A Phase III extension study to evaluate the long-term safety of DE-109 in subjects with non-infectious uveitis of the posterior segment of the eye who have participated in a previous SAKURA study.

Phase 1

Conditions: non -infectious Uveitis of the Posterior Segment of the Eye
MedDRA version: 17.1Level: LLTClassification code 10036370Term: Posterior uveitisSystem Organ Class: 100000004862
Therapeutic area: Body processes [G] - Ocular Physiological Phenomena [G14]

Registration Number: EUCTR2014-004042-96-AT

Lead Sponsor: Santen Incorporated

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

At Day 1, a subject from the SAKURA program must meet all of the following inclusion criteria:
1. Have a subject number from participation in the SAKURA program
2. Exited the SAKURA program under Amendment 05
3. Have received at least two injections of DE-109 in the first five months of the SAKURA program
4. Received clinical benefit from treatment with DE-109 as determined by the Investigator
5. Female participants of childbearing potential must not be pregnant or breast-feeding, have a negative pregnancy test at Day 1 and must be willing to undergo pregnancy tests throughout the study
6. Both female participants of childbearing potential and male participants able to father children must have (or have a partner who has) had a hysterectomy or vasectomy, must abstain from
intercourse or must agree to practice acceptable methods of contraception throughout the course of the study
7. Ability to give informed consent and attend all study visits
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 170
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

A subject from the SAKURA program with any of the following conditions is not eligible to participate in the study:

Ocular:
1. Active infectious uveitis. However, if the uveitis is the consequence of a previous infectious disease, such as tuberculosis, the previous infectious disease must be confirmed as no longer
active.
2. Any implantable corticosteroid-eluting device (e.g. Ozurdex, I-vation, Iluvien, fluocinolone acetonide [FA] intravitreal implant) in the study eye:
a. If the Investigator confirms the device has no demonstrable efficacy as indicated in the package insert, the subject will be eligible
b. If a Medidur implant, Iluvien or Retisert has been implanted no less than 3 years and 90 days prior to Day 1, the subject will be eligible
c. If a Ozurdex implant has been implanted no less than 180 days prior to Day 1, the subject will be eligible
3. Clinically suspected or confirmed central nervous system or ocular lymphoma
4. Progressive glaucoma which is unresponsive to treatment.
5. Intraocular pressure of > 21 mmHg while on medical therapy, or chronic hypotony (< 6 mmHg)
6. Any significant ocular disease that could compromise vision in the study eye. These include, but are not limited to:
a. Diabetic retinopathy: proliferative diabetic retinopathy (PDR) or non-proliferative diabetic retinopathy (NPDR) that compromises vision. Subjects with NPDR or PDR that does not compromise vision are not excluded from the study;
b. Wet age-related macular degeneration;
c. Myopic degeneration with active subfoveal choroidal neovascularization
7. Any of the following treatments to the study eye:
a. Intravitreal injections in the past 14 days
b. Intravitreal injections of DE-109 in the past 60 days
8. Ocular surgery within the past 30 days
9. Ocular or periocular infection in either eye
10. History of or active herpetic infection in the study eye or adnexa
11. Presence of known active, inactive toxoplasmosis or toxoplasmosis scar in either eye
12. Presence of any form of ocular malignancy in the either eye including choroidal melanoma
13. History of vitrectomy in the study eye

Non-Ocular:
14. Allergy or hypersensitivity to study drug product or other study related procedures/medications
15. Participation in other investigational drug (SAKURA is an exception) or device clinical trials within 30 days prior to Day 1, or planning to participate in other investigational drug or device
clinical trials for the entire duration of the study. This includes both ocular and non-ocular clinical trials.
16. Any recent systemic infection within 30 days of Day 1
17. Known to be immunocompromised
18. History of cytomegalovirus infection or clinical evidence of active cytomegalovirus infection at Day 1
19. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease condition that contraindicates the use of an investigational drug, might affect the interpretation of the results of the study, or renders the subject at high risk for treatment complications
20. Malignancy in remission for less than 5 years prior to study participation (except basal cell or squamous cell skin cancer, or treated melanoma of the skin less than 24 months since last
treatment)
21. Females who are pregnant or lactating and females of child-bearing potential who are not using adequate contraceptive precautions (i.e., intrauterine device, oral contraceptives, bar

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: 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.;Primary end point(s): Collection of long term safety data on DE-109 (440 µg) dose<br><br>;Timepoint(s) of evaluation of this end point: 12 months or commercial availability of DE-109, whichever comes first.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): none;Timepoint(s) of evaluation of this end point: none

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