Assessment of long term safety of DE-109 in patients with non-infectious uveitis of the posterior segment of the eye

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 - SPRING STUDY

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/07/006025

Enrollment

200

Registered

2015-07-17

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H208- Other iridocyclitis Health Condition 2: H358- Other specified retinal disorders

Interventions

Intervention1: DE-109 (Sirolimus): 440 Âµg of Intravitreal Injection in the Study Eye. Subjects will be treated at the discretion of the investigator, but no more frequently than every 60 days over a

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The long-term safety of DE-109 440 Î¼g will be assessed based on adverse events, visual acuity, intraocular pressure, indirect ophthalmoscopy variables, vitreous haze and the use of rescue therapy.Timepoint: 12 months	—

Secondary

Measure	Time frame
Not ApplicableTimepoint: Not Applicable	—

Countries

Austria, France, Germany, India, Italy, Poland, Turkey, United States of America

Contacts

Public ContactDr Saurendra Das

Excel Life Sciences Pvt Ltd

sauren@excellifesciences.com0120-4022600

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026