Phase 3 N=60 Treatment

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

Bottom Line

View on ClinicalTrials.gov: NCT02251938 ↗

Enrolled (actual)

Serious AEs

13.3%

Results posted

Feb 2020

Primary outcome: Primary: Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 in the Study Eye — 2.1 ETDRS Letters

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: DE-109 440 μg (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Santen Inc.
Primary completion: Nov 2017

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	—

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.

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

View full record on ClinicalTrials.gov →

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.