Trial of Microplasmin Intravitreal Injection for Non-Surgical Treatment of Focal Vitreomacular Adhesion. The MIVI-TRUST (TG-MV-007) Trial.

• Ocriplasmin 125µg (Drug), also known as Microplasmin: 125µg of ocriplasmin intravitreal injection
• Placebo (Drug): Intravitreal injection placebo.

Primary outcomes

• Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28 [Day 28]: Proportion of subjects with nonsurgical resolution of focal vitreomacular adhesion at Day 28, as determined by masked Central Reading Centre (CRC) Optical Coherence Tomography(OCT)evaluation.

Secondary outcomes

• Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28 [Day 28]: Proportion of subjects with total PVD at Day 28, as determined by masked investigator assessment of B-scan ultrasound.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Presence of focal vitreomacular adhesion (i.e., central vitreal adhesion within 6 mm Optical Coherence Tomography (OCT) field surrounded by elevation of the posterior vitreous cortex) that in the opinion of the Investigator is related to decreased visual function (such as metamorphopsia, decreased visual acuity, or other visual complaint)

Exclusion Criteria:

* Any evidence of proliferative retinopathy (including Proliferative Diabetic Retinopathy (PDR)) or other ischemic retinopathies involving vitreoretinal vascular proliferation) or exudative Age-Related Macular Degeneration (AMD) or retinal vein occlusion in the study eye
* Subjects with any vitreous hemorrhage or any other vitreous opacification which precludes either of the following: visualization of the posterior pole by visual inspection OR adequate assessment of the macula by either OCT and/or fluorescein angiogram in the study eye
* Subjects with macular hole diameter > 400 µm in the study eye
* Aphakia in the study eye
* High myopia (more than 8D) in study eye (unless prior cataract extraction or refractive surgery that makes refraction assessment unreliable for myopia severity approximation, in which case axial length >28 mm is an exclusion).

Participant flow

Outcome results

• Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28 (Primary), Number, percentage of participants: Ocriplasmin 125µg 25.3; Placebo 6.2 (p <0.001)
• Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28 (Secondary), Number, percentage of participants: Ocriplasmin 125µg 10.6; Placebo 0

Adverse events

Time frame: Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection

Serious adverse events by term

Other adverse events by term

• Results publication: Varma R, Haller JA, Kaiser PK. 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. JAMA Ophthalmol. 2015 Sep;133(9):997-1004. doi: 10.1001/jamaophthalmol.2015.1746. PMID 26068086
• Results publication: Folgar FA, Toth CA, DeCroos FC, Girach A, Pakola S, Jaffe GJ. Assessment of retinal morphology with spectral and time domain OCT in the phase III trials of enzymatic vitreolysis. Invest Ophthalmol Vis Sci. 2012 Oct 25;53(11):7395-401. doi: 10.1167/iovs.12-10379. PMID 23033391
• Results publication: Stalmans P, Benz MS, Gandorfer A, Kampik A, Girach A, Pakola S, Haller JA; MIVI-TRUST Study Group. Enzymatic vitreolysis with ocriplasmin for vitreomacular traction and macular holes. N Engl J Med. 2012 Aug 16;367(7):606-15. doi: 10.1056/NEJMoa1110823. PMID 22894573
• Results publication: DeCroos FC, Toth CA, Folgar FA, Pakola S, Stinnett SS, Heydary CS, Burns R, Jaffe GJ. Characterization of vitreoretinal interface disorders using OCT in the interventional phase 3 trials of ocriplasmin. Invest Ophthalmol Vis Sci. 2012 Sep 21;53(10):6504-11. doi: 10.1167/iovs.12-10370. PMID 22879421