Use of Ranibizumab With Mitomycin C During Trabeculectomy - Full Text View

Sponsors and Collaborators:	University of Colorado at Denver and Health Sciences Center Genentech
Information provided by:	University of Colorado at Denver and Health Sciences Center
ClinicalTrials.gov Identifier:	NCT00661583

Purpose

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 function of the bleb. This study will add ranibizumab to the standard of care treatment as ranibizumab may compliment mitomycin C in the prevention of scarring at the bleb site potentially adding to the effectiveness of mitomycin C.

The study will access ocular adverse events of adding ranibizumab to standard of care treatment at 6 months after trabeculectomy.

Condition	Intervention
Trabeculectomy Glaucoma	Drug: ranibizumab

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

Drug Information available for: Ranibizumab Mitomycin Mitomycins

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	OCclusion Prevention for TrabeculectOmy Procedures Using Combination Ranibizumab and Mitomycin C (MMC) During Surgery (OCTOPUS Study)

Further study details as provided by University of Colorado at Denver and Health Sciences Center:

Primary Outcome Measures:

to assess ocular adverse events of combination ranibizumab and MMC therapy at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

to determine percent of subjects with a qualified success and viable bleb at 6 months (IOP between 6mm Hg and 22 mm Hg with pressure controlled with and without adjunctive medications) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
to determine mean change in in intraocular pressure and in visual acuity at 3 months and at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	April 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator standard of care	Drug: ranibizumab 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661583

Contacts

Contact: Malik Y. Kahook, MD	720-848-5029	malik.kahook@uchsc.edu
Contact: Tim Byrne	720-848-5051	tim.byrne@uchsc.edu

Locations

United States, Colorado
Rocky Mountain Lions Eye Institute	Recruiting
Aurora, Colorado, United States, 80045
Contact: Malik Y. Kahook, MD 720-848-5029 malik.kahook@uchsc.edu
Contact: Tim Byrne 720-848-5051 tim.byrne@uchsc.edu
Sub-Investigator: Douglas L. MacKenzie, MD

Sponsors and Collaborators

University of Colorado at Denver and Health Sciences Center

Genentech

Investigators

Study Director:

Malik Y. Kahook, MD

Rocky Mountain Lions Eye institute

More Information

Responsible Party:	University of Colorado Health Sciences Center ( Malik Kahook, MD )
Study ID Numbers:	myk07-0921
Study First Received:	April 15, 2008
Last Updated:	April 17, 2008
ClinicalTrials.gov Identifier:	NCT00661583
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Colorado at Denver and Health Sciences Center:

trabeculectomy
glaucoma
ranibizumab

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Mitomycin

Mitomycins
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors

Antibiotics, Antineoplastic
Alkylating Agents
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009