UveitisPhase 2SARILNIUSATURNNCT01900431
Phase II Study to Analyze Sarilumab in Non-Infectious Uveitis
A Phase 2 study testing Sarilumab, Prednisone and Methotrexate in people with Uveitis, run by Sanofi at 20 sites in 6 countries.
Trial summary
Primary Objective: To evaluate the efficacy of sarilumab at Week 16 in participants with non-infectious uveitis (NIU). Secondary Objectives: To evaluate the change in best corrected visual acuity (BCVA). To evaluate the safety of subcutaneous sarilumab in participants with NIU. To evaluate the change in macular edema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitis
- What is being tested?
- Sarilumab, Prednisone and Methotrexate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 20 sitesin 6 countries
- Study dates
- Oct 2013to Apr 2016
- Phase
- Phase 2
- 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 of age.
- Non-infectious intermediate, posterior, or pan-uveitis in the study eye.
- Active disease at screening or evidence of activity within the 3 months prior to screening visit. Following the approval of amendment-2, only participants with "active disease" as defined above were enrolled in the study.
- Starting oral prednisone dose must be greater than or equal to 15 mg/day and less than 80 mg/day.
- At screening, participants must be receiving oral prednisone (≥15 mg and <80 mg/day [or equivalent oral corticosteroid]) as single immunosuppressive therapy or in combination with MTX (≤25 mg/week) orally or intravenously or intramuscular or subcutaneous). -
- Participants could be receiving one or several of the following therapies: Azathioprine (≤2.5 mg/kg/day), Mycophenolate mofetil (≤2 g daily, orally), Cyclosporine (≤4 mg/kg daily, orally), Tacrolimus (≤4 mg daily, orally).
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- The doses might not had been increased for at least 4 weeks prior to the randomization visit.
- At randomization, participants had been receiving oral prednisone (≥15 mg and <80 mg/day [or equivalent oral corticosteroid]) as single immunosuppressive therapy or in combination with MTX (≤25 mg/week) orally or intravenously or intramuscular or subcutaneous).
- Azathioprine, mycophenolate mofetil, cyclosporine and tacrolimus had to be permanently discontinued at least 48 hours prior to the first study treatment injection, or longer as per Investigator's judgment. These immunomodulatory therapies (IMTs) were not permitted anytime during the treatment period.
- Signed written informed consent.
Who cannot join
- Participants with best-corrected visual acuity (BCVA) worse than 20 early treatment diabetic retinopathy study (ETDRS) letters in at least one eye.
- Participants with confirmed or suspected uveitis of infectious etiology or uveitis of traumatic etiology.
- Participants with primary diagnosis of anterior uveitis.
- Prior treatment with anti-interleukin-6 (IL-6) or interleukin-6 receptor complex (IL-6R) antagonist therapies, including tocilizumab and sarilumab.
- The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Trial locations and contacts
20 sites in 6 countries.
20 sites in 6 countries
Turkey (Türkiye)6 sites
Investigational Site Number 792001
Ankara, 06100
Investigational Site Number 792005
Ankara, 06100
Investigational Site Number 792002
Istanbul, 34093
Investigational Site Number 792003
Istanbul, 34098
Investigational Site Number 792004
Izmir, 35100
Investigational Site Number 792006
Izmir, 35100
United States5 sites
Investigational Site Number 840006
Arlington, Texas, 76012
Investigational Site Number 840007
Cleveland, Ohio, 44195
Investigational Site Number 840009
Omaha, Nebraska, 68198-5540
Investigational Site Number 840005
Slingerlands, New York, 12159
Investigational Site Number 840008
Worcester, Massachusetts, 01608
Italy3 sites
Investigational Site Number 380001
Milan, 20132
Investigational Site Number 380003
Padova, 35128
Investigational Site Number 380004
Reggio Emilia, 42100
Czechia2 sites
Investigational Site Number 203001
Brno, 62500
Investigational Site Number 203002
Prague, 12808
France2 sites
Investigational Site Number 250001
Paris, 75013
Investigational Site Number 250002
Paris, 75571
Spain2 sites
Investigational Site Number 724003
Barcelona, 08028
Investigational Site Number 724001
Barcelona, 08907
About this study
Official title: A Randomized, Double-Masked and Placebo-Controlled Study to Evaluate the Efficacy and Safety of Sarilumab Administered Subcutaneously Every 2 Weeks in Patients With Non-Infectious, Intermediate, Posterior or Pan-Uveitis (NIU)
Primary Objective:
To evaluate the efficacy of sarilumab at Week 16 in participants with non-infectious uveitis (NIU).
Read more
Secondary Objectives:
To evaluate the change in best corrected visual acuity (BCVA). To evaluate the safety of subcutaneous sarilumab in participants with NIU. To evaluate the change in macular edema. To evaluate the change in other signs of ocular inflammation. To evaluate the effect on retinal vessel leakage. To evaluate the effect of sarilumab on reducing concomitant immunosuppressant therapy.
To evaluate the change in ocular inflammation in the anterior chamber. To evaluate the pharmacokinetics of sarilumab in NIU participants. To evaluate the immunogenicity with anti-drug antibodies (ADA).
Read the detailed description
The total duration per participant was up to 58 weeks, which included a 2 week screening period, 16 weeks principal treatment period (Part A), 34 weeks extension treatment period (Part B) or open label treatment period (Part C), and 6 weeks after last treatment administration.
Participants with decrease in vitreous haze (VH) ≥2; or corticosteroids dose <10 mg/day at Week 16 were considered as responders. Participants who did not complete the principal treatment period (Part A) due to lack of efficacy; or no decrease in VH ≥2 and corticosteroids dose ≥10 mg/day at Week 16; or no decrease in VH ≥2 and corticosteroids dose missing at Week 16; or non-responder according to medical review, were considered as non-responders.
Responder participants, observed at Week 16 (at the end of Part A), were invited to continue in the extension treatment period (Part B).
Non-responder participants, observed within the first 16 weeks, were offered to be treated by open-label sarilumab (Part C).
- Conditions
- Uveitis
- Being tested
- Sarilumab, Prednisone, Methotrexate, Folic/folinic acid, Placebo (for Sarilumab)
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SarilumabDrug
Also called SAR153191/REGN88
Pharmaceutical form: Prefilled syringes; Route of administration: Subcutaneous
PrednisoneDrug
Pharmaceutical form: Tablet or Capsule; Route of administration: Oral
MethotrexateDrug
Pharmaceutical form: Tablet or Capsule or Suspension; Route of administration: Orally or intravenously or intramuscular
Folic/folinic acidDrug
Pharmaceutical form: Tablet or Capsule; Route of administration: Oral
Placebo (for Sarilumab)Other
Pharmaceutical form: Prefilled syringes; Route of administration: Subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo (for Sarilumab) subcutaneous (SC) injection every 2 weeks (q2w) for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with Methotrexate (MTX) 10 to 25 mg/week and folic acid per local prescribing practice. Responders continued with the same treatment regimen up to Week 50 during extension treatment period (Part B) and non-responders were proposed to be treated with open-label Sarilumab 200 mg q2w in open-label treatment period (Part-C). Receives: Drug: Sarilumab; Drug: Prednisone; Drug: Methotrexate; Drug: Folic/folinic acid; Other: Placebo (for Sarilumab) |
| Sarilumab 200 mg q2w | Experimental | Sarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice. Responders continued with the same treatment regimen up to Week 50 during extension treatment period (Part B) and non-responders were proposed to be treated with open-label Sarilumab 200 mg q2w in open-label treatment period (Part-C). Receives: Drug: Sarilumab; Drug: Prednisone; Drug: Methotrexate; Drug: Folic/folinic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With at Least 2-step Reduction in Vitreous Haze (VH) or Prednisone Dose <10 mg/Day at Week 16
At least 2-step reduction in VH per central review from baseline was evaluated on Miami 9-step scale. VH is the obscuration of fundus by vitreous cells and protein exudation. Each of the 9-step scale (from grade 0 [low opacity] to 8 [more opacity]) images (in increasing order of opacity) are equivalent to approximately 0.3 log units of degradation in visual acuity based on the Bangerter calibration. Participants with prednisone dose <10 mg/day (or equivalent oral corticosteroid) were also evaluated.
Measured: Week 16
Secondary outcomes (9)
Change From Baseline in VH Scale at Week 16
Change from baseline in VH scale was evaluated on Miami 9-step scale. VH is the obscuration of fundus by vitreous cells and protein exudation. Each of the 9-step scale (from grade 0 [low opacity] to 8 [more opacity]) images (in increasing order of opacity) were equivalent to approximately 0.3 log units of degradation in visual acuity based on the Bangerter calibration. Least squares (LS) mean was calculated using mixed model for repeated measurements (MMRM) model with treatment groups, visits and visit-by-treatment groups interaction as fixed categorical effects as well as fixed continuous covariate of baseline adjudicated VH.
Measured: Baseline to Week 16
Percentage of Participants With Anterior Chamber (AC) Cell Score = 0 or At Least 2-step Reduction in Score at Week 16
Participants with AC cell score = 0 or with ≥2 step reduction from baseline at Week 16 were evaluated. Slit lamp examinations were conducted at each visit to assess AC cell count. The number of AC cells observed within a 1 mm × 1 mm slit beam was used to determine the grade according to the Standardization of Uveitis Nomenclature (SUN) criteria: grade 0 = no cells; grade +0.5 = 1 - 5 cells; grade +1 = 6 - 25 cells; grade +2= 26 - 50 cells; grade +3 = too many to count.
Measured: Week 16
Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Week 16
BCVA score is based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters, and then at 1 meter. The range of ETDRS is 0 to 100 letters. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. LS mean was calculated using MMRM model with treatment groups, randomization strata of VH level (<4, >=4), visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline BCVA.
Measured: Baseline to Week 16
Change From Baseline in Central Retinal Thickness (CRT) At Week 16
CRT was measured by spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. All images were transmitted to the central reading center. SD-OCT was performed in the study eye after pupil dilation. LS mean was calculated using MMRM model with treatment groups, randomization strata of VH level (<4, >=4), visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline CRT.
Measured: Baseline to Week 16
Percent Change From Baseline in CRT at Week 16
CRT was measured by SD-OCT, a non-invasive diagnostic system providing high-resolution imaging sections of the retina. All images were transmitted to the central reading center. SD-OCT was performed in the study eye after pupil dilation. LS mean was calculated using MMRM model with treatment groups, randomization strata of VH level (<4, >=4), visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline CRT.
Measured: Baseline to Week 16
Percentage of Participants With CRT Thickness <300 Microns at Week 16
Measured: Week 16
Percentage of Participants Without Retinal Vessel Leakage on Fluorescein Angiography (FA) at Week 16
Measured: Week 16
Percentage of Participants With Prednisone Dose of ≤5 mg/Day (or Equivalent Oral Corticosteroid) at Week 16
Participants with prednisone dose ≤5 mg/day (or equivalent oral corticosteroid) at Week 16 were evaluated.
Measured: Week 16
Pharmacokinetics (PK) Assessment: Serum Functional Sarilumab Concentration
Serum functional (unbound) sarilumab concentrations were determined using an enzyme-linked immunosorbent assay (ELISA) method with a lower limit of quantification (LLOQ) of 294 ng/mL. Concentrations below LLOQ were set to zero for samples at predose. Post-treatment concentrations below LLOQ were replaced by LLOQ/2. The samples were considered non-eligible for the analysis if the previous dosing time was <11 days or >17 days before the sampling time for every other week regimens.
Measured: Predose on Day 1 (Baseline), Week 2, 4, 8, 12, 16, 24, 36, 52, and end of study (EOS) (Week 56)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2013 (estimated)
- Study startOct 2013
- Primary completionJul 2015
- Study completionApr 2016
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.
- Other trials for UveitisStudies of the same condition, open and under way.
- More trials run by SanofiThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01900431
- Sponsor's protocol ID
- ACT13480
- Other IDs
- 2012-004845-34, U1111-1130-6500
- Acronym
- SARILNIUSATURN
- Status last verified
- May 2017
- First submitted
- 11 Jul 2013
- Last updated
- 20 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Masked and Placebo-Controlled Study to Evaluate the Efficacy and Safety of Sarilumab Administered Subcutaneously Every 2 Weeks in Patients With Non-Infectious, Intermediate, Posterior or Pan-Uveitis (NIU)
- ClinicalTrials.gov ID
- NCT01900431
- Acronym / sponsor ID
- SARILNIUSATURN / ACT13480
- Conditions
- Uveitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 16 Jul 2013 (estimated)
- Results
- Posted 20 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
To evaluate the efficacy of sarilumab at Week 16 in participants with non-infectious uveitis (NIU).
Secondary Objectives:
To evaluate the change in best corrected visual acuity (BCVA). To evaluate the safety of subcutaneous sarilumab in participants with NIU. To evaluate the change in macular edema. To evaluate the change in other signs of ocular inflammation. To evaluate the effect on retinal vessel leakage. To evaluate the effect of sarilumab on reducing concomitant immunosuppressant therapy.
To evaluate the change in ocular inflammation in the anterior chamber. To evaluate the pharmacokinetics of sarilumab in NIU participants. To evaluate the immunogenicity with anti-drug antibodies (ADA).
Detailed description
The total duration per participant was up to 58 weeks, which included a 2 week screening period, 16 weeks principal treatment period (Part A), 34 weeks extension treatment period (Part B) or open label treatment period (Part C), and 6 weeks after last treatment administration.
Participants with decrease in vitreous haze (VH) ≥2; or corticosteroids dose <10 mg/day at Week 16 were considered as responders. Participants who did not complete the principal treatment period (Part A) due to lack of efficacy; or no decrease in VH ≥2 and corticosteroids dose ≥10 mg/day at Week 16; or no decrease in VH ≥2 and corticosteroids dose missing at Week 16; or non-responder according to medical review, were considered as non-responders.
Responder participants, observed at Week 16 (at the end of Part A), were invited to continue in the extension treatment period (Part B).
Non-responder participants, observed within the first 16 weeks, were offered to be treated by open-label sarilumab (Part C).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Sarilumab, Drug: Prednisone, Drug: Methotrexate, Drug: Folic/folinic acid, Other: Placebo (for Sarilumab)Placebo (for Sarilumab) subcutaneous (SC) injection every 2 weeks (q2w) for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with Methotrexate (MTX) 10 to 25 mg/week and folic acid per local prescribing practice. Responders continued with the same treatment regimen up to Week 50 during extension treatment period (Part B) and non-responders were proposed to be treated with open-label Sarilumab 200 mg q2w in open-label treatment period (Part-C). |
| Sarilumab 200 mg q2w | Experimental | Drug: Sarilumab, Drug: Prednisone, Drug: Methotrexate, Drug: Folic/folinic acidSarilumab 200 mg SC injection q2w for 16 weeks during principal treatment period (Part A) with background therapy of Prednisone (or equivalent oral corticosteroid) ≥15 mg/day and <80 mg/day as single therapy or in combination with MTX 10 to 25 mg/week and folic acid per local prescribing practice. Responders continued with the same treatment regimen up to Week 50 during extension treatment period (Part B) and non-responders were proposed to be treated with open-label Sarilumab 200 mg q2w in open-label treatment period (Part-C). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ≥18 years of age.
- Non-infectious intermediate, posterior, or pan-uveitis in the study eye.
- Active disease at screening or evidence of activity within the 3 months prior to screening visit. Following the approval of amendment-2, only participants with "active disease" as defined above were enrolled in the study.
- Starting oral prednisone dose must be greater than or equal to 15 mg/day and less than 80 mg/day.
- At screening, participants must be receiving oral prednisone (≥15 mg and <80 mg/day [or equivalent oral corticosteroid]) as single immunosuppressive therapy or in combination with MTX (≤25 mg/week) orally or intravenously or intramuscular or subcutaneous). -
Key exclusion criteria (5 listed)
- Participants with best-corrected visual acuity (BCVA) worse than 20 early treatment diabetic retinopathy study (ETDRS) letters in at least one eye.
- Participants with confirmed or suspected uveitis of infectious etiology or uveitis of traumatic etiology.
- Participants with primary diagnosis of anterior uveitis.
- Prior treatment with anti-interleukin-6 (IL-6) or interleukin-6 receptor complex (IL-6R) antagonist therapies, including tocilizumab and sarilumab.
- The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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 |
|---|---|---|
| SarilumabAlso: SAR153191/REGN88Pharmaceutical form: Prefilled syringes; Route of administration: Subcutaneous | Drug | Placebo, Sarilumab 200 mg q2w |
| PrednisonePharmaceutical form: Tablet or Capsule; Route of administration: Oral | Drug | Placebo, Sarilumab 200 mg q2w |
| MethotrexatePharmaceutical form: Tablet or Capsule or Suspension; Route of administration: Orally or intravenously or intramuscular | Drug | Placebo, Sarilumab 200 mg q2w |
| Folic/folinic acidPharmaceutical form: Tablet or Capsule; Route of administration: Oral | Drug | Placebo, Sarilumab 200 mg q2w |
| Placebo (for Sarilumab)Pharmaceutical form: Prefilled syringes; Route of administration: Subcutaneous | Other | Placebo |
Primary outcome
Percentage of Participants With at Least 2-step Reduction in Vitreous Haze (VH) or Prednisone Dose <10 mg/Day at Week 16
Time frame: Week 16
At least 2-step reduction in VH per central review from baseline was evaluated on Miami 9-step scale. VH is the obscuration of fundus by vitreous cells and protein exudation. Each of the 9-step scale (from grade 0 [low opacity] to 8 [more opacity]) images (in increasing order of opacity) are equivalent to approximately 0.3 log units of degradation in visual acuity based on the Bangerter calibration. Participants with prednisone dose <10 mg/day (or equivalent oral corticosteroid) were also evaluated.
9 secondary outcomes
Change From Baseline in VH Scale at Week 16
Time frame: Baseline to Week 16
Percentage of Participants With Anterior Chamber (AC) Cell Score = 0 or At Least 2-step Reduction in Score at Week 16
Time frame: Week 16
Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Week 16
Time frame: Baseline to Week 16
Change From Baseline in Central Retinal Thickness (CRT) At Week 16
Time frame: Baseline to Week 16
Percent Change From Baseline in CRT at Week 16
Time frame: Baseline to Week 16
Percentage of Participants With CRT Thickness <300 Microns at Week 16
Time frame: Week 16
Percentage of Participants Without Retinal Vessel Leakage on Fluorescein Angiography (FA) at Week 16
Time frame: Week 16
Percentage of Participants With Prednisone Dose of ≤5 mg/Day (or Equivalent Oral Corticosteroid) at Week 16
Time frame: Week 16
Pharmacokinetics (PK) Assessment: Serum Functional Sarilumab Concentration
Time frame: Predose on Day 1 (Baseline), Week 2, 4, 8, 12, 16, 24, 36, 52, and end of study (EOS) (Week 56)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Clinical Sciences & Operations study director
Sanofi
20 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sarilumab, Prednisone and Methotrexate in people with Uveitis, run by Sanofi at 20 sites in 6 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 10 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 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Turkey (Türkiye), United States, Italy, Czechia, France and 1 more country. 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 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?
Yes. Results are posted in the registry (first posted 20 Jun 2017). 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 Participants With at Least 2-step Reduction in Vitreous Haze (VH) or Prednisone Dose <10 mg/Day at Week 16 (time frame: Week 16). 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 20 Jun 2017.