VISUAL FUNCTION RESPONSE TO OCRIPLASMIN FOR THE TREATMENT OF VITREOMACULAR TRACTION AND MACULAR HOLE
Author(s)
Jackson T1, Verstraeten T2, Duchateau L3, Lescrauwaet B4
1King’s College Hospital, London, UK, 2P95, Leuven, Belgium, 3Ghent University, Ghent, Belgium, 4Xintera Ltd., London, UK
OBJECTIVES: Vitreomacular adhesion (VMA) can lead to pathologic traction and macular hole formation. The effect of an intravitreal ocriplasmin-injection on VMA resolution was demonstrated in two multicentre, randomized, double-masked, phase 3 clinical trials (MIVI-TRUST). The objective of our analysis was to assess the effect of ocriplasmin on patient relevant visual function outcomes, measured using visual acuity (VA) and vision-related quality of life. METHODS: Post-hoc analysis of prespecified secondary endpoints in MIVI-TRUST. A total of 652 participants with symptomatic VMA were enrolled, of whom 464 received a single intravitreal injection of 125µg ocriplasmin and 188 received a single intravitreal placebo-injection. Visual function response (VFR) was defined as either: a VA improvement of ≥ 2 lines; or an improvement exceeding the minimal clinically important difference (MCID) in the composite score of the National Eye Institute Visual Function Questionnaire (VFQ-25) or in the VFQ-25 driving subscale score. The MCID was estimated using the standard error of measurement approach. The main outcome measure was the VFR at 6 months. RESULTS: The MCID was estimated at 3.6 points for the VFQ-25 composite score and 19.1 for the VFQ-25 driving subscale score. A VFR occurred in 55.1 % of the ocriplasmin-injection group versus 34.2% of the placebo-injection group (P<0.0001). This comprised 23.7% versus 11.2% (P=0.0003) with a ≥ 2 line VA improvement, 35.9% versus 22.7% (P=0.0016) for the VFQ-25 composite score increase > MCID, and 10.2 % versus 6.2% (P=0.1697) for the driving subscale score increase > MCID. CONCLUSIONS: Ocriplasmin produces significant and clinically meaningful visual function benefit to the patient in addition to higher VMA resolution rates. This analysis redefines visual function response and allows patient and physician to consider both anatomical and functional benefits when discussing treatment options.
Conference/Value in Health Info
2014-05, ISPOR 2014, Palais des Congres de Montreal
Value in Health, Vol. 17, No. 3 (May 2014)
Code
PSS34
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Sensory System Disorders