Non-Infectious Uveitis of the Posterior Segment of the EyePhase 3SPRINGNCT02251938
A Phase IIIb, Multinational, Multicenter, Open-Label Extension Study Assessing the Long-Term Safety of PRN Intravitreal Injections of DE-109 in Subjects With Non-Infectious Uveitis of the Posterior Segment of the Eye Who Have Participated in the SAKURA Development Program
A Phase 3 study testing DE-109 440 μg in people with Non-Infectious Uveitis of the Posterior Segment of the Eye, run by Santen Inc. at 25 sites in 6 countries.
Trial summary
The objective of this extension study is to evaluate the long-term safety of treatment with DE-109 (440 μg) in subjects with non-infectious uveitis of the posterior segment of the eye who have participated in the SAKURA development program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Infectious Uveitis of the Posterior Segment of the Eye
- What is being tested?
- DE-109 440 μg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 25 sitesin 6 countries
- Study dates
- 29 Sep 2014to 27 Nov 2017
- Phase
- Phase 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
- Participated in the SAKURA study
- Received clinical benefit from treatment in the SAKURA study
- Ability to sign informed consent and attend all study visits
Who cannot join
- Uveitis of infectious etiology
- Implanted device
- Suspected or confirmed central nervous system or ocular lymphoma
- Uncontrolled glaucoma
- Significant ocular disease
- Intravitreal injections in the past 60 days
Show all 22Show fewer
- Intraocular surgery or treatment
- Ocular or periocular infection
- History of herpetic infection
- Toxoplasmosis or toxoplasmosis scar
- Ocular malignancy
- Vitrectomy
- Allergy or hypersensitivity to study drug
- Participation in other uveitis device clinical trials within 30 days
- Any recent systemic condition/infection
- Immunosuppressive therapy or immunocomprimised
- Cytomegalovirus infection
- Malignancy in remission
- Females who are pregnant or lactating and who are not using adequate contraceptive
- Medical marijuana or illegal drug use
- Systemic saroidosis
- Therapeutic radiation to the head or neck
Trial locations and contacts
25 sites in 6 countries.
25 sites in 6 countries
United States13 sites
Study site
Austin, Texas
Study site
Golden, Colorado
Study site
Jackson, Michigan
Study site
New Brunswick, New Jersey
Study site
New York, New York
Study site
Oak Park, Illinois, 60304
Study site
Orchard Park, New York
Study site
Palisades Park, New Jersey
Study site
Phoenix, Arizona
Study site
Sacramento, California
Study site
Salt Lake City, Utah
Study site
St Louis, Missouri
Study site
Tampa, Florida
India7 sites
Study site
Aurobindo Marg, New Dehli
Study site
Bhubaneswar, Odisha
Study site
Chennai, Tamil Nadu
Study site
Daryāganj, New Dehli
Study site
Hyderabad, Andhra Pradesh
Study site
Madurai, Tamil Nadu
Study site
Noida, Uttar Pradesh
About this study
The objective of this extension study is to evaluate the long-term safety of treatment with DE-109 (440 μg) in subjects with non-infectious uveitis of the posterior segment of the eye who have participated in the SAKURA development program.
Read the detailed description
This is a multicenter, open-label, extension study of intravitreal injections of the 440 μg dose of DE-109 in subjects with non-infectious uveitis of the posterior segment who received any dose of DE-109 and exited the SAKURA program under Santen Protocol 32-007, Amendment 05.
Subjects who were randomized and received at least two injections of DE-109 during the first five months of the SAKURA program and obtained clinical benefit from the study medication, as determined by the Investigator, may be considered for entry in this 12-month extension study. The minimum time lag from last injection in the SAKURA program to entry into the current protocol is 60 days.
- Being tested
- DE-109 440 μg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DE-109 440 μgDrug
Also called Sirolimus
Medium Dose
| Study group | Role | What they receive |
|---|---|---|
| DE-109 Sirolimus | Experimental | DE-109 440 μg Receives: Drug: DE-109 440 μg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 in the Study Eye
Best Corrected Visual Acuity (BCVA) measures the acuteness or clearness of best-corrected vision in ETDRS (Early Treatment of Diabetic Retinopathy Study) letters. An increase in BCVA indicates improvement in the best-corrected vision. A BCVA score of 85 ETDRS letters is equivalent to 20/20 vision, which is considered normal vision.
Measured: Day 1 (Baseline) and Month 12 or early termination visit
Mean Change From Baseline in Intraocular Pressure at Month 12 in the Study Eye
Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg) with one decimal point.
Measured: Day 1 (Baseline) and Month 12 or early termination visit
Number of Subjects With a Shift in Choroid Status at Month 12 in the Study Eye.
Ophthalmoscopy findings were reported as normal or abnormal.
Measured: Day 1 (Baseline) and Month 12 or early termination visit
Changes From Baseline in Vitreous Haze (VH) Scores at Month 12
Vitreous Haze (VH) scores were measured using the modified Standardized Uveitis Nomenclature Photographic Scale (SUN) :
0 No inflammation
0.5+ Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex)
- Mild blurring of the retinal vessels and optic nerve 1.5+ Optic nerve head and posterior retina view obstruction greater than 1+ but less than 2+
- Moderate blurring of the optic nerve head
- Marked blurring of the optic nerve head
- Optic Nerve head not visible
Measured: Day 1 (Baseline) and Month 12 or early termination visit
Number of Subjects Who Receive Rescue Therapy.
Rescue therapy was defined as any treatment that would have a therapeutic effect on the uveitis in the posterior segment (e.g., systemic treatment with an immunosuppressant agent, or a corticosteroid injection in the study eye) other than intravitreal DE-109 determined by the Investigator.
Measured: By Month12
Number of Subjects With a Shift in Macula Status at Month 12 in the Study Eye.
Ophthalmoscopy findings were reported as normal or abnormal.
Measured: Day 1 (Baseline) and Month 12 or early termination visit
Number of Subjects With a Shift in Optic Nerve Status at Month 12 in the Study Eye.
Ophthalmoscopy findings were reported as normal or abnormal.
Measured: Day 1 (Baseline) and Month 12 or early termination visit
Number of Subjects With a Shift in Retina Status at Month 12 in the Study Eye.
Ophthalmoscopy findings were reported as normal or abnormal.
Measured: Day 1 (Baseline) and Month 12 or early termination visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2014 (estimated)
- Study start29 Sep 2014
- Primary completion1 Nov 2017
- Study completion27 Nov 2017
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 Non-Infectious Uveitis of the Posterior Segment of the EyeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lanita Scott, MD, Study director, Santen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02251938
- Sponsor's protocol ID
- 32-009
- Acronym
- SPRING
- Status last verified
- Jan 2020
- First submitted
- 19 Sep 2014
- Last updated
- 12 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIIb, Multinational, Multicenter, Open-Label Extension Study Assessing the Long-Term Safety of PRN Intravitreal Injections of DE-109 in Subjects With Non-Infectious Uveitis of the Posterior Segment of the Eye Who Have Participated in the SAKURA Development Program
- ClinicalTrials.gov ID
- NCT02251938
- Acronym / sponsor ID
- SPRING / 32-009
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Santen Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Sep 2014 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 27 Nov 2017 (actual)
- First posted
- 29 Sep 2014 (estimated)
- Results
- Posted 12 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this extension study is to evaluate the long-term safety of treatment with DE-109 (440 μg) in subjects with non-infectious uveitis of the posterior segment of the eye who have participated in the SAKURA development program.
Detailed description
This is a multicenter, open-label, extension study of intravitreal injections of the 440 μg dose of DE-109 in subjects with non-infectious uveitis of the posterior segment who received any dose of DE-109 and exited the SAKURA program under Santen Protocol 32-007, Amendment 05.
Subjects who were randomized and received at least two injections of DE-109 during the first five months of the SAKURA program and obtained clinical benefit from the study medication, as determined by the Investigator, may be considered for entry in this 12-month extension study. The minimum time lag from last injection in the SAKURA program to entry into the current protocol is 60 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DE-109 Sirolimus | Experimental | Drug: DE-109 440 μgDE-109 440 μg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participated in the SAKURA study
- Received clinical benefit from treatment in the SAKURA study
- Ability to sign informed consent and attend all study visits
Key exclusion criteria (22 listed)
- Uveitis of infectious etiology
- Implanted device
- Suspected or confirmed central nervous system or ocular lymphoma
- Uncontrolled glaucoma
- Significant ocular disease
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 |
|---|---|---|
| DE-109 440 μgAlso: SirolimusMedium Dose | Drug | DE-109 Sirolimus |
Primary outcome
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 in the Study Eye
Time frame: Day 1 (Baseline) and Month 12 or early termination visit
Best Corrected Visual Acuity (BCVA) measures the acuteness or clearness of best-corrected vision in ETDRS (Early Treatment of Diabetic Retinopathy Study) letters. An increase in BCVA indicates improvement in the best-corrected vision. A BCVA score of 85 ETDRS letters is equivalent to 20/20 vision, which is considered normal vision.
Mean Change From Baseline in Intraocular Pressure at Month 12 in the Study Eye
Time frame: Day 1 (Baseline) and Month 12 or early termination visit
Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg) with one decimal point.
Number of Subjects With a Shift in Choroid Status at Month 12 in the Study Eye.
Time frame: Day 1 (Baseline) and Month 12 or early termination visit
Ophthalmoscopy findings were reported as normal or abnormal.
Changes From Baseline in Vitreous Haze (VH) Scores at Month 12
Time frame: Day 1 (Baseline) and Month 12 or early termination visit
Vitreous Haze (VH) scores were measured using the modified Standardized Uveitis Nomenclature Photographic Scale (SUN) : 0 No inflammation 0.5+ Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex) 1. Mild blurring of the retinal vessels and optic nerve 1.5+ Optic nerve head and posterior retina view obstruction greater than 1+ but less than 2+ 2. Moderate blurring of the optic nerve head 3. Marked blurring of the optic nerve head 4. Optic Nerve head not visible
Number of Subjects Who Receive Rescue Therapy.
Time frame: By Month12
Rescue therapy was defined as any treatment that would have a therapeutic effect on the uveitis in the posterior segment (e.g., systemic treatment with an immunosuppressant agent, or a corticosteroid injection in the study eye) other than intravitreal DE-109 determined by the Investigator.
Number of Subjects With a Shift in Macula Status at Month 12 in the Study Eye.
Time frame: Day 1 (Baseline) and Month 12 or early termination visit
Ophthalmoscopy findings were reported as normal or abnormal.
Number of Subjects With a Shift in Optic Nerve Status at Month 12 in the Study Eye.
Time frame: Day 1 (Baseline) and Month 12 or early termination visit
Ophthalmoscopy findings were reported as normal or abnormal.
Number of Subjects With a Shift in Retina Status at Month 12 in the Study Eye.
Time frame: Day 1 (Baseline) and Month 12 or early termination visit
Ophthalmoscopy findings were reported as normal or abnormal.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- 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.
Lanita Scott, MD study director
Santen Inc.
25 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DE-109 440 μg in people with Non-Infectious Uveitis of the Posterior Segment of the Eye, run by Santen Inc. at 25 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 3 inclusion and 22 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 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, India, Turkey (Türkiye), Austria, 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. 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 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 12 Feb 2020). 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?
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 in the Study Eye (time frame: Day 1 (Baseline) and Month 12 or early termination visit). The study lists 8 primary outcomes in all. 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 12 Feb 2020.