I have been fighting iritis for over three solid years. I was just asked today, by my eye specialist, if I would like to particiate in the study listed above. This study will use electric current to deliver the drug to the eye, referred to as "iontophoresis". I am wondering what your thoughts on this treatment are and if you believe it is safe to be a part of this study.
Thanks for the help
Christine
Study: Dexamethasone Phosphate vs. Prednisolone Acetate
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Mike Bartolatz
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Re: Study: Dexamethasone Phosphate vs. Prednisolone Acetate
I am not a doctor and I am ignorant regarding this treatment.
you could ask Dr Foster abou this at his site http://www.uveitis.org
do you have chronic or recurrent uveitis that hasn't resonded to DMARD drugs or other classes of drugs to retrain your immune system to stop attacking your eyes? If it were me, I'd go with things proven to treat uveitis and underlying disease before going to this type of thing. if this is a last resort, ask what the potential complications might be as everything has risk that has to be taken into consideration.
wishing you the very best,
Mike
you could ask Dr Foster abou this at his site http://www.uveitis.org
do you have chronic or recurrent uveitis that hasn't resonded to DMARD drugs or other classes of drugs to retrain your immune system to stop attacking your eyes? If it were me, I'd go with things proven to treat uveitis and underlying disease before going to this type of thing. if this is a last resort, ask what the potential complications might be as everything has risk that has to be taken into consideration.
wishing you the very best,
Mike
Mike Bartolatz
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Mike Bartolatz
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Re: Study: Dexamethasone Phosphate vs. Prednisolone Acetate
Evaluation of Dexamethasone Phosphate Delivered by Ocular Iontophoresis for Treating Noninfectious Anterior Uveitis.
Cohen AE, Assang C, Patane MA, From S, Korenfeld M; Avion Study Investigators.
Source
Eyegate Pharmaceuticals, Inc., Waltham, Massachusetts.
Abstract
PURPOSE:
Determine safe, effective, iontophoretic dose(s) of EGP-437 (dexamethasone phosphate formulated for iontophoresis) in patients with noninfectious anterior uveitis; evaluate systemic drug exposures.
DESIGN:
Prospective, phase I/II, multicenter, double-masked, parallel group, randomized clinical trial.
PARTICIPANTS:
Forty outpatients with anterior uveitis.
METHODS:
Forty of 42 randomized patients received an iontophoresis treatment in 1 qualifying eye and completed the study. Patients were randomized into 1 of 4 iontophoresis dose groups (1.6, 4.8, 10.0, or 14.0 mA-min), treated with EGP-437 via the EyeGate II Delivery System (EGDS), and followed until day 28.
MAIN OUTCOME MEASURES:
The main outcome measures were anterior chamber cell (ACC) scores at days 14 and 28; time to ACC score of zero; proportion of patients with an ACC score reduction from baseline of ≥0.5 at day 28; mean change from baseline in ACC score at day 28; and the systemic exposures of dexamethasone and dexamethasone phosphate after EGP-437 treatment with the EGDS.
RESULTS:
After a single EGP-437 treatment, 19 of 40 patients (48%) achieved an ACC score of zero at day 14. By day 28, 24 of 40 patients (60%) achieved an ACC score of zero. A Kaplan-Meier analysis demonstrated that the 1.6 mA-min dose was the most effective and revealed an inverse dose response; median days to an ACC score of zero were 11.5 days in the 1.6 mA-min group versus 31 days in the 14.0 mA-min group. Twenty-six patients (65%) had an ACC score reduction from baseline of ≥0.5 at day 28. The mean change in ACC score from baseline to day 28 was -2.14 with a median of -2.00. Throughout the study, the mean intraocular pressure remained within normal range and mean best-corrected visual acuity at 4 meters remained relatively stable. Most adverse events were mild; no serious adverse events were reported. Pharmacokinetics results showed low short-term systemic exposure to dexamethasone after iontophoresis; no nonocular systemic corticosteroid-mediated effects were observed.
CONCLUSIONS:
Approximately two thirds of the patients reached an ACC score of zero within 28 days, after only receiving 1 iontophoresis treatment. The lower doses seemed to be the most effective, and treatments were well-tolerated.
FINANCIAL DISCLOSURE(S):
Proprietary or commercial disclosure may be found after the references.
Copyright © 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
PMID: 22115712 [PubMed - as supplied by publisher]
LinkOut
Cohen AE, Assang C, Patane MA, From S, Korenfeld M; Avion Study Investigators.
Source
Eyegate Pharmaceuticals, Inc., Waltham, Massachusetts.
Abstract
PURPOSE:
Determine safe, effective, iontophoretic dose(s) of EGP-437 (dexamethasone phosphate formulated for iontophoresis) in patients with noninfectious anterior uveitis; evaluate systemic drug exposures.
DESIGN:
Prospective, phase I/II, multicenter, double-masked, parallel group, randomized clinical trial.
PARTICIPANTS:
Forty outpatients with anterior uveitis.
METHODS:
Forty of 42 randomized patients received an iontophoresis treatment in 1 qualifying eye and completed the study. Patients were randomized into 1 of 4 iontophoresis dose groups (1.6, 4.8, 10.0, or 14.0 mA-min), treated with EGP-437 via the EyeGate II Delivery System (EGDS), and followed until day 28.
MAIN OUTCOME MEASURES:
The main outcome measures were anterior chamber cell (ACC) scores at days 14 and 28; time to ACC score of zero; proportion of patients with an ACC score reduction from baseline of ≥0.5 at day 28; mean change from baseline in ACC score at day 28; and the systemic exposures of dexamethasone and dexamethasone phosphate after EGP-437 treatment with the EGDS.
RESULTS:
After a single EGP-437 treatment, 19 of 40 patients (48%) achieved an ACC score of zero at day 14. By day 28, 24 of 40 patients (60%) achieved an ACC score of zero. A Kaplan-Meier analysis demonstrated that the 1.6 mA-min dose was the most effective and revealed an inverse dose response; median days to an ACC score of zero were 11.5 days in the 1.6 mA-min group versus 31 days in the 14.0 mA-min group. Twenty-six patients (65%) had an ACC score reduction from baseline of ≥0.5 at day 28. The mean change in ACC score from baseline to day 28 was -2.14 with a median of -2.00. Throughout the study, the mean intraocular pressure remained within normal range and mean best-corrected visual acuity at 4 meters remained relatively stable. Most adverse events were mild; no serious adverse events were reported. Pharmacokinetics results showed low short-term systemic exposure to dexamethasone after iontophoresis; no nonocular systemic corticosteroid-mediated effects were observed.
CONCLUSIONS:
Approximately two thirds of the patients reached an ACC score of zero within 28 days, after only receiving 1 iontophoresis treatment. The lower doses seemed to be the most effective, and treatments were well-tolerated.
FINANCIAL DISCLOSURE(S):
Proprietary or commercial disclosure may be found after the references.
Copyright © 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
PMID: 22115712 [PubMed - as supplied by publisher]
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