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

SANTEN INCORPORATED,0 个研究点目标入组 25 人开始时间: 2012年12月21日最近更新: 2023年9月4日

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•AT THE SCREENING VISIT, DAY -30 TO DAY -1, SUBJECTS MUST MEET ALL OF THE FOLLOWING 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 OF THE POSTERIOR SEGMENT 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 EXAMINATION, 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 A >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
•6. FEMALE PARTICIPANTS OF CHILDBEARING POTENTIAL MUST NOT BE PREGNANT OR BREAST-FEEDING, HAVE A NEGATIVE PREGNANCY TEST AT SCREENING AND MUST BE WILLING TO UNDERGO PREGNANCY TESTS THROUGHOUT THE STUDY
•7. 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

•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OF A PREVIOUS INFECTIOUS DISEASE, SUCH AS TUBERCULOSIS, THE PREVIOUS INFECTIOUS DISEASE MUST BE CONFIRMED AS NO LONGER ACTIVE.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. 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. OZURDEX, I-VATION, TRIAMCINOLONE ACETONIDE [TA] INTRAVITREAL IMPLANT) IN THE STUDY EYE:
•A. IF THE INVESTIGATOR CONFIRMS THE REMOVAL OF SUCH DEVICE MORE THAN 90 DAYS PRIOR TO DAY 1, THE SUBJECT WILL BE ELIGIBLE;
•B. IF A MEDIDUR IMPLANT OR RETISERT HAS BEEN IMPLANTED NO LESS THAN 3 YEARS AND 90 DAYS PRIOR TO DAY 1, THE SUBJECT WILL BE ELIGIBLE
•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 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 DEGENERATION WITH ACTIVE SUBFOVEAL CHOROIDAL NEOVASCULARIZATION

发起方

SANTEN INCORPORATED,