Intermediate UveitisPhase 2/3NCT00333814
A Study of the Safety and Efficacy of a New Treatment for Non-Infectious Intermediate or Posterior Uveitis
A Phase 2/3 study testing Dexamethasone in people with Intermediate Uveitis and Posterior Uveitis, run by Allergan at 18 sites in 18 countries.
Trial summary
This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of non-infectious intermediate or posterior uveitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intermediate Uveitis, Posterior Uveitis
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 229 participants
- Where
- 18 sitesin 18 countries
- Study dates
- May 2006to Apr 2009
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older with a diagnosis of chronic intermediate uveitis in at least one eye
Who cannot join
- Uncontrolled systemic disease
- Any active ocular infections
Trial locations and contacts
18 sites in 18 countries.
18 sites in 18 countries
About this study
This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of non-infectious intermediate or posterior uveitis.
- Conditions
- Intermediate Uveitis, Posterior Uveitis
- Being tested
- Dexamethasone, Sham injection
- Medical subject headings
- Uveitis, Intermediate, Uveitis, Posterior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Posurdex®
Dexamethasone 350 µg; injection drug delivery system at Day 0
dexamethasoneDrug
Also called Posurdex®
Dexamethasone 700 µg injection drug delivery system at Day 0
Sham injectionDrug
Sham injection at Day 0
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Dexamethasone 350 µg Receives: Drug: Dexamethasone |
| 2 | Active comparator | Dexamethasone 700 µg Receives: Drug: dexamethasone |
| 3 | Sham comparator | Sham Receives: Drug: Sham injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With Vitreous Haze (Ocular Inflammation) Score of Zero
Percentage of patients with Vitreous Haze Score of Zero at Week 8. Score is based on standardized scale of 0 to +4 where 0 equals no inflammation and +4 equals optic nerve head not visible (severe).
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2006 (estimated)
- Study startMay 2006
- Primary completionDec 2008
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intermediate 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00333814
- Sponsor's protocol ID
- 206207-014
- Status last verified
- Mar 2011
- First submitted
- 2 Jun 2006
- Last updated
- 14 Apr 2011
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Lightman S, Belfort R Jr, Naik RK, Lowder C, Foster CS, Rentz AM, Cui H, Whitcup SM, Kowalski JW, Revicki DA. Vision-related functioning outcomes of dexamethasone intravitreal implant in noninfectious intermediate or posterior uveitis. Invest Ophthalmol Vis Sci. 2013 Jul 18;54(7):4864-70. doi: 10.1167/iovs.12-10981.
PubMed 23761087Naik RK, Rentz AM, Foster CS, Lightman S, Belfort R Jr, Lowder C, Whitcup SM, Kowalski JW, Revicki DA. Normative comparison of patient-reported outcomes in patients with noninfectious uveitis. JAMA Ophthalmol. 2013 Feb;131(2):219-25. doi: 10.1001/2013.jamaophthalmol.102.
PubMed 23411886Lowder C, Belfort R Jr, Lightman S, Foster CS, Robinson MR, Schiffman RM, Li XY, Cui H, Whitcup SM; Ozurdex HURON Study Group. Dexamethasone intravitreal implant for noninfectious intermediate or posterior uveitis. Arch Ophthalmol. 2011 May;129(5):545-53. doi: 10.1001/archophthalmol.2010.339. Epub 2011 Jan 10.
PubMed 21220619
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Safety and Efficacy of a New Treatment for Non-Infectious Intermediate or Posterior Uveitis
- ClinicalTrials.gov ID
- NCT00333814
- Acronym / sponsor ID
- 206207-014
- Conditions
- Intermediate Uveitis, Posterior Uveitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 6 Jun 2006 (estimated)
- Results
- Posted 14 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of non-infectious intermediate or posterior uveitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: DexamethasoneDexamethasone 350 µg |
| 2 | Active comparator | Drug: dexamethasoneDexamethasone 700 µg |
| 3 | Sham comparator | Drug: Sham injectionSham |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years or older with a diagnosis of chronic intermediate uveitis in at least one eye
Key exclusion criteria (2 listed)
- Uncontrolled systemic disease
- Any active ocular infections
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 |
|---|---|---|
| DexamethasoneAlso: Posurdex®Dexamethasone 350 µg; injection drug delivery system at Day 0 | Drug | 1 |
| dexamethasoneAlso: Posurdex®Dexamethasone 700 µg injection drug delivery system at Day 0 | Drug | 2 |
| Sham injectionSham injection at Day 0 | Drug | 3 |
Primary outcome
Percentage of Patients With Vitreous Haze (Ocular Inflammation) Score of Zero
Time frame: Week 8
Percentage of patients with Vitreous Haze Score of Zero at Week 8. Score is based on standardized scale of 0 to +4 where 0 equals no inflammation and +4 equals optic nerve head not visible (severe).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23761087Lightman S, Belfort R Jr, Naik RK, Lowder C, Foster CS, Rentz AM, Cui H, Whitcup SM, Kowalski JW, Revicki DA. Vision-related functioning outcomes of dexamethasone intravitreal implant in noninfectious intermediate or posterior uveitis. Invest Ophthalmol Vis Sci. 2013 Jul 18;54(7):4864-70. doi: 10.1167/iovs.12-10981.
- Derived from this study: PubMed 23411886Naik RK, Rentz AM, Foster CS, Lightman S, Belfort R Jr, Lowder C, Whitcup SM, Kowalski JW, Revicki DA. Normative comparison of patient-reported outcomes in patients with noninfectious uveitis. JAMA Ophthalmol. 2013 Feb;131(2):219-25. doi: 10.1001/2013.jamaophthalmol.102.
- Derived from this study: PubMed 21220619Lowder C, Belfort R Jr, Lightman S, Foster CS, Robinson MR, Schiffman RM, Li XY, Cui H, Whitcup SM; Ozurdex HURON Study Group. Dexamethasone intravitreal implant for noninfectious intermediate or posterior uveitis. Arch Ophthalmol. 2011 May;129(5):545-53. doi: 10.1001/archophthalmol.2010.339. Epub 2011 Jan 10.
- Related InfoLink provided by the sponsor.
Related trials for Intermediate Uveitis
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A Clinical Trial Of Tulisokibart In Participants With Active, Non-Infectious Uveitis (MK-7240-019)
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Adalimumab Dose Adjustment for Pediatric Uveitis Treatment Trial
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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.
Medical Director study director
Allergan
18 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dexamethasone in people with Intermediate Uveitis and Posterior Uveitis, run by Allergan at 18 sites in 18 countries.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 14 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Australia, Austria, Brazil, Canada and 13 more countries. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Patients With Vitreous Haze (Ocular Inflammation) Score of Zero (time frame: Week 8). 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 NCT00333814, which also lists 3 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 14 Apr 2011.