Lucentis Versus Mitomycin C During Glaucoma Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00626782|
Recruitment Status : Completed
First Posted : February 29, 2008
Results First Posted : March 13, 2015
Last Update Posted : March 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma||Drug: Ranibizumab Drug: Mitomycin (MMC)||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Patients requiring trabeculectomy were randomly assigned to either MMC or Ranibizumab during surgery.|
|Masking:||None (Open Label)|
|Official Title:||Lucentis Versus Mitomycin C as Adjunctive Agent During Trabeculectomy Surgery|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||April 2011|
Experimental: A: Ranibizumab 0.5mg (0.05mL) injection
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.
Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery
Other Name: Lucentis
Active Comparator: B: Mitomycin C 0.4 mg/ml sponge
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.
Drug: Mitomycin (MMC)
Mitomycin (MMC) C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery.
Other Name: MMC C 0.4 mg/ml
- Adverse Events [ Time Frame: 12 months ]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.
- Post-Operative Requirement for Glaucoma Medication [ Time Frame: 1 day, 2 wks, 1, 3, 6 and 12 months ]Mean number of glaucoma medications used by each participant over the course of one year post-operatively.
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): NCT00626782
|United States, Pennsylvania|
|Wills Eye Hospital, Glaucoma Service|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Michael J Pro, MD||Wills Eye Institute|