A Phase 1/2 interventional study of V404 in Uveitis, Posterior and Uveitis, Intermediate, sponsored by Forsight Vision4. Terminated at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-09.
Sponsored by Forsight Vision4 · Phase 1/2, Interventional, and Treatment
This study is intended to evaluate the safety of V404 PDS in patients with chronic non-infectious uveitis. Secondarily, the study will evaluate whether V404 PDS can provide clinically measurable benefit over an extended period of time in patients with chronic non-infectious uveitis.
61 studies on the registry are indexed under Uveitis, Posterior; 4 are open to participants now.
This study's enrollment of 7 is below the median of 37 across 45 interventional studies indexed under Uveitis, Posterior.
Browse Uveitis, Posterior studies →Forsight Vision4 is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sustained intravitreal delivery of methotrexate (0.6 mg)
Drug: V404
Sustained intravitreal delivery of methotrexate (2.3 mg)
Drug: V404
Sustained Release
Also known as: Methotrexate
Frequency of adverse events
Time frame: 6 months
Change in vitreous haze score
Time frame: Baseline, 6 Months
Change in macular thickness by ocular coherence tomography
Time frame: Baseline, 6 Months
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Apr 2014, a primary completion of Oct 2014 and a completion of Mar 2015. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Methotrexate