A PHASE III, MULTINATIONAL, MULTICENTER, RANDOMIZED, DOUBLE-MASKED, STUDY ASSESSING THE SAFETY AND EFFICACY OF INTRAVITREAL INJECTIONS OF DE-109 (THREE DOSES) FOR THE TREATMENT OF ACTIVE, NON-INFECTIOUS UVEITIS OF THE POSTERIOR SEGMENT OF THE EYE.

Not Applicable

• Registration Number: PER-004-12
• Lead Sponsor: SANTEN INCORPORATED,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-04
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 0

Inclusion Criteria

1. ABILITY TO GIVE INFORMED CONSENT AND ATTEND ALL STUDY VISITS
2. MALES OR FEMALES GREATER THAN OR EQUAL TO 18 YEARS OF AGE.
3. HAVE DIAGNOSIS OF ACTIVE UVEITIS DETERMINED BY THE INVESTIGATOR TO BE NON-INFECTIOUS BASED ON THE SUBJECT´S MEDICAL HISTORY, HISTORY OF PRESENT ILLNESS, OCULAR EXAMINATION, REVIEW OF SYSTEMS, PHYSICAL EXAMNATION, AND ANY RELEVANT, PERTINENT LABORATORY EVALUATIONS. IF AN ANTERIOR COMPONENT IS PRESENT, IT MUST BE LESS THAN THE POSTERIOR COMPONENT
4. HAVE ACTIVE UVEITIS DEFINED AS HAVING >1+ (EXCLUDING 1+) VITREOUS HAZE SCORE (SUN SCALE)
5. BEST CORRECTED ETDRS VISUAL ACUITY LETTER SCORE OF 19 LETTERS OR MORE (20/400 SNELLEN EQUIVALENT) OR BETTER IN STUDY EYE.

Exclusion Criteria

SUBJECTS WITH ANY OF THE FOLLOWING CONDITIONS ARE NOT ELEGIBLE TO PARTICIPE IN THE STUDY:
OCULAR
1.ACTIVE INFECTIOUS UVEITIS. HOWEVER , IF THE UVEITIS IS THE CONSEQUENCE OF PREVIOUS INFECTIOUS DISEASE, SUCH AS TUBERCULOSIS AS LONG AS THE PREVIOUS INFECTIOUS DISEASE IS NO LONGER ACTIVE MAY BE ENROLLED.
2.CLINICALLY SUSPECTED OR CONFIRMED CENTRAL NERVOUS SYSTEM OR OCULAR LYMPHOMA.
3.PRIMARY DIAGNOSIS OF ANTERIOR UVEITIS.
4.UNCONTROLLED GLAUCOMA, EVIDENCED BY AN INTRAOCULAR PRESSURE OF 21 mmHg WHILE ON MEDICAL THERAPY, OR CHRONIC HYPOTONY (< 6 mmHg)
5.ANY IMPLANTABLE CORTICOSTEROID-ELUTING DEVICE (E.G. RETISERT, OZURDEX, I-VATION, TRIAMCINOLONA ACETONIDE [TA] INTRAVITREAL IMPLANT):
A)IF THE INVESTIGATOR CONFIRMS THE REMOVAL OF SUCH DEVICE MORE THAN 90 DAYS PRIOR TO DAY 1, THE SUBJECT WILL BE ELEGIBLE.
B)IF A SUBJECT RECEIVED A MEDIDUR IMPLANT, IT SHOULD HAVE BEEN IMPLANTED NO LESS THAN 3 YEARS AND 90 DAYS PRIOR TO DAY 1.
6.ANY SIGNIFICANT OCULAR DISEASE THAT COULD COMPROMISE VISION IN THE STUDY EYE. THESE INCLUDE, BUT ARE NOT LIMITEDTO:
A)DIABETIC RETINOPATHY: PROLIFERATIVE DIABETIC RETINOPATHY (PDR) OR NON-PROLIFERATIVE DIABETIC RETINOPATHY (NPDR) THAT COMPROMISE 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 DEGENRATION WITH ACTIVE SUBFOVEAL CHOROIDAL NEOVASCULARIZATION.
7.LENS OPACITIES OR OBSCURED OCULAR MEDIA OTHER THAN VITREOUS HAZE UPON ENROLLMENT SUCH  

Study & Design

• Study Type: Interventional
• Study Design: Not specified