NCT00798317

A Randomized, Placebo Controlled, Double-masked, Multicenter Trial of Microplasmin Intravitreal Injection for Non-surgical Treatment of Focal Vitreomacular Adhesion.

Completed Phase 3 Results posted Last updated 2 December 2014

What this trial tests

Phase 3 trial testing Ocriplasmin 125µg in Vitreomacular Adhesion in 326 participants. Completed in 1 July 2010.

Timeline

1 December 2008

Primary endpoint
1 June 2010

1 July 2010

Quick facts

Lead sponsor	ThromboGenics
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	326
Start date	1 December 2008
Primary completion	1 June 2010
Estimated completion	1 July 2010
Sites	48 locations across United States, Belgium, Czechia, Germany, Poland, Spain, United Kingdom

Drugs / interventions tested

• Ocriplasmin 125µg — full drug profile →
• Placebo

Conditions studied

• Vitreomacular Adhesion — all drugs for Vitreomacular Adhesion →

Sponsor

ThromboGenics — full company profile →

Who can join

18 and older, any sex, with Vitreomacular Adhesion. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28
  Time frame: 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.

Sponsor's own description

This trial will evaluate the safety and efficacy of microplasmin, administered as an intravitreal injection, in subjects with focal vitreomacular adhesion. In previously performed clinical trials, some patients treated with intravitreal microplasmin have had resolution of their underlying condition, including macular hole closure, without need for vitrectomy. This clinical trial is justified because the sponsor believes the potential benefits outweigh the potential risks.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Enzymatic vitreolysis with ocriplasmin for vitreomacular traction and macular holes.
   Stalmans P, Benz MS, Gandorfer A, Kampik A, et al · · 2012 · cited 373× · PMID 22894573 · DOI 10.1056/nejmoa1110823
2. 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.
   Varma R, Haller JA, Kaiser PK. · · 2015 · cited 31× · PMID 26068086 · DOI 10.1001/jamaophthalmol.2015.1746
3. Characterization of vitreoretinal interface disorders using OCT in the interventional phase 3 trials of ocriplasmin.
   DeCroos FC, Toth CA, Folgar FA, Pakola S, et al · · 2012 · cited 16× · PMID 22879421 · DOI 10.1167/iovs.12-10370
4. Assessment of retinal morphology with spectral and time domain OCT in the phase III trials of enzymatic vitreolysis.
   Folgar FA, Toth CA, DeCroos FC, Girach A, et al · · 2012 · cited 15× · PMID 23033391 · DOI 10.1167/iovs.12-10379
5. EVALUATION OF FULL-FIELD ELECTRORETINOGRAM REDUCTIONS AFTER OCRIPLASMIN TREATMENT: Results of the OASIS Trial ERG Substudy.
   Birch DG, Benz MS, Miller DM, Antoszyk AN, et al · · 2018 · cited 12× · PMID 28198785 · DOI 10.1097/iae.0000000000001536
6. Visual function response to ocriplasmin for the treatment of vitreomacular traction and macular hole.
   Jackson TL, Verstraeten T, Duchateau L, Lescrauwaet B. · · 2017 · cited 11× · PMID 28133919 · DOI 10.1111/aos.13369
7. PATIENT-REPORTED VISUAL FUNCTION FROM THE OCRIPLASMIN FOR TREATMENT FOR SYMPTOMATIC VITREOMACULAR ADHESION, INCLUDING MACULAR HOLE (OASIS) STUDY.
   Mein C, Dugel PU, Feiner L, Drenser K, et al · · 2020 · cited 6× · PMID 31259807 · DOI 10.1097/iae.0000000000002599
8. Ocriplasmin use in a selected case with preserved visual acuity.
   Rossi S, Orrico A, Melillo P, Testa F, et al · · 2015 · cited 5× · PMID 26511080 · DOI 10.1186/s12886-015-0141-9