A Phase I/IIa Study for the Treatment of Uveitis With Iontophoresis

NCT00499551 | Withdrawn Phase 1 DMC

• 1 other identifier: Iontophoresis001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Uveitis

Keywords

Anterior Uveitis; Posterior Uveitis; Intermediate Uveitis; Panuveitis; Iontophoresis; Dexamethasone

Outcome Measures

Primary Outcomes (1)

• to assess the tolerance, security and effectiveness in the treatment of different intraocular inflammatory disease

  two years

Secondary Outcomes (4)

• To establish the Iontophoresis utility in the drug administration in the treatment of the IID

  two years

• To establish the effectiveness of the CCI with Dexamethasone in the IID control

  two years

• To establish the security of the Dexamethasone administration with CCI in the treatment of the IID

  two years

• To establish the time in which the control of the ocular inflammation is succeed when using the CCI with Dexamethasone.

  two years

Interventions

Iontophoresis second generation Eyegate II device DEVICE

Eligibility Criteria

• Age: 15 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical history of, none-infectious anterior, intermediate, posterior or panuveitis, with or without associate systemic disease, like: Vogt Koyanagi Harada, Wegener Granulomatosis, Systemic erythematous Lupus, Behçet disease, etc.
• Requirement or with current topical treatment with steroids (more than every 6 hours), needs acute or chronic treatment with oral, intravenous, periocular or intravitreous corticosteroids or immunosuppressive agents for the control of the disease.
• Best Corrected Visual Acuity in the worse eye of 20/40 to 20/800 in ETDRS record.
• Patients with good mydriasis and no significant ocular opacities.
• Patients who do not plan elective surgery.

You may not qualify if:

• Infectious, pos-traumatic, Fuchs or self-limited uveitis. Patients with Diagnosis of glaucoma or ocular hypertension (greater than 25mmHg).
• Diagnosis or suspects ocular or central nervous system lymphoma. Patients with only one eye.
• Associated optical Neuritis of any etiology.
• Severe injuries in the eyelids or in the ocular surface that prevent the application of the electrode.
• Well-known allergy to the Dexamethasone.
• Toxoplasma scar or vitreous hemorrhage.
• Corneal injuries of herpetic origin or with suspicion of being herpetic.
• Patients with poor mydriasis, significant ocular opacities that prevents the evaluation of the posterior pole or the follow-up studies.

Sponsors & Collaborators

• Asociación para Evitar la Ceguera en México: lead

Study Sites (1)

Asociación para Evitar la Ceguera en Mexico

Mexico City, Mexico City, 04030, Mexico

Location

Related Publications (15)

• Cole HP, Stallman J. Diamon DJ. High Dose Intravitreal Dexamethasone for Infections Endophthalmitis. Invest Ophthalmol Visc Sci. 1989;30:509-512.

  BACKGROUND

• Schulman JA, Peyman GA. Intravitreal corticosteroids as an adjunct in the treatment of bacterial and fungal endophthalmitis. A review. Retina. 1992;12(4):336-40. doi: 10.1097/00006982-199212040-00007.

  PMID: 1485018 BACKGROUND

• Stanbury RM, Graham EM. Systemic corticosteroid therapy--side effects and their management. Br J Ophthalmol. 1998 Jun;82(6):704-8. doi: 10.1136/bjo.82.6.704.

  PMID: 9797677 BACKGROUND

• Leibowitz HM, Kupferman A. Periocular injection of corticosteroids: an experimental evaluation of its role in the treatment of corneal inflammation. Arch Ophthalmol. 1977 Feb;95(2):311-4. doi: 10.1001/archopht.1977.04450020112019.

  PMID: 836214 BACKGROUND

• MCCARTNEY HJ, DRYSDALE IO, GORNALL AG, BASU PK. AN AUTORADIOGRAPHIC STUDY OF THE PENETRATION OF SUBCONJUNCTIVALLY INJECTED HYDROCORTISONE INTO THE NORMAL AND INFLAMED RABBIT EYE. Invest Ophthalmol. 1965 Jun;4:297-302. No abstract available.

  PMID: 14326615 BACKGROUND

• Benson H. Permeability of the cornea to topically applied drugs. Arch Ophthalmol. 1974 Apr;91(4):313-27. doi: 10.1001/archopht.1974.03900060323017. No abstract available.

  PMID: 4621283 BACKGROUND

• Barry A, Rousseau A, Babineau LM. The penetration of steroids into the rabbit's vitreous, choroid and retina following retrobulbar injection. I. Can J Ophthalmol. 1969 Oct;4(4):365-9. No abstract available.

  PMID: 5822457 BACKGROUND

• Bodker FS, Ticho BH, Feist RM, Lam TT. Intraocular dexamethasone penetration via subconjunctival or retrobulbar injections in rabbits. Ophthalmic Surg. 1993 Jul;24(7):453-7.

  PMID: 8351091 BACKGROUND

• Weijtens O, van der Sluijs FA, Schoemaker RC, Lentjes EG, Cohen AF, Romijn FP, van Meurs JC. Peribulbar corticosteroid injection: vitreal and serum concentrations after dexamethasone disodium phosphate injection. Am J Ophthalmol. 1997 Mar;123(3):358-63. doi: 10.1016/s0002-9394(14)70131-x.

  PMID: 9063245 BACKGROUND

• Weijtens O, Schoemaker RC, Cohen AF, Romijn FP, Lentjes EG, van Rooij J, van Meurs JC. Dexamethasone concentration in vitreous and serum after oral administration. Am J Ophthalmol. 1998 May;125(5):673-9. doi: 10.1016/s0002-9394(98)00003-8.

  PMID: 9625551 BACKGROUND

• Lachaud JP. [Considerations on the use of corticoids by ionization in certain ocular diseases]. Bull Soc Ophtalmol Fr. 1965 Jan;65(1):84-9. No abstract available. French.

  PMID: 5827464 BACKGROUND

• Lam TT, Edward DP, Zhu XA, Tso MO. Transscleral iontophoresis of dexamethasone. Arch Ophthalmol. 1989 Sep;107(9):1368-71. doi: 10.1001/archopht.1989.01070020438050.

  PMID: 2783069 BACKGROUND

• Lam TT, Fu J, Tso MO. A histopathologic study of retinal lesions inflicted by transscleral iontophoresis. Graefes Arch Clin Exp Ophthalmol. 1991;229(4):389-94. doi: 10.1007/BF00170699.

  PMID: 1916328 BACKGROUND

• Barza M, Peckman C, Baum J. Transscleral iontophoresis of cefazolin, ticarcillin, and gentamicin in the rabbit. Ophthalmology. 1986 Jan;93(1):133-9. doi: 10.1016/s0161-6420(86)33780-1.

  PMID: 3951811 BACKGROUND

• Barza M, Peckman C, Baum J. Transscleral iontophoresis of gentamicin in monkeys. Invest Ophthalmol Vis Sci. 1987 Jun;28(6):1033-6.

  PMID: 3583629 BACKGROUND

MeSH Terms

Conditions

Uveitis; Uveitis, Anterior; Uveitis, Posterior; Uveitis, Intermediate; Panuveitis

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Study Officials

• Hugo Quiroz-Mercado, MD

  Asociación para Evitar la Ceguera en Mexico

  PRINCIPAL INVESTIGATOR

• Lourdes Arellanes, MD

  Asociación para Evitar la Ceguera en Mexico

  PRINCIPAL INVESTIGATOR

• Raul Velez-Montoya, MD

  Asociación para Evitar la Ceguera en Mexico

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 9, 2007
• First Posted: July 11, 2007
• Study Start: September 1, 2007
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2009
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

ME (1)