NCT00661583

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2008

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 18, 2008

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

October 13, 2016

Completed
Last Updated

October 13, 2016

Status Verified

August 1, 2016

Enrollment Period

6.4 years

First QC Date

April 15, 2008

Results QC Date

July 1, 2016

Last Update Submit

August 19, 2016

Conditions

Glaucoma

Keywords

trabeculectomyglaucomaranibizumab

Outcome Measures

Primary Outcomes (1)

  • Assessment of Ocular Adverse Events

    To assess ocular adverse events of combination ranibizumab and MMC therapy at 6 months

    6 months

Secondary Outcomes (3)

  • Percent of Subjects With a Qualified Success and Viable Bleb at 6 Months.

    6 months

  • Mean Change in in Intraocular Pressure.

    6 months

  • Mean Change in Visual Acuity

    6 months

Study Arms (3)

Ranibizumab alone

EXPERIMENTAL

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

Drug: Ranibizumab

Ranibizumab and MMC

EXPERIMENTAL

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

Drug: Ranibizumab and MMC

MMC alone

ACTIVE COMPARATOR

MMC therapy alone (n=10)

Drug: MMC

Interventions

RanibizumabDRUG

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

Ranibizumab alone
Ranibizumab and MMCDRUG

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

Also known as: Ranibizumab and Mitomycin C
Ranibizumab and MMC
MMCDRUG

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

Also known as: Mitomycin C
MMC alone

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • glaucoma
  • undergoing trabeculectomy
  • years of age or older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rocky Mountain Lions Eye Institute

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

  • Kahook MY. Bleb morphology and vascularity after trabeculectomy with intravitreal ranibizumab: a pilot study. Am J Ophthalmol. 2010 Sep;150(3):399-403.e1. doi: 10.1016/j.ajo.2010.03.025. Epub 2010 Jun 8.

    PMID: 20570237DERIVED

MeSH Terms

Conditions

Glaucoma

Interventions

RanibizumabMitomycin

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsMitomycinsIndolequinonesQuinonesOrganic ChemicalsAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Dr.Malik Kahook
Organization
University of Colorado Denver
malik.kahook@ucdenver.edu
720-848-2020

Study Officials

  • Malik Y. Kahook, MD

    Rocky Mountain Lions Eye institute

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2008

First Posted

April 18, 2008

Study Start

April 1, 2008

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

October 13, 2016

Results First Posted

October 13, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Subject medical information obtained by this study is confidential, and disclosure to third parties other than those noted below is prohibited. Upon the subject's permission, medical information may be given to his/her personal physician or other appropriate medical personnel responsible for his/her welfare. Data generated by this study will be available for inspection upon request by representatives of the U.S. FDA, national and local health authorities, the drug manufacturer and the IRB/EC, if appropriate.

Locations

US(1)