Uveitis; Posterior, Disorder Clinical Trial
— SAKURAOfficial title:
A Phase III, Multinational, Multicenter, Randomized, Double-Masked, Study for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye
| NCT number | NCT01358266 |
| Other study ID # | 32-007 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | |
| Last updated | |
| Start date | May 2011 |
| Est. completion date | December 2016 |
| Verified date | June 2019 |
| Source | Santen Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to evaluate the safety and efficacy of intravitreal injections of DE-109 ophthalmic solution.
| Status | Completed |
| Enrollment | 592 |
| Est. completion date | December 2016 |
| Est. primary completion date | September 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Confirmed diagnosis of active uveitis - 18 years of age or older - Sign informed consent - Meet best corrected ETDRS visual acuity Exclusion Criteria: - Uveitis of infectious etiology - Suspected/confirmed central nervous system or ocular lymphoma - Primary diagnosis of anterior uveitis - Uncontrolled glaucoma - Use of topical oculary medication - Implanted device - Significant ocular disease - Lens/media opacities or obscured ocular media - Intraocular surgery or treatments - Capsulotomy - Ocular or periocular infection - Pupillary dilation - History of herpetic infection - Toxoplasmosis or toxoplasmosis scar - Ocular malignancy - Allergy or hypersensitivity to study drug - Participation in other uveitis trial within 30 days - Monoclonal antibody treatment or biologic therapy - Any systemic condition/infection - Immunosuppressive therapy or immunocompromised - Malignancy remission - Females who are pregnant or lactating and females not using adequate contraceptives |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Santen Inc. |
United States, Argentina, Austria, Brazil, Chile, Colombia, France, Germany, India, Israel, Italy, Japan, Peru, Poland, Spain, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | VH 0 Response at Month 6: Having a VH Score of 0 at Month 6 (Modified SUN Scale) | At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Description VH score 0 = No inflammation |
Day1/Baseline and Day180/Month 6 | |
| Other | VH 0 or 2-unit Response at Month 6: Having a VH Score of 0 or a Decrease (Improvement) of at Least 2 Units From Baseline in VH Score at Month 6 (Modified SUN Scale) | At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Step Description 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 |
Day1/Baseline and Day180/Month 6 | |
| Other | VH 0 or 0.5+ Response at Month 6: Having a VH Score of 0 or 0.5+ at Month 6 (Modified SUNscale) | At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Step Description 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 |
Day1/Baseline and Day180/Month 6 | |
| Primary | The Primary Endpoint, VH 0 Response, Was Defined as Having a VH Score of 0 at Month 5 | At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Description VH score 0 = No inflammation |
Day1 (Baseline) and Month 5 (Day150) | |
| Secondary | VH 0 or 2-unit Response: Having a Reduction (Improvement) of at Least 2 Units From Baseline in VH Score or a VH Score of 0 at Month 5 (Modified SUN Scale) | At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Step Description 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 |
Day1/Baseline and Day150/Month 5 | |
| Secondary | VH 0 or 0.5+ Response: Having a VH Score of 0 or 0.5+ at Month 5 (Modified SUN Scale) | At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Description VH score 0.5+=Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex) | Day1/Baseline and Day150/Month 5 |