Influence of topical anti-VEGF (Ranibizumab) on the outcome of filtration surgery for glaucoma

ISRCTN ISRCTN12125882
DOI https://doi.org/10.1186/ISRCTN12125882
Secondary identifying numbers 2009DR2127
Submission date
10/08/2010
Registration date
18/08/2010
Last edited
26/05/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Frank Bochmann
Scientific

Augenklinik
Luzerner Kantonsspital
CH-6000 Luzern 16
Lucerne
6000
Switzerland

Study information

Study designPhase I: Follow-up study Phase II: Randomised Controlled Trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details below to request a patient information sheet
Scientific titleInfluence of topical anti-VEGF (Ranibizumab) on the outcome of filtration surgery for glaucoma: A two phased study with a randomised placebo controlled trial
Study objectivesThis 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(s)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)
Health condition(s) or problem(s) studiedGlaucoma, patients with excessive wound healing after trabeculectomy.
InterventionTopical ranibizumab eyedrops (2mg/ml) four times daily for 1 month or placebo (BSS 4x/d for 1 month
Intervention typeOther
Primary outcome measureDifferences in the intraocular eye pressure, measured at 4 weeks, 3 and 6 months
Secondary outcome measures1. 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 study start date01/01/2011
Completion date31/12/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants50 patients, 25 in each arm
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/01/2011
Date of final enrolment31/12/2011

Locations

Countries of recruitment

  • Switzerland

Study participating centre

Augenklinik
Lucerne
6000
Switzerland

Sponsor information

Horten Center, University of Zurich (Switzerland)
Not defined

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

ROR logo "ROR" https://ror.org/01462r250

Funders

Funder type

Charity

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

No information available

Lucerne Eye Clinic (Switzerland) - core funding

No information available

Novartis (Switzerland) - providing active medications

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 17/01/2011 Yes No