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- Jetrea (ocriplasmin) / Thrombogenics
Myopic macular hole detachment associated with intravitreal ocriplasmin () - Sep 26, 2019 - Abstract #EURETINA2019EURETINA_1320;
Ocriplasmin functions in a twofold manner; inducing a posterior vitreous detachment and as a proteolytic enzyme digesting the fibronectin and laminin at the pathological vitreoretinal interface. With access through a FTMH, ocriplasmin could exert an enzymatic effect on the interphotoreceptor matrix that normally helps maintain neuroretinal adhesion to the retinal pigment epithelium.
- | Jetrea (ocriplasmin) / Thrombogenics
Journal, HEOR: Budget impact analysis of ocriplasmin for the treatment of symptomatic vitreomacular adhesion in the USA. (Pubmed Central) - Sep 26, 2019
With access through a FTMH, ocriplasmin could exert an enzymatic effect on the interphotoreceptor matrix that normally helps maintain neuroretinal adhesion to the retinal pigment epithelium. Ocriplasmin was projected to be minimally cost-additive at US$0.0060 per-member per-month over 2 years.
- | Jetrea (ocriplasmin) / Thrombogenics
Journal: Long-Term Persistence of Subfoveal Fluid Following Ocriplasmin-Treatment of an FTMH. (Pubmed Central) - Sep 8, 2019
Ocriplasmin was projected to be minimally cost-additive at US$0.0060 per-member per-month over 2 years. No abstract available
- | Jetrea (ocriplasmin) / Thrombogenics
Journal: Enzymatic vitreolysis for the treatment of tractional diabetic macular edema. (Pubmed Central) - Sep 7, 2019
Adverse events were mild and transitory. Release of vitreomacular adhesion <2500 μm through enzymatic vitreolysis contributed to the control and stabilization of diabetic macular edema with fewer anti-vascular endothelial growth factor injections, reducing the burden and the risks related to these invasive and frequently chronic treatments.
- | Jetrea (ocriplasmin) / Thrombogenics
Journal: Vitreomacular Interface Diseases: Vitreomacular Adhesion, Vitreomacular Traction, Epiretinal Membranes, and Macular Hole (Pubmed Central) - Aug 16, 2019
Pathologic aspects, clinical features, diagnostic implications, and current management strategies are described. Observation, pharmacologic vitreolysis with Ocriplasmin, and surgical treatment are positioned as treatment options for different diseases.
- | Zaltrap (ziv-aflibercept IV) / Sanofi, Regeneron
Review, Journal: Assessing the added benefit of new ophthalmic drugs : Which additional insights can be extracted from the early benefit assessment? (Pubmed Central) - Jul 26, 2019
All remaining agents (aflibercept, bromfenac, nepafenac and tafluprost/timolol) were not recognized as having an added benefit...For two agents (bromfenac and nepafenac) the pharmaceutical company did not even submit a value dossier. The examples from ophthalmology illustrate the methodological and procedural shortcomings of the assessment process and that results of an early benefit assessment should be interpreted with caution.
- | Jetrea (ocriplasmin) / Thrombogenics
Journal: Effect of Ocriplasmin on objectively assessed retinal function after treatment of vitreomacular diseases. (Pubmed Central) - Jul 19, 2019
One single significant difference of all examined parameters mirrors a difference due to chance, even if a negative effect of proteolytic enzymes on laminin and fibronectin of retinal cells cannot be entirely excluded. Nevertheless, this result should be respected in order to ensure a safe use of ocriplasmin for patients with vitreoretinal disorders.
- | Jetrea (ocriplasmin) / Thrombogenics
Review, Journal: Pathogenesis and Management of Macular Hole: Review of Current Advances. (Pubmed Central) - Jun 14, 2019
There are plenty of publications indicating that in the management of small and medium size hole (less than 400 µm), use of long-lasting gas and face-down position is not always required; however, it may be necessary for the treatment of large holes. Ocriplasmin and expansile gas had been reported to be successful for management of small- and medium-sized holes and vitreomacular attachment.
- | Jetrea (ocriplasmin) / Thrombogenics
Journal: Reduced perfusion density of superficial retinal capillary plexus after intravitreal ocriplasmin injection for idiopathic vitreomacular traction. (Pubmed Central) - Jun 3, 2019
After ocriplasmin injection the perfusion density in the SCP is reduced, regardless the anatomical success. Limited by the small sample size and the pilot nature of the study, we found microvascular changes after ocriplasmin injection, which may be due to retinal traction release.
- | Jetrea (ocriplasmin) / Thrombogenics
Journal: Ocriplasmin versus vitrectomy for the treatment of macular holes. (Pubmed Central) - May 9, 2019
Both procedures were associated with improved visual outcomes, but eyes initially treated with vitrectomy had a higher primary MH closure rate. On OCT, patients had more outer structural changes in vitrectomy eyes than in ocriplasmin eyes.
- | Jetrea (ocriplasmin) / Thrombogenics
Journal: Flare changes after intravitreal injection of ocriplasmin in symptomatic vitreomacular traction syndrome. (Pubmed Central) - May 6, 2019
On OCT, patients had more outer structural changes in vitrectomy eyes than in ocriplasmin eyes. Our study shows that intravitreal injection of ocriplasmin can be a safe and effective approach to treat symptomatic VMT syndrome in selected patients.
- || Jetrea (ocriplasmin) / Thrombogenics
Severe photopsia and photophobia after #ocriplasmin #Jetrea. #ophthalmology #ARVO2019 #retina #VMT #vitreous (Twitter) - Apr 28, 2019
- | Jetrea (ocriplasmin) / Thrombogenics
Clinical, Review, Journal: Patient-reported outcomes of ocriplasmin for the treatment of vitreomacular traction: a systematic review and synthesis of the literature. (Pubmed Central) - Apr 18, 2019
Ocriplasmin results in a significant improvement in visual functioning. Future research could include the development of new PROs specific to VMT.
- | Jetrea (ocriplasmin) / Thrombogenics
Clinical, Journal: Initial Clinical Experiences Using Ocriplasmin for the Treatment of Vitreomacular Traction with or without a Macular Hole (Pubmed Central) - Apr 7, 2019
Intravitreal injection of ocriplasmin appears is an experimental therapy in patients with symptomatic vitreomacular traction. Patient selection seems to be critically important for the therapeutic outcome, whereas greater age, specific VMT morphology and missing chromatopsia seem to be negative predictors.
- | Jetrea (ocriplasmin) / Thrombogenics
Journal: Ocriplasmin retinopathy: Possible cause of macular hole closure failure. (Pubmed Central) - Apr 5, 2019
Patient selection seems to be critically important for the therapeutic outcome, whereas greater age, specific VMT morphology and missing chromatopsia seem to be negative predictors. Further studies may be warranted to fully understand the impact of ocriplasmin on long-term visual function.
- | Jetrea (ocriplasmin) / Thrombogenics
Clinical, Journal: Calculating the individual probability of successful ocriplasmin treatment in eyes with VMT syndrome: a multivariable prediction model from the EXPORT study. (Pubmed Central) - Apr 3, 2019
Known predictive factors for VMT resolution after ocriplasmin IVI were confirmed in our study. We were able to combine them into a formula, ultimately allowing the calculation of an individual probability of treatment success with ocriplasmin in patients with VMT syndrome without FTHM.
- | Jetrea (ocriplasmin) / Thrombogenics
Journal, HEOR: Updated Cost-Effectiveness of Intravitreal Ocriplasmin for Vitreomacular Adhesion and Macular Hole. (Pubmed Central) - Mar 27, 2019
[Ophthalmic Surg Lasers Imaging Retina. 2018;49:e240-e248.].
- || Trial primary completion date: CIRCLE: A Study to Evaluate the Efficacy and Safety of Ocriplasmin in Inducing Total PVD in Subjects With NPDR (clinicaltrials.gov) - Feb 1, 2019
P2, N=115, Active, not recruiting, Sponsor: ThromboGenics
2018;49:e240-e248.]. Trial primary completion date: Jul 2019 --> Dec 2019
- | Jetrea (ocriplasmin) / Oxurion
Trial completion, Trial primary completion date: RVC_CRVO: Phase I RVC With Ocriplasmin for CRVO (clinicaltrials.gov) - Jan 8, 2018
P1, N=4, Completed, Sponsor: Universitaire Ziekenhuizen Leuven
Trial primary completion date: Jul 2019 --> Dec 2019 Recruiting --> Completed | Trial primary completion date: Jun 2018 --> Aug 2017
- ||| Enrollment closed: CIRCLE: A Study to Evaluate the Efficacy and Safety of Ocriplasmin in Inducing Total PVD in Subjects With NPDR (clinicaltrials.gov) - Jan 4, 2018
P2, N=115, Active, not recruiting, Sponsor: ThromboGenics
Recruiting --> Completed | Trial primary completion date: Jun 2018 --> Aug 2017 Recruiting --> Active, not recruiting
- || Jetrea (ocriplasmin) / Oxurion
Trial primary completion date: Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion (clinicaltrials.gov) - Jan 13, 2017
P4, N=62, Completed, Sponsor: Alcon Research
Recruiting --> Active, not recruiting Trial primary completion date: May 2016 --> Dec 2015
- Jetrea (ocriplasmin) / Oxurion
Enrollment open, P1 data, Trial initiation date: RVC_CRVO: Phase I RVC With Ocriplasmin for CRVO (clinicaltrials.gov) - Jan 5, 2017
P1, N=6, Recruiting, Sponsor: Universitaire Ziekenhuizen Leuven
Trial primary completion date: May 2016 --> Dec 2015 Not yet recruiting --> Recruiting | Initiation date: Aug 2016 --> Dec 2016
- ||| Enrollment change, Trial primary completion date: CIRCLE: A Study to Evaluate the Efficacy and Safety of Ocriplasmin in Inducing Total PVD in Subjects With NPDR (clinicaltrials.gov) - Dec 28, 2016
P2, N=115, Recruiting, Sponsor: ThromboGenics
Not yet recruiting --> Recruiting | Initiation date: Aug 2016 --> Dec 2016 N=230 --> 115 | Trial primary completion date: Dec 2018 --> Jul 2019
- Jetrea (ocriplasmin) / Oxurion
P1 data, Enrollment change: RVC_CRVO: Phase I RVC With Ocriplasmin for CRVO (clinicaltrials.gov) - Jul 19, 2016
P1, N=6, Not yet recruiting, Sponsor: Universitaire Ziekenhuizen Leuven
N=230 --> 115 | Trial primary completion date: Dec 2018 --> Jul 2019 N=30 --> 6
- ||| Trial completion: Ocriplasmin Research to Better Inform Treatment (ORBIT) (clinicaltrials.gov) - Jun 21, 2016
P=N/A, N=540, Completed, Sponsor: ThromboGenics
N=30 --> 6 Active, not recruiting --> Completed
- |||| Jetrea (ocriplasmin) / Oxurion
Trial completion: Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion (clinicaltrials.gov) - May 26, 2016
P4, N=62, Completed, Sponsor: Alcon Research
Active, not recruiting --> Completed Active, not recruiting --> Completed
- || Enrollment closed, Enrollment change: Ocriplasmin Research to Better Inform Treatment (ORBIT) (clinicaltrials.gov) - May 3, 2016
P=N/A, N=540, Active, not recruiting, Sponsor: ThromboGenics
Active, not recruiting --> Completed Recruiting --> Active, not recruiting | N=1500 --> 540
- Jetrea (ocriplasmin) / Oxurion
New P1 trial, P1 data: RVC_CRVO: Phase I RVC With Ocriplasmin for CRVO (clinicaltrials.gov) - Apr 21, 2016
P1, N=30, Not yet recruiting, Sponsor: Universitaire Ziekenhuizen Leuven
- || Phase classification: Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole (clinicaltrials.gov) - Mar 15, 2016
P3, N=220, Completed, Sponsor: ThromboGenics
Recruiting --> Active, not recruiting | N=1500 --> 540 Phase classification: P2 --> P3
- ||||| New P2 trial: CIRCLE: A Study to Evaluate the Efficacy and Safety of Ocriplasmin in Inducing Total PVD in Subjects With NPDR (clinicaltrials.gov) - Feb 12, 2016
P2, N=230, Recruiting, Sponsor: ThromboGenics
- ||| Jetrea (ocriplasmin) / Oxurion
Enrollment change: Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion (clinicaltrials.gov) - Jan 7, 2016
P4, N=62, Active, not recruiting, Sponsor: Alcon Research
Phase classification: P2 --> P3 N=400 --> 62
- ||| Jetrea (ocriplasmin) / Oxurion
Enrollment closed: Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion (clinicaltrials.gov) - Nov 16, 2015
P4, N=400, Active, not recruiting, Sponsor: Alcon Research
N=400 --> 62 Recruiting --> Active, not recruiting
- || Jetrea (ocriplasmin) / Oxurion
Trial primary completion date: Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion (clinicaltrials.gov) - Oct 23, 2015
P4, N=400, Recruiting, Sponsor: Alcon Research
Recruiting --> Active, not recruiting Trial primary completion date: Sep 2016 --> Jun 2016
- |||| Jetrea (ocriplasmin) / Oxurion
Trial completion, Enrollment change: Assessment of Patients Treated With JETREA® for Vitreomacular Traction (clinicaltrials.gov) - Sep 15, 2015
P4, N=628, Completed, Sponsor: Alcon Research
Trial primary completion date: Sep 2016 --> Jun 2016 Active, not recruiting --> Completed | N=400 --> 628
- Trial completion, Retrospective data, Review, Enrollment change: OZONE: A Retrospective Chart Review of Patients Treated With Ocriplasmin for Symptomatic VMA (clinicaltrials.gov) - Jul 9, 2015
P=N/A, N=134, Completed, Sponsor: ThromboGenics
Active, not recruiting --> Completed | N=400 --> 628 Recruiting --> Completed | N=200 --> 134
- |||| Jetrea (ocriplasmin) / Oxurion
Enrollment open: Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion (clinicaltrials.gov) - Jun 2, 2015
P4, N=400, Recruiting, Sponsor: Alcon Research
Recruiting --> Completed | N=200 --> 134 Not yet recruiting --> Recruiting
- ||| Jetrea (ocriplasmin) / Oxurion
Enrollment closed: Assessment of Patients Treated With JETREA® for Vitreomacular Traction (clinicaltrials.gov) - Feb 12, 2015
P4, N=400, Active, not recruiting, Sponsor: Alcon Research
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
- || Retrospective data, Review, Trial primary completion date: OZONE: A Retrospective Chart Review of Patients Treated With Ocriplasmin for Symptomatic VMA (clinicaltrials.gov) - Jan 15, 2015
P=N/A, N=200, Recruiting, Sponsor: ThromboGenics
Recruiting --> Active, not recruiting Trial primary completion date: Nov 2014 --> Feb 2015
- ||||| Jetrea (ocriplasmin) / Oxurion
New P4 trial: Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion (clinicaltrials.gov) - Dec 24, 2014
P4, N=400, Not yet recruiting, Sponsor: Alcon Research
- || Jetrea (ocriplasmin) / Oxurion
Trial primary completion date: Assessment of Patients Treated With JETREA® for Vitreomacular Traction (clinicaltrials.gov) - Nov 13, 2014
P4, N=400, Recruiting, Sponsor: Alcon Research
Trial primary completion date: Nov 2014 --> Feb 2015 Trial primary completion date: Jun 2015 --> Oct 2015
- |||| Trial completion: Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole (clinicaltrials.gov) - Nov 11, 2014
P2, N=220, Completed, Sponsor: ThromboGenics
Trial primary completion date: Jun 2015 --> Oct 2015 Active, not recruiting --> Completed
- | Trial completion: Intravenous Administration of Microplasmin for Treatment of Acute Ischemic Stroke (clinicaltrials.gov) - Nov 5, 2014
P2, N=40, Completed, Sponsor: ThromboGenics
Active, not recruiting --> Completed Active, not recruiting --> Completed
- ||||||| Jetrea (ocriplasmin) / Oxurion
Trial completion, P3 data, Enrollment change: A Phase III Study of A01016 in Subjects With Symptomatic Vitreomacular Adhesion (clinicaltrials.gov) - Sep 15, 2014
P3, N=252, Completed, Sponsor: Alcon Research
Active, not recruiting --> Completed Active, not recruiting --> Completed | N=168 --> 252
- ||| Enrollment open, Retrospective data, Review: OZONE: A Retrospective Chart Review of Patients Treated With Ocriplasmin for Symptomatic VMA (clinicaltrials.gov) - Aug 21, 2014
P=N/A, N=200, Recruiting, Sponsor: ThromboGenics
Active, not recruiting --> Completed | N=168 --> 252 Not yet recruiting --> Recruiting
- ||| Retrospective data, Review: OZONE: A Retrospective Chart Review of Patients Treated With Ocriplasmin for Symptomatic VMA (clinicaltrials.gov) - Jul 18, 2014
P=N/A, N=200, Not yet recruiting, Sponsor: ThromboGenics
- || Jetrea (ocriplasmin) / Oxurion
Trial primary completion date: Assessment of Patients Treated With JETREA® for Vitreomacular Traction (clinicaltrials.gov) - May 22, 2014
P4, N=400, Recruiting, Sponsor: Alcon Research
Not yet recruiting --> Recruiting Trial primary completion date: Oct 2015 --> Jun 2015
- || Jetrea (ocriplasmin) / Oxurion
Trial completion date: Assessment of Patients Treated With JETREA® for Vitreomacular Traction (clinicaltrials.gov) - May 22, 2014
P4, N=400, Recruiting, Sponsor: Alcon Research
Trial primary completion date: Oct 2015 --> Jun 2015 Trial completion date: Oct 2015 --> Jun 2015
- || Trial initiation date: Ocriplasmin Research to Better Inform Treatment (ORBIT) (clinicaltrials.gov) - May 1, 2014
P=N/A, N=1500, Recruiting, Sponsor: ThromboGenics
Trial completion date: Oct 2015 --> Jun 2015 Initiation date: Apr 2014 --> May 2014
- |||| Jetrea (ocriplasmin) / Oxurion
Enrollment open: Assessment of Patients Treated With JETREA® for Vitreomacular Traction (clinicaltrials.gov) - Apr 27, 2014
P4, N=400, Recruiting, Sponsor: Alcon Research
Initiation date: Apr 2014 --> May 2014 Not yet recruiting --> Recruiting
- ||| Enrollment open: Ocriplasmin Research to Better Inform Treatment (ORBIT) (clinicaltrials.gov) - Apr 22, 2014
P=N/A, N=1500, Recruiting, Sponsor: ThromboGenics
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting