Bevacizumab Versus Mitomycin C as Trabeculectomy Adjuvant in Uncontrolled Glaucoma

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

January 31, 2014

Primary Completion Date

January 31, 2015

Study Completion Date

January 31, 2016

Conditions
Glaucoma
Interventions
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.

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.

DRUG

Bevacizumab

After conjunctival closure 1.25mg of bevacizumab will be injected into the anterior chamber through a paracentesis created earlier during the case.

All Listed Sponsors
lead

Athens Vision Eye Institute

OTHER

NCT02901236 - Bevacizumab Versus Mitomycin C as Trabeculectomy Adjuvant in Uncontrolled Glaucoma | Biotech Hunter | Biotech Hunter