Rohit Varma1, Julia A Haller2, Peter K Kaiser3. 1. Department of Ophthalmology, Keck School of Medicine, University of Southern California, Los Angeles2University of Southern California Eye Institute, Los Angeles. 2. Wills Eye Hospital, Philadelphia, Pennsylvania. 3. Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.
Abstract
IMPORTANCE: The impact of vitreomacular adhesion (VMA) resolution on patient-reported visual function in symptomatic VMA/vitreomacular traction (VMT) has not yet been documented, to our knowledge. OBJECTIVE: To determine the impact of intravitreal ocriplasmin on patient-reported visual function using the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) during a 6-month follow-up in patients with symptomatic VMA. DESIGN, SETTING, AND PARTICIPANTS: Two multicenter, randomized, masked, phase 3 clinical trials (studies TG-MV-006 [between December 2008 and April 2010] and TG-MV-007 [between December 2008 and July 2010]) at clinic-based centers in the United States and Europe. A total of 652 patients with symptomatic VMA/VMT, including when associated with a macular hole 400 μm or smaller, were studied. Analysis was by intent-to-treat population and performed in May 2013. INTERVENTIONS:Patients with symptomatic VMA/VMT were randomly assigned (2:1 or 3:1 in study TG-MV-006 and study TG-MV-007, respectively) to receive a single intravitreal injection of ocriplasmin, 125 μg, or placebo-injected vehicle (placebo). The NEI VFQ-25 was administered at baseline and 6 months following ocriplasmin injection. MAIN OUTCOMES AND MEASURES: Mean changes between baseline and 6-month follow-up NEI VFQ-25 composite and subscale scores and the proportion of patients with a clinically meaningful change (≥5 points) in scores. RESULTS: Across the 2 studies, 464 patients receivedocriplasmin and 188 received placebo. At 6 months, the ocriplasmin group reported greater mean improvements from baseline in the NEI VFQ-25 composite score than the placebo group (mean change, 3.4 vs 0.7, respectively; P = .005). Improvements were also noted in subscale scores, with the following respective mean changes for the ocriplasmin vs placebo groups: vision-related dependency, 1.7 vs -2.1 (P = .009); driving difficulty, 2.7 vs -1.5 (P = .03); distance vision activities, 4.1 vs 0.8 (P = .03); and general vision, 6.1 vs 2.1 (P = .003). A higher proportion of the ocriplasmin group had a clinically meaningful (≥5-point) improvement in NEI VFQ-25 composite score from baseline than the placebo group (36.0% vs 27.2%, respectively; P = .03). Fewer ocriplasmin-treated patients had a clinically meaningful worsening in their visual function than the placebo group (15.0% vs 24.3%, respectively; P = .005). Changes in NEI VFQ-25 composite score and various subscale scores were observed in ocriplasmin-treated patients who achieved VMA resolution at day 28. CONCLUSIONS AND RELEVANCE: Ocriplasmin produces clinically meaningful improvement in patient-reported visual function in symptomatic VMA/VMT. TRIAL REGISTRATION: clinicaltrials.gov Identifiers: NCT00781859 and NCT00798317.
RCT Entities:
IMPORTANCE: The impact of vitreomacular adhesion (VMA) resolution on patient-reported visual function in symptomatic VMA/vitreomacular traction (VMT) has not yet been documented, to our knowledge. OBJECTIVE: To determine the impact of intravitreal ocriplasmin on patient-reported visual function using the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) during a 6-month follow-up in patients with symptomatic VMA. DESIGN, SETTING, AND PARTICIPANTS: Two multicenter, randomized, masked, phase 3 clinical trials (studies TG-MV-006 [between December 2008 and April 2010] and TG-MV-007 [between December 2008 and July 2010]) at clinic-based centers in the United States and Europe. A total of 652 patients with symptomatic VMA/VMT, including when associated with a macular hole 400 μm or smaller, were studied. Analysis was by intent-to-treat population and performed in May 2013. INTERVENTIONS:Patients with symptomatic VMA/VMT were randomly assigned (2:1 or 3:1 in study TG-MV-006 and study TG-MV-007, respectively) to receive a single intravitreal injection of ocriplasmin, 125 μg, or placebo-injected vehicle (placebo). The NEI VFQ-25 was administered at baseline and 6 months following ocriplasmin injection. MAIN OUTCOMES AND MEASURES: Mean changes between baseline and 6-month follow-up NEI VFQ-25 composite and subscale scores and the proportion of patients with a clinically meaningful change (≥5 points) in scores. RESULTS: Across the 2 studies, 464 patients received ocriplasmin and 188 received placebo. At 6 months, the ocriplasmin group reported greater mean improvements from baseline in the NEI VFQ-25 composite score than the placebo group (mean change, 3.4 vs 0.7, respectively; P = .005). Improvements were also noted in subscale scores, with the following respective mean changes for the ocriplasmin vs placebo groups: vision-related dependency, 1.7 vs -2.1 (P = .009); driving difficulty, 2.7 vs -1.5 (P = .03); distance vision activities, 4.1 vs 0.8 (P = .03); and general vision, 6.1 vs 2.1 (P = .003). A higher proportion of the ocriplasmin group had a clinically meaningful (≥5-point) improvement in NEI VFQ-25 composite score from baseline than the placebo group (36.0% vs 27.2%, respectively; P = .03). Fewer ocriplasmin-treated patients had a clinically meaningful worsening in their visual function than the placebo group (15.0% vs 24.3%, respectively; P = .005). Changes in NEI VFQ-25 composite score and various subscale scores were observed in ocriplasmin-treated patients who achieved VMA resolution at day 28. CONCLUSIONS AND RELEVANCE: Ocriplasmin produces clinically meaningful improvement in patient-reported visual function in symptomatic VMA/VMT. TRIAL REGISTRATION: clinicaltrials.gov Identifiers: NCT00781859 and NCT00798317.
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