Phase 3
Completed N=60
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
Non-Infectious Uveitis of the Posterior Segment of the Eye
Source: ClinicalTrials.gov NCT02251938 ↗
Enrolled (actual)
60
Serious AEs
13.3%
Results posted
Feb 2020
Primary outcomePrimary: Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 in the Study Eye — 2.1 ETDRS Letters
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 in the Study Eye |
2.1 | — |
| PRIMARY Mean Change From Baseline in Intraocular Pressure at Month 12 in the Study Eye |
0.3 | — |
| PRIMARY Number of Subjects With a Shift in Choroid Status at Month 12 in the Study Eye. |
36; 0; 4; 3 | — |
| PRIMARY Changes From Baseline in Vitreous Haze (VH) Scores at Month 12 |
-0.09 | — |
| PRIMARY Number of Subjects Who Receive Rescue Therapy. |
9 | — |
| PRIMARY Number of Subjects With a Shift in Macula Status at Month 12 in the Study Eye. |
20; 2; 6; 15 | — |
| PRIMARY Number of Subjects With a Shift in Optic Nerve Status at Month 12 in the Study Eye. |
39; 2; 0; 2 | — |
| PRIMARY Number of Subjects With a Shift in Retina Status at Month 12 in the Study Eye. |
34; 2; 1; 6 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02251938). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.