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
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
-
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.