Use of Ranibizumab With Mitomycin C During Trabeculectomy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2014-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the study is to study the safety of the combination of ranibizumab and MMC vs monotherapy MMC vs intravitreal ranibizumab injection in patients with glaucoma.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Lucentis Versus Mitomycin C During Glaucoma Surgery

NCT00626782

Glaucoma

COMPLETED PHASE2/PHASE3

Trabeculectomy With Mitomycin C Associated With Sub-conjunctival Injection of Ranibizumab

NCT00892398

Glaucoma

COMPLETED NA

Ranibizumab for the Inhibition of Neovascularization in the Cornea Following Corneal Transplant Surgery

NCT00769145

Corneal Neovascularization

COMPLETED PHASE1

Treatment of Failing Blebs With Ranibizumab

NCT00570726

Glaucoma, Open-Angle Failing Bleb Following Trabeculectomy

COMPLETED PHASE1

Ranibizumab Therapy for Non-arteritic Ischemic Optic Neuropathy

NCT00561834

Nonarteritic Anterior Ischemic Optic Neuropathy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A common problem after undergoing trabeculectomy surgery to create a bleb (blister or bubble) to reduce intraocular pressure, is scarring of the opening. This scarring prevents fluid drainage and interferes with the proper functioning of the bleb. MMC (Mitomycin C) is usually administered intraoperatively, to reduce scarring and increase filtration. However, the failure rate of trabeculectomy remains high. Anti-VEGF (Vascular endothelial growth factor) agents have been used successfully in cases requiring bleb needling. The purpose of the study is to determine the safety of the combination of ranibizumab and MMC vs monotherapy MMC in patients with glaucoma.

This is an open-label, Phase I/II safety study of 30 patients randomized to either treatment with ranibizumab 0.5 mg intravitreally injected (n=10), combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10) or MMC therapy alone (n=10).

For the ranibizumab groups, a repeat injection of ranibizumab 0.5mg may be given PRN (as needed) at 1 month if hypervascularity or neovascularization of the conjunctiva exists.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glaucoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ranibizumab alone

Treatment with ranibizumab 0.5 mg intravitreally injected (n=10)

Group Type EXPERIMENTAL

Ranibizumab

Intervention Type DRUG

0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed

Ranibizumab and MMC

Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)

Group Type EXPERIMENTAL

Ranibizumab and MMC

Intervention Type DRUG

Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy

MMC alone

MMC therapy alone (n=10)

Group Type ACTIVE_COMPARATOR

MMC

Intervention Type DRUG

MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ranibizumab

0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed

Intervention Type DRUG

Ranibizumab and MMC

Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy

Intervention Type DRUG

MMC

MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ranibizumab and Mitomycin C Mitomycin C

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* glaucoma
* undergoing trabeculectomy
* 21 years of age or older

Exclusion Criteria

* pregnancy or lactation
* any condition the investigator believes would impose a significant hazard to the patient if investigational therapy were initiated
* history of ocular surface disease
* cataract surgery in the past 6 months
* history of active inflammatory, infectious or idiopathic keratitis

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No