Lucentis Versus Mitomycin C During Glaucoma Surgery

Glaucoma Clinical Trial

Official title:

Lucentis Versus Mitomycin C as Adjunctive Agent During Trabeculectomy Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00626782
• Other study ID #: IRB#07-819
• Secondary ID: rhuFAB v2
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 20, 2008
• Last updated: February 23, 2018
• Start date: January 2008
• Est. completion date: April 2011

Study information

• Verified date: February 2018
• Source: Wills Eye
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma

Intervention

Drug:
• Ranibizumab
Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery
• Mitomycin (MMC)
Mitomycin (MMC) C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery.

Locations

Country	Name	City	State
United States	Wills Eye Hospital, Glaucoma Service	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Wills Eye	Genentech, Inc., Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (2)

Pro MJ, Freidl KB, Neylan CJ, Sawchyn AK, Wizov SS, Moster MR. Ranibizumab versus mitomycin C in primary trabeculectomy--a pilot study. Curr Eye Res. 2015 May;40(5):510-5. doi: 10.3109/02713683.2014.935441. Epub 2014 Jul 14. — View Citation

Pro, MJ, Sawchyn AK, Ichhpujani P, Wizov S, Moster MR, Spaeth GL. Intraoperative Ranibizumab versus Mitomycin-C in Primary Trabeculectomy - A Pilot Study. ARVO E-abstract 619/A463 2010.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Percentage of participants with ocular adverse events and other adverse events as identified by eye examination, physical examination, subject reporting and changes in vital signs one year post-operatively.	12 months
Secondary	Post-Operative Requirement for Glaucoma Medication	Mean number of glaucoma medications used by each participant over the course of one year post-operatively.	1 day, 2 wks, 1, 3, 6 and 12 months