UveitisPhase 2NCT00615693
Safety, Tolerability, and Efficacy of AEB071 in the Treatment of Uveitis
A Phase 2 study testing AEB071 in people with Uveitis and Posterior Uveitis, run by Novartis at 13 sites in United States.
Trial summary
The purpose of this study is to assess the safety, tolerability, and efficacy of AEB071 as a therapy for uveitis. Vision improvement and reduction in the swelling of retina will be measured for the assessment of efficacy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Uveitis, Posterior Uveitis, Panuveitis
- What is being tested?
- AEB071
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 13 sitesUnited States
- Study dates
- Jul 2008to Oct 2009
- Phase
- Phase 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients with non-infectious intermediate or posterior uveitis or panuveitis in at least one eye, age 18 to 70 years of age inclusive, who are otherwise in good health
- Macular edema with average central retinal thickness ≥ 250 µm
- A vitreous haze score ≥ 1, but ≤ 3 (based on the National Eye Institute grading system)
- Best Corrected Visual Acuity no worse than 20/400 and no better than 20/40
- Daily prednisone dose < 1 mg/kg
Who cannot join
- Patients with choroidal neovascularization.
- Patients with the following forms of uveitis:
- Serpiginous choroidopathy
- Acute multifocal placoid pigment epitheliopathy
- White dot retino-choroidopathies (e.g., multiple evanescent white dot syndrome (MEWDS) or multifocal choroiditis)
- Macular edema associated with other ocular disease (e.g., diabetic retinopathy)
Show all 11Show fewer
- Patients who had a prior vitrectomy
- Any eye condition that may affect the evaluation of visual acuity and retinal thickness
- Concurrent use of certain immunosuppressive agents (specific washout periods for different agents are defined in the protocol)
- Use of systemic medications known to be toxic to the lens, retina, or optic nerve (e.g. deferoxamine, chloroquine, and ethambutol) currently or in the past 6 months
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Emory University
Atlanta, Georgia, 30322
Retina Research Centre
Austin, Texas, 78705
John Hopkins Hospital/Wilmer Eye Institute
Baltimore, Maryland, 21287
MERSI
Cambridge, Massachusetts, 02142
Colorado Retina Associates
Denver, Colorado, 80230
Vitreoretinal Consultants
Houston, Texas, 77030
University of Southern California Doheny Eye Institute
Los Angeles, California, 90033
University of Miami Miller School of Medicine; Anne Bates Leach Eye Hosptial;Bascom Palmer Eye Institute
Miami, Florida, 33136
New York Eye and Ear Infirmary, Clinical Research Department
New York, New York, 10003
Mayo Clinic Department of Opthalmology
Rochester, Minnesota, 55905
University of California
San Francisco, California, 94143
University of South Florida, Eye Institute
Tampa, Florida, 33612
Cornea and Laser Eye Institute
Teaneck, New Jersey, 07666
About this study
Official title: A Multicenter, Single Sequence, Open-label Study to Assess the Tolerability, Safety, and Efficacy of 2 Weeks Oral AEB071 300 mg Twice Daily, Followed by 6 Weeks AEB071 200 mg Twice Daily in the Treatment of Patients With Macular Edema Associated With Non-infectious Intermediate Uveitis, Posterior Uveitis, or Panuveitis
The purpose of this study is to assess the safety, tolerability, and efficacy of AEB071 as a therapy for uveitis. Vision improvement and reduction in the swelling of retina will be measured for the assessment of efficacy.
- Conditions
- Uveitis, Posterior Uveitis, Panuveitis
- Being tested
- AEB071
- Keywords
- Uveitis, Macular Edema
- Medical subject headings
- Uveitis, Uveitis, Posterior, Panuveitis, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AEB071Drug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: AEB071 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of AEB071
Measured: Baseline/Day 1 to Week 8 (Day 56) (end of study)
Secondary outcomes (3)
Change in the degree of inflammation in the study eye
Measured: Baseline/Day 1, Week 8 (Day 56)/end of study
Change in the visual acuity of the study eye
Measured: Baseline/Day 1, Week 8 (Day 56)/end of study
Change in macular edema in the study eye
Measured: Baseline/Day 1, Week 8 (Day 56)/end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2008 (estimated)
- Study startJul 2008
- Primary completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis, Principal investigator, Novartis investigator site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00615693
- Sponsor's protocol ID
- CAEB071A2211
- Status last verified
- Feb 2017
- First submitted
- 1 Feb 2008
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single Sequence, Open-label Study to Assess the Tolerability, Safety, and Efficacy of 2 Weeks Oral AEB071 300 mg Twice Daily, Followed by 6 Weeks AEB071 200 mg Twice Daily in the Treatment of Patients With Macular Edema Associated With Non-infectious Intermediate Uveitis, Posterior Uveitis, or Panuveitis
- ClinicalTrials.gov ID
- NCT00615693
- Acronym / sponsor ID
- CAEB071A2211
- Conditions
- Uveitis, Posterior Uveitis, Panuveitis
- Keywords
- Uveitis, Macular Edema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Oct 2009 (actual)
- First posted
- 14 Feb 2008 (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 purpose of this study is to assess the safety, tolerability, and efficacy of AEB071 as a therapy for uveitis. Vision improvement and reduction in the swelling of retina will be measured for the assessment of efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AEB071 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female patients with non-infectious intermediate or posterior uveitis or panuveitis in at least one eye, age 18 to 70 years of age inclusive, who are otherwise in good health
- Macular edema with average central retinal thickness ≥ 250 µm
- A vitreous haze score ≥ 1, but ≤ 3 (based on the National Eye Institute grading system)
- Best Corrected Visual Acuity no worse than 20/400 and no better than 20/40
- Daily prednisone dose < 1 mg/kg
Key exclusion criteria (11 listed)
- Patients with choroidal neovascularization.
- Patients with the following forms of uveitis:
- Macular edema associated with other ocular disease (e.g., diabetic retinopathy)
- Patients who had a prior vitrectomy
- Any eye condition that may affect the evaluation of visual acuity and retinal thickness
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 |
|---|---|---|
| AEB071 | Drug | 1 |
Primary outcome
Safety and tolerability of AEB071
Time frame: Baseline/Day 1 to Week 8 (Day 56) (end of study)
3 secondary outcomes
Change in the degree of inflammation in the study eye
Time frame: Baseline/Day 1, Week 8 (Day 56)/end of study
Change in the visual acuity of the study eye
Time frame: Baseline/Day 1, Week 8 (Day 56)/end of study
Change in macular edema in the study eye
Time frame: Baseline/Day 1, Week 8 (Day 56)/end of study
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 22 Dec 2020.
- Results for CAEB071A2211 from the Novartis Clinical Trials website.Link provided by the sponsor.
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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.
Novartis principal investigator
Novartis investigator site
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AEB071 in people with Uveitis and Posterior Uveitis, run by Novartis at 13 sites 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 11 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 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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.
What does this 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.
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 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?
Safety and tolerability of AEB071 (time frame: Baseline/Day 1 to Week 8 (Day 56) (end of study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Dec 2020.