ISRCTN12125882 - Influence of topical anti-VEGF (Ranibizumab) on the outcome of filtration surgery for glaucoma - Study Protocol

Abstract

BackgroundExcessive 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/DesignIn 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.DiscussionAnti-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.Trial RegistrationISRCTN: ISRCTN12125882

Efficacy of intravitreal ranibizumab combined with Ahmed glaucoma valve implantation for the treatment of neovascular glaucoma

“…Currently available studies on glaucoma treatment have reported the use of anti-VEGF factors under the conjunctiva [ 13 ] and in the anterior chamber [ 7 ] and vitreous cavity [ 14 – 16 ], and even reported that topical eye drops containing ranibizumab (2 mg/mL) after filtering surgery can reduce the formation of bleb scarring [ 17 ]. However, there are large discrepancies in the conclusions reached by a number of small-scale clinical studies on NVG.…”

Effects of Trehalose on VEGF-Stimulated Angiogenesis and Myofibroblast Proliferation: Implications for Glaucoma Filtration Surgery

“…12 A clinical trial designed to examine the efficacy of topically applied ranibizumab eyedrops on fibrous scar formation after GFS is under way. 16 In a previous study, 17 we demonstrated that trehalose inhibited the proliferation of fibroblasts by inducing apoptosis. In rabbit GFS models, we also observed that trehalose inhibited conjunctival neovascularization in bleb areas after GFS.…”

Validation of the Total Visual Acuity Extraction Algorithm (TOVA) for Automated Extraction of Visual Acuity Data From Free Text, Unstructured Clinical Records

“…Natural language processing was used as part of a multimodal approach for extracting cataract cases from broader datasets. In a retrospective review of the Personalized Medicine Research Project (PMRP) cohort, Waudby et al 14 identified 16,336 cataract patients by combining structured database querying of CPT and ICD-9 codes, natural language processing for data mining of text-based notes, and intelligent character recognition (ICR) of handwritten notes. The results of this combined search were validated by manual extraction of each note.…”