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Bevacizumab Versus Mitomycin C as Trabeculectomy Adjuvant in Uncontrolled Glaucoma (AvastinvsMMC)

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ClinicalTrials.gov Identifier: NCT02901236
Recruitment Status : Completed
First Posted : September 15, 2016
Last Update Posted : September 15, 2016
Sponsor:
Information provided by (Responsible Party):
Theodoros Filippopoulos, Athens Vision Eye Institute

Brief Summary:
Refractory glaucoma often requires vision-sparing trabeculectomy. To increase surgical success, adjunctive pharmacotherapy is utilized albeit the risk of adverse events. This prospective trial randomizes adults with uncontrolled glaucoma to assess an emerging healing modulatory strategy. Over a 1-year follow-up, trabeculectomy complemented with intracameral delivery of anti-angiogenic bevacizumab (1.25 mg) is compared to standard trabeculectomy with anti-fibrotic mitomycin-C (0.02%; applied for 2 minutes).

Condition or disease Intervention/treatment Phase
Glaucoma Procedure: Standard Guarded Trabeculectomy Drug: Mitomycin C Drug: Bevacizumab Phase 2 Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bevacizumab Versus Mitomycin C as Trabeculectomy Adjuvant in Uncontrolled Glaucoma: A Randomized Pilot Trial.
Study Start Date : January 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Active Comparator: Mitomycin C
Standard Guarded Trabeculectomy will be performed. In this arm 0.02% of mitomycin C (Kyowa, Japan) will be applied on bare sclera under the conjunctiva for 2 minutes. Subsequently, the area will be copiously irrigated with balanced salt solution.
Procedure: Standard Guarded Trabeculectomy
A fornix based conjunctival peritomy is performed. A partial thickness scleral flap is dissected. Then trabeculectomy is performed with a Kelly's punch. A surgical iridectomy is performed. The scleral flap is secured with two pre-placed 8-0 Vicryl sutures (Ethicon, Somerville, NJ). The anterior chamber (AC) is inflated with balanced salt solution and suture tension is adjusted. Finally, conjunctiva is closed with 10-0 running Nylon sutures (Ethicon, Somerville, NJ). Patients receive a subconjunctival injection of 0.4 ml dexamethasone (4 mg/ml) and of 0.4 ml gentamicin (40 mg/ml) at the end of the case. Adjuvant pharmacologic treatment to prevent episcleral fibrosis and failure of the procedure is applied according to treatment arm assignment.
Other Names:
  • trabeculectomy
  • glaucoma filtration surgery
  • trabeculectomy with antimetabolites
  • trabeculectomy with antifibrotic agents

Drug: Mitomycin C
Sponges soaked in 0.02% mitomycin C (MMC) will be applied on bare sclera for 2 minutes. Subsequently, the area will be copiously irrigated with balanced salt solution.
Other Name: MMC

Active Comparator: Bevacizumab
Standard Guarded Trabeculectomy will be performed. In this arm at the end of the case and after conjunctival closure 1.25mg of bevacizumab (Avastin; Genentech, San Francisco, CA) will be injected into the the anterior chamber through a paracentesis.
Procedure: Standard Guarded Trabeculectomy
A fornix based conjunctival peritomy is performed. A partial thickness scleral flap is dissected. Then trabeculectomy is performed with a Kelly's punch. A surgical iridectomy is performed. The scleral flap is secured with two pre-placed 8-0 Vicryl sutures (Ethicon, Somerville, NJ). The anterior chamber (AC) is inflated with balanced salt solution and suture tension is adjusted. Finally, conjunctiva is closed with 10-0 running Nylon sutures (Ethicon, Somerville, NJ). Patients receive a subconjunctival injection of 0.4 ml dexamethasone (4 mg/ml) and of 0.4 ml gentamicin (40 mg/ml) at the end of the case. Adjuvant pharmacologic treatment to prevent episcleral fibrosis and failure of the procedure is applied according to treatment arm assignment.
Other Names:
  • trabeculectomy
  • glaucoma filtration surgery
  • trabeculectomy with antimetabolites
  • trabeculectomy with antifibrotic agents

Drug: Bevacizumab
After conjunctival closure 1.25mg of bevacizumab will be injected into the anterior chamber through a paracentesis created earlier during the case.
Other Name: Avastin




Primary Outcome Measures :
  1. Intraocular Pressure [ Time Frame: 1 year after the intervention ]
    Intraocular pressure measured by Goldmann applanation tonometry was declared the primary outcome measure


Secondary Outcome Measures :
  1. Rate of Surgical Success (Survival of Surgical Procedure) [ Time Frame: 1 year after the intervention ]
    Tube Versus Trabeculectomy (TVT) study criteria are used to define complete surgical success (i.e., intraocular pressure > 5 mmHg and < 21 mmHg in conjunction with at least 20% reduction in intraocular pressure without medications, no re-operation for glaucoma and maintained light perception).26 Qualified success referred to success with glaucoma medications.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients
  • primary or secondary open angle or angle closure glaucoma
  • preoperative intraocular pressure > 21 mmHg on maximally tolerated medical therapy at least on 2 occasions prior to randomization
  • ability to attend regular follow-up

Exclusion Criteria:

  • age (< 18 years)
  • pregnancy
  • severe ocular surface disease
  • need for combined phacotrabeculectomy
  • uveitic or neovascular glaucoma
  • any prior intraocular surgery except for uncomplicated phacoemulsification
  • a history of a systemic thromboembolic event within 6 months before surgery

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): NCT02901236


Sponsors and Collaborators
Athens Vision Eye Institute
Investigators
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Principal Investigator: Gerassimos Kopsinis, M.D., Ph.D. Athens Vision Eye Institute

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Responsible Party: Theodoros Filippopoulos, Director of the Glaucoma Service, Athens Vision Eye Institute
ClinicalTrials.gov Identifier: NCT02901236     History of Changes
Other Study ID Numbers: Gl001
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Result will be submitted for publication to a peer review journal as soon as they become available. They will also be presented at national and international meetings.

Keywords provided by Theodoros Filippopoulos, Athens Vision Eye Institute:
trabeculectomy
glaucoma
filtration surgery
wound healing
angiogenesis
mitomycin
vascular endothelial growth factor inhibition

Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases
Bevacizumab
Mitomycins
Mitomycin
Antimetabolites
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antibiotics, Antineoplastic
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors