UveitisPhase 1/2NCT00499551
A Phase I/IIa Study for the Treatment of Uveitis With Iontophoresis
A Phase 1/2 study testing Iontophoresis second generation Eyegate II device in people with Uveitis, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 90 years
- Conditions the study is for
- Uveitis
- What is being tested?
- Iontophoresis second generation Eyegate II device
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- Sep 2007to Sep 2009
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Asociación para Evitar la Ceguera en Mexico
Mexico City, Mexico City, 04030
About this study
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.
Read the detailed description
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.
- Conditions
- Uveitis
- Being tested
- Iontophoresis second generation Eyegate II device
- Keywords
- Anterior Uveitis, Posterior Uveitis, Intermediate Uveitis, Panuveitis, Iontophoresis, Dexamethasone
- Medical subject headings
- Uveitis, Uveitis, Anterior, Uveitis, Posterior, Uveitis, Intermediate, Panuveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iontophoresis second generation Eyegate II deviceDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
to assess the tolerance, security and effectiveness in the treatment of different intraocular inflammatory disease
Measured: two years
Secondary outcomes (4)
To establish the Iontophoresis utility in the drug administration in the treatment of the IID
Measured: two years
To establish the effectiveness of the CCI with Dexamethasone in the IID control
Measured: two years
To establish the security of the Dexamethasone administration with CCI in the treatment of the IID
Measured: two years
To establish the time in which the control of the ocular inflammation is succeed when using the CCI with Dexamethasone.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2007 (estimated)
- Study startSep 2007
- Primary completionSep 2007
- Study completionSep 2009
Why it stopped: The drug needed for the study is not available in Mexico anymore.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for UveitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asociación para Evitar la Ceguera en México
- Sponsor type
- University, hospital or other
- Investigators
- Hugo Quiroz-Mercado, MD, Principal investigator, Asociación para Evitar la Ceguera en MexicoLourdes Arellanes, MD, Principal investigator, Asociación para Evitar la Ceguera en MexicoRaul Velez-Montoya, MD, Study director, Asociación para Evitar la Ceguera en Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00499551
- Sponsor's protocol ID
- Iontophoresis001
- Status last verified
- May 2024
- First submitted
- 9 Jul 2007
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cole HP, Stallman J. Diamon DJ. High Dose Intravitreal Dexamethasone for Infections Endophthalmitis. Invest Ophthalmol Visc Sci. 1989;30:509-512.
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.
PubMed 1485018Stanbury 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.
PubMed 9797677Leibowitz 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.
PubMed 836214MCCARTNEY 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.
PubMed 14326615Benson 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.
PubMed 4621283Barry 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.
PubMed 5822457Bodker 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.
PubMed 8351091Weijtens 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.
PubMed 9063245Weijtens 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.
PubMed 9625551Lachaud 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.
PubMed 5827464Lam 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.
PubMed 2783069Lam 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.
PubMed 1916328Barza 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.
PubMed 3951811Barza M, Peckman C, Baum J. Transscleral iontophoresis of gentamicin in monkeys. Invest Ophthalmol Vis Sci. 1987 Jun;28(6):1033-6.
PubMed 3583629
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00499551
- Acronym / sponsor ID
- Iontophoresis001
- Conditions
- Uveitis
- Keywords
- Anterior Uveitis, Posterior Uveitis, Intermediate Uveitis, Panuveitis, Iontophoresis, Dexamethasone
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The drug needed for the study is not available in Mexico anymore.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Asociación para Evitar la Ceguera en MéxicoUniversity, hospital or other
- Study start
- Sep 2007 (actual)
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 11 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 15 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iontophoresis second generation Eyegate II device | Device | – |
Primary outcome
to assess the tolerance, security and effectiveness in the treatment of different intraocular inflammatory disease
Time frame: two years
4 secondary outcomes
To establish the Iontophoresis utility in the drug administration in the treatment of the IID
Time frame: two years
To establish the effectiveness of the CCI with Dexamethasone in the IID control
Time frame: two years
To establish the security of the Dexamethasone administration with CCI in the treatment of the IID
Time frame: two years
To establish the time in which the control of the ocular inflammation is succeed when using the CCI with Dexamethasone.
Time frame: two years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- BackgroundCole HP, Stallman J. Diamon DJ. High Dose Intravitreal Dexamethasone for Infections Endophthalmitis. Invest Ophthalmol Visc Sci. 1989;30:509-512.
- Background: PubMed 1485018Schulman 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.
- Background: PubMed 9797677Stanbury 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.
- Background: PubMed 836214Leibowitz 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.
- Background: PubMed 14326615MCCARTNEY 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.
- Background: PubMed 4621283Benson 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.
- Background: PubMed 5822457Barry 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.
- Background: PubMed 8351091Bodker 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.
- Background: PubMed 9063245Weijtens 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.
- Background: PubMed 9625551Weijtens 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.
- Background: PubMed 5827464Lachaud 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.
- Background: PubMed 2783069Lam 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hugo Quiroz-Mercado, MD principal investigator
Asociación para Evitar la Ceguera en Mexico
Lourdes Arellanes, MD principal investigator
Asociación para Evitar la Ceguera en Mexico
Raul Velez-Montoya, MD study director
Asociación para Evitar la Ceguera en Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Iontophoresis second generation Eyegate II device in people with Uveitis, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to assess the tolerance, security and effectiveness in the treatment of different intraocular inflammatory disease (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00499551, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.