Bevacizumab Versus Mitomycin C as Trabeculectomy Adjuvant in Uncontrolled Glaucoma

Sponsor
Athens Vision Eye Institute
Study ID
NCT02901236
Phase
PHASE2/PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Standard Guarded Trabeculectomy — PROCEDURE
    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.
  • Mitomycin C — DRUG
    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.
  • Bevacizumab — DRUG
    After conjunctival closure 1.25mg of bevacizumab will be injected into the anterior chamber through a paracentesis created earlier during the case.

Study Details

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).

Key Dates

First listed
Sep 15, 2016
Start date
Jan 31, 2014
Status verified
Sep 2016
Primary completion
Jan 31, 2015
Completion
Jan 31, 2016

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Intraocular Pressure [ Time Frame: 1 year after the intervention ]

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