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
Scientific
Augenklinik
Luzerner Kantonsspital
CH-6000 Luzern 16
Lucerne
6000
Switzerland
Study information
| Study design | Phase I: Follow-up study Phase II: Randomised Controlled Trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure | 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 study start date | 01/01/2011 |
| Completion date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50 patients, 25 in each arm |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2011 |
| Date of final enrolment | 31/12/2011 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Augenklinik
Lucerne
6000
Switzerland
6000
Switzerland
Sponsor information
Horten Center, University of Zurich (Switzerland)
Not defined
Not defined
c/o Prof Lucas Bachmann
Postfach Nord USZ
CH-8091
Zurich
8091
Switzerland
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
