Uveitis Clinical Trial
Official title:
A Phase I/IIa Study of the Treatment of None-Infectious Anterior, Intermediate, Posterior and Panuveitis, With the Use of Dexamethasone Delivered by a Iontophoresis Device
The multiple properties of the corticosteroids over the inflammatory response, make them first line drugs for the treatment of several ocular inflammatory disorders of different etiologies. In order to diminish the corticosteroids severe systemic adverse effects, the local administration is preferred. Iontophoresis already has been used in a successful way for the administration of corticosteroids. Clinical or histopathological injuries due to the use of transcleral CCI have not been observed. being successful the administration of methylprednisolone by means of this system in previous studies. The objective is to evaluate the tolerance, security and effectiveness of this treatment, using a new generation device.
The multiple properties of the corticosteroids on the inflammatory response, make them a
first line election in the treatment of several ocular inflammatory disorders of different
etiologies. Within its properties we can mention: the reestablishment of the vascular
permeability, decrease of the cellular infiltrated and the exudation of fibrin, alteration
of the activity of monocytes and neutrophils, decrease the proliferation of fibroblasts and
endothelial cells and diminish the neovascularization post inflammation (1). For that
reason, not only they diminish the inflammatory reaction, but they also diminish the
formation of permanent scar, that often is responsible for the visual loss (2,3).
The most severe systemic adverse effects of the corticosteroids are: systemic hyperglicemy,
the formation of gastric ulcers, avascular necrosis to of the head of the femur, suppression
of the hypothalamus-pituitary adrenal axis, arterial hypertension among others (21,22). In
order to diminish the severe systemic adverse effects of the corticosteroids, the local
administration is preferred (4). The subconjunctival injection or topical instillation,
reaches effective concentrations in the anterior chamber (5-7) whereas to reach these
concentrations in the posterior segment it requires a systemic, intravitreous or periocular
administration (8-11). Generally it require multiple injections, which produces patient
discomfort. In addition, after periocular administration, just a small fraction of the drug
penetrates the eye, whereas the rest is systemically absorbed, reason why the systemic
adverse effects are not avoided.
Iontophoresis already has been successful used for the administration of corticosteroids,
reaching high and lasting concentrations in both segments of the eye. (12-13). Remaining
with effective concentrations up to 40 to 60 hours after the administration (23). But,
Because focal chorioretinal injuries have been described, with the use of transcleral
Iontophoresis, using current of high densities (14-18), this method has not gain a space in
the current clinical practice. It has been previously demonstrated that the Controlled
Column Iontophoresis (CCI Eyegate, Optis France SA) was as effective as the intraperitoneal
administration of Dexamethasone for the treatment of the anterior and posterior uveitis
induced by endotoxins (19). Through control of the electrical parameters and using safer
settings, clinical or histopathological injuries due to the use of transcleral CCI have not
been observed (20). The results of a pre-clinical study, in which methylprednisolone
succinate by means of CCI was administered, demonstrated to be a safe method, reporting high
and lasting intraocular concentrations.
In addition, a study in France was elaborated, that included 89 patients with different
intraocular inflammatory diseases. Such as corneal graft rejections, previous uveitis,
postoperative endophthalmitis, macular edema and inflammations of the posterior segment. For
the evaluation of the security and effectiveness of the administration of methylprednisolone
by means of CCI. The patients were enlisted if they required periocular or systemic
treatment due to the failure of maximal topical therapy. The average of treatment with
Iontophoresis was of 2,7 +/- 0,9 (1-5), with an current intensity of 1,2 to 2mA and duration
of 2 to 5 minutes of each treatment.
A significant increase of conjunctival hyperemia was observed, subsequent to each CCI, which
spontaneous resolved. There were no related adverse Effects. Still more, it was observed an
increase of the visual acuity and decrease of the clinical inflammation in this group of
patients. No of the patients loss vision and the inflammation biomarkers, taken like a
whole, continued improving up to 30 days after the treatment.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04101604 -
Biomarkers of Common Eye Diseases
|
||
Active, not recruiting |
NCT04704609 -
Imaging Quantification of Inflammation (IQI)
|
||
Completed |
NCT03173144 -
Chronic Inflammatory Disease, Lifestyle and Treatment Response
|
||
Withdrawn |
NCT01280669 -
Intravitreal Sirolimus as Therapeutic Approach to Uveitis
|
Phase 2 | |
Terminated |
NCT02907814 -
Measurement of Anterior Chamber Cell Grading Using Ocular Coherence Tomography
|
N/A | |
Active, not recruiting |
NCT02252328 -
Use of Simvastatin as a Steroid Sparing Agent for Uveitis Patients
|
Phase 2/Phase 3 | |
Completed |
NCT04183387 -
Simvastatin in Uveitis
|
Phase 2 | |
Completed |
NCT01983488 -
Clinical Outcome in Uveitis
|
||
Completed |
NCT00476593 -
Retinal OCT and (mfERG) Related to Age, Sex, and the Use of Anti-inflammatory Medications
|
N/A | |
Completed |
NCT00132691 -
Multicenter Uveitis Steroid Treatment (MUST) Trial
|
Phase 4 | |
Terminated |
NCT00114062 -
Study to Treat Uveitis Associated Macular Edema
|
Phase 2 | |
Completed |
NCT00001867 -
Effect of Pregnancy on Uveitis
|
N/A | |
Completed |
NCT00379275 -
Eye and Immunogenetic Features of Sarcoidosis
|
N/A | |
Active, not recruiting |
NCT03828019 -
Adalimumab vs. Conventional Immunosuppression for Uveitis Trial
|
Phase 3 | |
Terminated |
NCT01939691 -
Macular Edema Nepafenac vs. Difluprednate Uveitis Trial
|
Phase 4 | |
Active, not recruiting |
NCT03889860 -
Objective Choroidal Thickness Measurements in Uveitis
|
||
Completed |
NCT00070759 -
Daclizumab to Treat Non-Infectious Sight-Threatening Uveitis
|
Phase 2 | |
Recruiting |
NCT05486468 -
The Use of Two YUTIQ Versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment
|
Phase 3 | |
Active, not recruiting |
NCT05385757 -
UNICORNS: Uveitis in Childhood Prospective National Cohort Study
|
||
Active, not recruiting |
NCT06260449 -
Different Treatment Approaches of Presumed Trematode-Induced Uveitis
|
N/A |