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

Phase 3
Conditions
Health Condition 1: H208- Other iridocyclitisHealth Condition 2: H358- Other specified retinal disorders
Registration Number
CTRI/2015/07/006025
Lead Sponsor
SANTEN INCORPORATED
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Closed to Recruitment of Participants
Sex
Not specified
Target Recruitment
0
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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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