NCT00626782

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2008

Typical duration for phase_2

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

January 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 29, 2008

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
4 years until next milestone

Results Posted

Study results publicly available

March 13, 2015

Completed
Last Updated

March 22, 2018

Status Verified

February 1, 2018

Enrollment Period

3.2 years

First QC Date

February 20, 2008

Results QC Date

February 11, 2015

Last Update Submit

February 23, 2018

Conditions

Glaucoma

Keywords

glaucomaglucoma filtering surgeryranibizumabmitomycin Cpatients requiring first time glaucoma filtering surgery

Outcome Measures

Primary Outcomes (1)

  • Adverse Events

    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.

    12 months

Secondary Outcomes (1)

  • Post-Operative Requirement for Glaucoma Medication

    1 day, 2 wks, 1, 3, 6 and 12 months

Study Arms (2)

A: Ranibizumab 0.5mg (0.05mL) injection

EXPERIMENTAL

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.

Drug: Ranibizumab

B: Mitomycin C 0.4 mg/ml sponge

ACTIVE COMPARATOR

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)

Interventions

RanibizumabDRUG

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

Also known as: Lucentis
A: Ranibizumab 0.5mg (0.05mL) injection
Mitomycin (MMC)DRUG

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

Also known as: MMC C 0.4 mg/ml
B: Mitomycin C 0.4 mg/ml sponge

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • yrs or older
  • patients requiring first time glaucoma filtering surgery
  • phakic or pseudophakic
  • must provide written informed consent and comply with study assignments

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wills Eye Hospital, Glaucoma Service

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

  • Pro MJ, Freidl KB, Neylan CJ, Sawchyn AK, Wizov SS, Moster MR. Ranibizumab versus mitomycin C in primary trabeculectomy--a pilot study. Curr Eye Res. 2015 May;40(5):510-5. doi: 10.3109/02713683.2014.935441. Epub 2014 Jul 14.

    PMID: 25019269RESULT

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

Limitations and Caveats

Small sample size. Different surgical techniques among multiple surgeons.

Results Point of Contact

Title
Prinicipal Investigator
Organization
Wills Eye Hospital
mpro2020@yahoo.com
484-434-2700

Study Officials

  • Michael J Pro, MD

    Wills Eye Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients requiring trabeculectomy were randomly assigned to either MMC or Ranibizumab during surgery.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 20, 2008

First Posted

February 29, 2008

Study Start

January 1, 2008

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

March 22, 2018

Results First Posted

March 13, 2015

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)