Intermediate UveitisNCT00570830
Retisert and Cataract Surgery in Patients With Severe Uveitis
A study testing Retisert (fluocinolone acetonide implant) in people with Intermediate Uveitis and Posterior Uveitis, run by Duke University at 1 site in United States.
Trial summary
To review chart data at the Duke Eye Center and determined whether a 3-year fluocinolone acetonide sustained drug delivery system (FA) safely suppressed postoperative inflammation when combined with phacoemulsification and posterior chamber intraocular lens implantation (phaco/PCIOL) in eyes with severe uveitis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intermediate Uveitis, Posterior Uveitis
- What is being tested?
- Retisert (fluocinolone acetonide implant)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to May 2008
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A visually significant cataract
- A history of recurrent noninfectious posterior uveitis or intermediate uveitis with or without iridocyclitis
- incomplete therapeutic response or treatment-limiting side effects to oral, periocular corticosteroid, and/or immunosuppressive agents
- VA of at least light perception; and
- Ability to comprehend informed consent and comply with follow-up examinations
Who cannot join
- An allergy to fluocinolone acetonide or any component of the delivery system
- A toxoplasmosis scar was present in the study eye,
- A peripheral retinal detachment (RD) in the area of the planned fluocinolone acetonide implant placement
- Required chronic systemic corticosteroid therapy or systemic immunosuppressive therapy to treat non-ocular disease or if they tested positive for human immunodeficiency virus.
- Also excluded were female patients who were pregnant or lactating or not taking precautions to avoid pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 07710
About this study
Official title: Combined Fluocinolone Acetonide Sustained Drug Delivery System Implantation and Phacoemulsification/Intraocular Lens Implantation in Patients With Severe Uveitis
To review chart data at the Duke Eye Center and determined whether a 3-year fluocinolone acetonide sustained drug delivery system (FA) safely suppressed postoperative inflammation when combined with phacoemulsification and posterior chamber intraocular lens implantation (phaco/PCIOL) in eyes with severe uveitis.
Read the detailed description
Cataracts are common in eyes with uveitis. It results from inflammation or the use of topical or systemic steroids. Cataract surgery can cause an unusually severe inflammatory response, abnormal or excessive bleeding, and unexpected postoperative IOP responses such as hypertension or hypotony. Previous studies showed that successful outcome is preoperative and postoperative control of intraocular inflammation by topical, periocular, and systemic steroidal or immunosuppressive agents. In patients with severe posterior uveitis, periocular and intravitreal injections often provide only transient effects and are associated with complications such as hemorrhage, retinal detachment and endophthalmitis. Oral corticosteroid therapy are also associated with side effects to multiple organ systems in the body. A novel technology that delivers corticosteroid therapy linearly via an intravitreal, polymer-coated, sustained release implant has been developed and FDA approved to treat severe posterior segment uveitis. FA implantation effectively controls inflammation over an extended period of time in a complicated group of patients with posterior and/or panuveitis and allows reduced immunosuppression. We hope to determined whether this implant, a fluocinolone acetonide sustained drug delivery system (FA), can safely suppress postoperative inflammation when combined with phacoemulsification and posterior chamber intraocular lens implantation (phaco/PCIOL) in eyes with severe uveitis. We hypothesize that combining the implant with cataract surgery will provide better surgical outcomes by suppressing inflammation during the postoperative period. By reviewing our own surgical data at the Duke Eye Center, we intend to primarily focus on the safety and effectiveness of this surgical procedure.
- Conditions
- Intermediate Uveitis, Posterior Uveitis
- Being tested
- Retisert (fluocinolone acetonide implant)
- 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.
Retisert (fluocinolone acetonide implant)Device
Also called 1
Patients with intermediate, posterior or pan-uveitis underwent simultaneous fluocinolone acetonide implantation (0.59 mg or 2.1 mg) and phacoemulsification and intraocular lens.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | single armed case series in which all patients underwent the same treatment. Receives: Device: Retisert (fluocinolone acetonide implant) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative and postoperative ocular inflammation
Measured: up to 12 months postoperatively
Secondary outcomes (1)
visual acuity
Measured: up to 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2007 (estimated)
- Study startSep 2006
- Primary completionNov 2007
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intermediate UveitisStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Investigators
- Glenn J Jaffe, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00570830
- Sponsor's protocol ID
- 9145
- Other IDs
- 9145-06--10R0ER
- Status last verified
- Aug 2008
- First submitted
- 10 Dec 2007
- Last updated
- 3 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Foster CS, Fong LP, Singh G. Cataract surgery and intraocular lens implantation in patients with uveitis. Ophthalmology. 1989 Mar;96(3):281-8. doi: 10.1016/s0161-6420(89)32898-3.
PubMed 2629713Jaffe GJ, Martin D, Callanan D, Pearson PA, Levy B, Comstock T; Fluocinolone Acetonide Uveitis Study Group. Fluocinolone acetonide implant (Retisert) for noninfectious posterior uveitis: thirty-four-week results of a multicenter randomized clinical study. Ophthalmology. 2006 Jun;113(6):1020-7. doi: 10.1016/j.ophtha.2006.02.021. Epub 2006 May 9.
PubMed 16690128Chieh JJ, Carlson AN, Jaffe GJ. Combined fluocinolone acetonide intraocular delivery system insertion, phacoemulsification, and intraocular lens implantation for severe uveitis. Am J Ophthalmol. 2008 Oct;146(4):589-594. doi: 10.1016/j.ajo.2008.05.035. Epub 2008 Jul 17.
PubMed 18639220
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Fluocinolone Acetonide Sustained Drug Delivery System Implantation and Phacoemulsification/Intraocular Lens Implantation in Patients With Severe Uveitis
- ClinicalTrials.gov ID
- NCT00570830
- Acronym / sponsor ID
- 9145
- Conditions
- Intermediate Uveitis, Posterior Uveitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 11 Dec 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.
To review chart data at the Duke Eye Center and determined whether a 3-year fluocinolone acetonide sustained drug delivery system (FA) safely suppressed postoperative inflammation when combined with phacoemulsification and posterior chamber intraocular lens implantation (phaco/PCIOL) in eyes with severe uveitis.
Detailed description
Cataracts are common in eyes with uveitis. It results from inflammation or the use of topical or systemic steroids. Cataract surgery can cause an unusually severe inflammatory response, abnormal or excessive bleeding, and unexpected postoperative IOP responses such as hypertension or hypotony. Previous studies showed that successful outcome is preoperative and postoperative control of intraocular inflammation by topical, periocular, and systemic steroidal or immunosuppressive agents. In patients with severe posterior uveitis, periocular and intravitreal injections often provide only transient effects and are associated with complications such as hemorrhage, retinal detachment and endophthalmitis. Oral corticosteroid therapy are also associated with side effects to multiple organ systems in the body. A novel technology that delivers corticosteroid therapy linearly via an intravitreal, polymer-coated, sustained release implant has been developed and FDA approved to treat severe posterior segment uveitis. FA implantation effectively controls inflammation over an extended period of time in a complicated group of patients with posterior and/or panuveitis and allows reduced immunosuppression. We hope to determined whether this implant, a fluocinolone acetonide sustained drug delivery system (FA), can safely suppress postoperative inflammation when combined with phacoemulsification and posterior chamber intraocular lens implantation (phaco/PCIOL) in eyes with severe uveitis. We hypothesize that combining the implant with cataract surgery will provide better surgical outcomes by suppressing inflammation during the postoperative period. By reviewing our own surgical data at the Duke Eye Center, we intend to primarily focus on the safety and effectiveness of this surgical procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Device: Retisert (fluocinolone acetonide implant)single armed case series in which all patients underwent the same treatment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- A visually significant cataract
- A history of recurrent noninfectious posterior uveitis or intermediate uveitis with or without iridocyclitis
- incomplete therapeutic response or treatment-limiting side effects to oral, periocular corticosteroid, and/or immunosuppressive agents
- VA of at least light perception; and
- Ability to comprehend informed consent and comply with follow-up examinations
Key exclusion criteria (5 listed)
- An allergy to fluocinolone acetonide or any component of the delivery system
- A toxoplasmosis scar was present in the study eye,
- A peripheral retinal detachment (RD) in the area of the planned fluocinolone acetonide implant placement
- Required chronic systemic corticosteroid therapy or systemic immunosuppressive therapy to treat non-ocular disease or if they tested positive for human immunodeficiency virus.
- Also excluded were female patients who were pregnant or lactating or not taking precautions to avoid pregnancy.
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 |
|---|---|---|
| Retisert (fluocinolone acetonide implant)Also: 1Patients with intermediate, posterior or pan-uveitis underwent simultaneous fluocinolone acetonide implantation (0.59 mg or 2.1 mg) and phacoemulsification and intraocular lens. | Device | 1 |
Primary outcome
Preoperative and postoperative ocular inflammation
Time frame: up to 12 months postoperatively
1 secondary outcome
visual acuity
Time frame: up to 12 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2014.
- Background: PubMed 2629713Foster CS, Fong LP, Singh G. Cataract surgery and intraocular lens implantation in patients with uveitis. Ophthalmology. 1989 Mar;96(3):281-8. doi: 10.1016/s0161-6420(89)32898-3.
- Background: PubMed 16690128Jaffe GJ, Martin D, Callanan D, Pearson PA, Levy B, Comstock T; Fluocinolone Acetonide Uveitis Study Group. Fluocinolone acetonide implant (Retisert) for noninfectious posterior uveitis: thirty-four-week results of a multicenter randomized clinical study. Ophthalmology. 2006 Jun;113(6):1020-7. doi: 10.1016/j.ophtha.2006.02.021. Epub 2006 May 9.
- Derived from this study: PubMed 18639220Chieh JJ, Carlson AN, Jaffe GJ. Combined fluocinolone acetonide intraocular delivery system insertion, phacoemulsification, and intraocular lens implantation for severe uveitis. Am J Ophthalmol. 2008 Oct;146(4):589-594. doi: 10.1016/j.ajo.2008.05.035. Epub 2008 Jul 17.
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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.
Glenn J Jaffe, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retisert (fluocinolone acetonide implant) in people with Intermediate Uveitis and Posterior Uveitis, run by Duke University at 1 site in United States.
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 5 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 3 Sep 2014. 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 United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Preoperative and postoperative ocular inflammation (time frame: up to 12 months postoperatively). 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 NCT00570830, 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 3 Sep 2014.