Send to

Choose Destination
JAMA Ophthalmol. 2015 Sep;133(9):997-1004. doi: 10.1001/jamaophthalmol.2015.1746.

Improvement in Patient-Reported Visual Function After Ocriplasmin for Vitreomacular Adhesion: Results of the Microplasmin for Intravitreous Injection-Traction Release Without Surgical Treatment (MIVI-TRUST) Trials.

Author information

Department of Ophthalmology, Keck School of Medicine, University of Southern California, Los Angeles2University of Southern California Eye Institute, Los Angeles.
Wills Eye Hospital, Philadelphia, Pennsylvania.
Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.



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.


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.


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.


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.


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.


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.


Ocriplasmin produces clinically meaningful improvement in patient-reported visual function in symptomatic VMA/VMT.

TRIAL REGISTRATION: Identifiers: NCT00781859 and NCT00798317.

[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Silverchair Information Systems
Loading ...
Support Center