Association between anatomical resolution and functional outcomes in the mivi-trust studies using ocriplasmin to treat symptomatic vitreomacular adhesion/vitreomacular traction, including when associated with macular hole.
OBJECTIVE
To evaluate visual function in patients with symptomatic vitreomacular adhesion (VMA)/vitreomacular traction including when associated with macular hole after ocriplasmin treatment, and the association between resolution of the underlying condition and improvement in visual function.


METHODS
Six hundred and fifty-two patients from 2 Phase 3 trials received a single intravitreal injection of ocriplasmin 125 μg (n = 464) or placebo (n = 188). Mean and categorical changes from baseline in best-corrected visual acuity and 25-item Visual Function Questionnaire scores were used to evaluate visual function. Subgroups with VMA resolution and full-thickness macular hole closure were compared.


RESULTS
Overall, 42% of patients who achieved VMA resolution at Day 28 had a ≥2-line improvement in best-corrected visual acuity at Month 6, and 20% had a ≥3-line improvement. Likewise, 69% of patients with nonsurgical full-thickness macular hole closure at Day 28 had a ≥2-line improvement at Month 6, and 48% had a ≥3-line best-corrected visual acuity improvement. Mean improvements in 25-item Visual Function Questionnaire scores were associated with achieving VMA resolution and nonsurgical full-thickness macular hole closure.


CONCLUSIONS
In patients with symptomatic VMA/vitreomacular traction, VMA resolution and nonsurgical full-thickness macular hole closure were each associated with improvements in visual function. Resolving the underlying anatomical condition in symptomatic VMA/vitreomacular traction will increase the probability of achieving a clinically meaningful improvement in visual function.
*Department of Ophthalmology, Klinikum der LMU, Munich, Germany; †MVZ, Memmingen, Germany; ‡Retina Consultants of Houston, Houston, Texas; §Wills Eye Hospital, Philadelphia, Pennsylvania; ¶Department of Ophthalmology, UZ Leuven, Leuven, Belgium; **Amakem NV, Diepenbeek, Belgium (formerly of ThromboGenics NV); ††NightstaRx Ltd, London, United Kingdom (formerly of ThromboGenics NV); ‡‡Department of Ophthalmology, Klinikum der LMU, Munich, Germany; and §§Duke Reading Center, Duke University School of Medicine, Durham, North Carolina.
Arnd
A
Gandorfer
Matthew S
MS
Benz
Julia A
JA
Haller
Peter
P
Stalmans
Stephen J
SJ
Pakola
Aniz
A
Girach
Anselm
A
Kampik
Cynthia A
CA
Toth
Glenn J
GJ
Jaffe
D004311:Double-Blind Method; D005128:Eye Diseases / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D005341:Fibrinolysin / Q000009:adverse effects / Q000627:therapeutic use*; D005343:Fibrinolytic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D058449:Intravitreal Injections; D010446:Peptide Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D012164:Retinal Diseases / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D012167:Retinal Perforations / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D018434:Sickness Impact Profile; D011795:Surveys and Questionnaires; D000267:Tissue Adhesions / Q000188:drug therapy; D014792:Visual Acuity / Q000502:physiology*; D014822:Vitreous Body / Q000187:drug effects* / Q000473:pathology
D005343:Fibrinolytic Agents; D010446:Peptide Fragments; C054561:microplasmin; D005341:Fibrinolysin