ISRCTN12125882 - Influence of topical anti-VEGF (Ranibizumab) on the outcome of filtration surgery for glaucoma - Study Protocol.
BACKGROUND
Excessive wound healing, with scarring of the episcleral tissue or encapsulation of the filtering bleb is the main reason for failure in trabeculectomy. Ranibizumab, an inhibitor of the Vascular Endothelial Growth Factor (VEGF), is seen as a promising candidate to prevent or treat extensive wound healing. We describe the design of a two phased study, i) assessing the local tolerability and safety of topical ranibizumab and ii) assessing the efficacy of topical ranibizumab against placebo in patients who underwent trabeculectomy with mitomycin C combined with phacoemulsification and intra ocular lens (IOL) implantation.


METHODS
In the first phase five patients that had trabeculectomy with mitomycin C combined with phacoemulsification and IOL implantation will be treated with topical ranibizumab (Lucentis®) eye drops (2 mg/ml) four times daily for one month. The treatment will be started at the first postoperative day. Patients will be assessed for local and systemic side effects using a standardised schedule. In the second phase, after successful completion of phase 1, consenting eligible patients who underwent trabeculectomy with mitomycin C combined with phacoemulsification and IOL implantation will be randomised to either receive topical ranibizumab eye drops (2 mg/ml) four times daily for 1 month or placebo (BSS 4x/d for 1 month). Patients will be reviewed weekly for 4 weeks until conjunctival sutures are removed. Further follow up examinations are planned after 3 and six months. Assessment of differences in the intraocular eye pressure will be considered primary, and bleb appearance/vascularisation using a standardized photography and the Moorfields bleb grading system, postoperative intraocular pressure and conjunctival wound healing problems will be considered secondary outcome parameters.


CONCLUSIONS
Anti-VEGF-antibodies might be more effective in preventing scaring and might have fewer toxic side effects than the currently used anti-metabolites and may replace them in the long term.
Department of Ophthalmology, Lucerne Cantonal Hospital, Lucerne, Switzerland. frank.bochmann@ksl.ch
Frank
F
Bochmann
Claude
C
Kaufmann
Christoph N
CN
Becht
Ivo
I
Guber
Michael
M
Kaiser
Lucas M
LM
Bachmann
Michael A
MA
Thiel
D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D003228:Conjunctiva / Q000601:surgery; D004334:Drug Administration Schedule; D005500:Follow-Up Studies; D005901:Glaucoma / Q000503:physiopathology / Q000601:surgery*; D006801:Humans; D007429:Intraocular Pressure; D019654:Lens Implantation, Intraocular; D016685:Mitomycin / Q000627:therapeutic use; D009883:Ophthalmic Solutions; D018918:Phacoemulsification; D011184:Postoperative Period; D000069579:Ranibizumab; D012107:Research Design; D013537:Sutures; D014130:Trabeculectomy; D016896:Treatment Outcome; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors*; D014945:Wound Healing
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D009883:Ophthalmic Solutions; D042461:Vascular Endothelial Growth Factor A; D016685:Mitomycin; D000069579:Ranibizumab
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