Condition category
Eye Diseases
Date applied
10/08/2010
Date assigned
18/08/2010
Last edited
26/05/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Frank Bochmann

ORCID ID

Contact details

Augenklinik
Luzerner Kantonsspital
CH-6000 Luzern 16
Lucerne
6000
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2009DR2127

Study information

Scientific title

Influence of topical anti-VEGF (Ranibizumab) on the outcome of filtration surgery for glaucoma: A two phased study with a randomised placebo controlled trial

Acronym

Study hypothesis

This is a two phased study in patients who underwent trabelculectomy with mitomycin C combined with phacoemulsification and intra ocular lens (IOL) implantation.
1. Assessing the local tolerability and safety of topical ranibizumab
2. Assessing the efficacy of topical ranibizumab against placebo

Ethics approval

1. The local Ethics committee approved on the 24th of October 2008
2. Swissmedic, the Swiss Food and Drug Administration approved on the 25th of June 2009 (ref: 2009DR2127)

Study design

Phase I: Follow-up study
Phase II: Randomised Controlled Trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Glaucoma, patients with excessive wound healing after trabeculectomy.

Intervention

Topical ranibizumab eyedrops (2mg/ml) four times daily for 1 month or placebo (BSS 4x/d for 1 month

Intervention type

Other

Phase

Phase II/III

Drug names

Primary outcome measures

Differences in the intraocular eye pressure, measured at 4 weeks, 3 and 6 months

Secondary outcome measures

1. Bleb appearance / vascularisation using a standardized photography and the Moorfields bleb grading system
2. Postoperative intraocular pressure
3. Conjunctival wound healing problems
All outcomes will be measured at 4 weeks, 3 and 6 months.

Overall trial start date

01/01/2011

Overall trial end date

31/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with primary open angle glaucoma (POAG), PEX and pigment dispersion Glaucoma
2. At least 18 years of age
3. No previous intraocular surgery undergoing trabeculectomy or phaco-trabeculectomy

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50 patients, 25 in each arm

Participant exclusion criteria

1. Patients with primary angle closure glaucoma (PACG)
2. Glaucoma due to other causes
3. Previous intra- and extraocular surgery
4. Any surgery during the last 3 months
5. Patients with uveitis or inflammatory ocular surface disease
6. Patients with single eyes
7. Patients presenting the first postoperative day with bleb leak, hypotony or situations that potentially need another surgery
8. Pregnant and breast feeding women
9. Women planning to get pregnant

Recruitment start date

01/01/2011

Recruitment end date

31/12/2011

Locations

Countries of recruitment

Switzerland

Trial participating centre

Augenklinik
Lucerne
6000
Switzerland

Sponsor information

Organisation

Horten Center, University of Zurich (Switzerland)

Sponsor details

c/o Prof Lucas Bachmann
Postfach Nord USZ
CH-8091
Zurich
8091
Switzerland

Sponsor type

Not defined

Website

Funders

Funder type

Charity

Funder name

Horten Center, University of Zurich (Switzerland) - core funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Lucerne Eye Clinic (Switzerland) - core funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Novartis (Switzerland) - providing active medications

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21241468

Publication citations

  1. Protocol

    Bochmann F, Kaufmann C, Becht CN, Guber I, Kaiser M, Bachmann LM, Thiel MA, ISRCTN12125882 - Influence of topical anti-VEGF (Ranibizumab) on the outcome of filtration surgery for glaucoma - Study Protocol., BMC Ophthalmol, 2011, 11, 1, doi: 10.1186/1471-2415-11-1.

Additional files

Editorial Notes