Lucentis Versus Mitomycin C During Glaucoma Surgery

Wills Eye

Status and phase: Completed; Phase 3; Phase 2

Conditions: Glaucoma

Treatments: Drug: Mitomycin (MMC); Drug: Ranibizumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00626782

IRB#07-819

rhuFAB v2 (Other Grant/Funding Number)

Details and patient eligibility

About

Does a new add on (or adjunctive) therapy used in glaucoma surgery improve the success of trabeculectomy? Ranibizumab may offer benefit similar to mitomycin C in preventing epi-scleral fibrosis while avoiding the well known complications of mytomycin C which include late bleb leaks, hypotony and infection.

Full description

This is an open-label, single center trial with two arms for patients who underwent guarded filtration surgery to control glaucoma. The control will consist of patients randomly assigned to receive inter-operative mitomycin C 0.4 mg/ml which is applied in a standard fashion with a soaked pledget inserted in the sub-tenon's space during surgery. The study arm will consist of patients randomly assigned to receive a sub-tenon injection of Ranibizumab 0.5 mg/0.05mL with a 30 gauge needle on a tuberculin syringe at the termination of the surgery. No mitomycin C will be applied.

Post operative follow-up will consist of a minimum of 6 visits during a one year period.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 yrs or older
• patients requiring first time glaucoma filtering surgery
• phakic or pseudophakic
• must provide written informed consent and comply with study assignments

Exclusion criteria

• Pregnant, lactation or premenopausal women not using adequate contraception.
• Previous glaucoma surgery, tube shunt surgery, pars plana vitrectomy, scleral buckle, penetrating keratoplasty.
• Abnormality preventing reliable applanation tonometry in each eye.
• Current infection or inflammation in either eye.
• Enrolled in another investigational study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

24 participants in 2 patient groups

A: Ranibizumab 0.5mg (0.05mL) injection

Experimental group

Description:

Ranibizumab 0.5mg (0.05mL) injection at end of trabeculectomy surgery. This intra-operative adjunct therapy was administered sub-conjunctivally 8-10mm posteriorly to the limbus as an antifibrotic agent.

Treatment:

Drug: Ranibizumab

B: Mitomycin C 0.4 mg/ml sponge

Active Comparator group

Description:

Mitomycin C 0.4 mg/ml soaked sponge applied to sclera (for up to 2 min) after flap is made during trabeculectomy surgery. This is the typical method used as an antifibrotic agent.

Treatment:

Drug: Mitomycin (MMC)