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OpenTrials
Completed

NCT Number: NCT00626782

Lucentis Versus Mitomycin C During Glaucoma Surgery

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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Wills Eye Hospital, Glaucoma Service

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ranibizumab

Drug

Ranibizumab 0.5mg (0.05mL)one injection in sub-tenon's at the conclusion of glaucoma surgery

Other names: Lucentis

Mitomycin (MMC)

Drug

Mitomycin (MMC) C 0.4 mg/ml applied with soaked pledget inserted in the sub-tenon's space during glaucoma surgery.

Other names: MMC C 0.4 mg/ml

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Wills Eye

Other

Collaborators

  • Genentech, Inc.
  • Novartis Pharmaceuticals

Registry information

Official study title

Lucentis Versus Mitomycin C as Adjunctive Agent During Trabeculectomy Surgery

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Feb 29, 2008
Registry last updated
Mar 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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