DE-109 440 μg
DrugMedium Dose
Other names: Sirolimus
Completed
NCT Number: NCT02251938
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
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.
Completed
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Notify MeKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Graz, Austria
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About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Participated in the SAKURA study
- Received clinical benefit from treatment in the SAKURA study
- Ability to sign informed consent and attend all study visits
Exclusion criteria
- 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
- 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
Treatment and study plan
Primary outcomes
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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.
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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.
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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)
- 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
-
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.
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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.
Sponsors and collaborators
Lead sponsor
Santen Inc.
Industry
Registry information
Acronym: SPRING
Important dates
- Study start
- 2014
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Sep 29, 2014
- Registry last updated
- Feb 12, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.