Non-Infectious Uveitis of the Posterior Segment of the Eye Clinical Trial
— SPRINGOfficial 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
| Verified date | January 2020 |
| Source | Santen Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | November 27, 2017 |
| Est. primary completion date | November 1, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. Participated in the SAKURA study 2. Received clinical benefit from treatment in the SAKURA study 3. Ability to sign informed consent and attend all study visits Exclusion Criteria: 1. Uveitis of infectious etiology 2. Implanted device 3. Suspected or confirmed central nervous system or ocular lymphoma 4. Uncontrolled glaucoma 5. Significant ocular disease 6. Intravitreal injections in the past 60 days 7. Intraocular surgery or treatment 8. Ocular or periocular infection 9. History of herpetic infection 10. Toxoplasmosis or toxoplasmosis scar 11. Ocular malignancy 12. Vitrectomy 13. Allergy or hypersensitivity to study drug 14. Participation in other uveitis device clinical trials within 30 days 15. Any recent systemic condition/infection 16. Immunosuppressive therapy or immunocomprimised 17. Cytomegalovirus infection 18. Malignancy in remission 19. Females who are pregnant or lactating and who are not using adequate contraceptive 20. Medical marijuana or illegal drug use 21. Systemic saroidosis 22. Therapeutic radiation to the head or neck |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Santen Inc. |
United States, Austria, France, India, Italy, Turkey,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Day 1 (Baseline) and Month 12 or early termination visit | |
| Primary | 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. | Day 1 (Baseline) and Month 12 or early termination visit | |
| Primary | Number of Subjects With a Shift in Choroid Status at Month 12 in the Study Eye. | Ophthalmoscopy findings were reported as normal or abnormal. | Day 1 (Baseline) and Month 12 or early termination visit | |
| Primary | 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 |
Day 1 (Baseline) and Month 12 or early termination visit | |
| Primary | 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. | By Month12 | |
| Primary | Number of Subjects With a Shift in Macula Status at Month 12 in the Study Eye. | Ophthalmoscopy findings were reported as normal or abnormal. | Day 1 (Baseline) and Month 12 or early termination visit | |
| Primary | 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. | Day 1 (Baseline) and Month 12 or early termination visit | |
| Primary | Number of Subjects With a Shift in Retina Status at Month 12 in the Study Eye. | Ophthalmoscopy findings were reported as normal or abnormal. | Day 1 (Baseline) and Month 12 or early termination visit |