, Maisonneuve-Rosemont Hospital |
| ClinicalTrials.gov Identifier: | NCT00892398 History of Changes |
| Other Study ID Numbers: | CRFB002ACA04T |
| Study First Received: | May 1, 2009 |
| Last Updated: | October 22, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Maisonneuve-Rosemont Hospital:
|
Trabeculectomy Vascular Endothelial Growth Factor A Wound Healing Angiogenesis Inhibitors |
Additional relevant MeSH terms:
|
Glaucoma Ocular Hypertension Eye Diseases Mitomycins Mitomycin Angiogenesis Inhibitors Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Alkylating Agents Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013