None listed
Conditions
Interventions
THIS PROTOCOL IS IMPLEMENTED TO CONDUCT 2 IDENTICAL PHASE III STUDIES WHICH IS DEFINED BY 2 GEOGRAPHIC REGIONS AS FOLLOWS:
• GEOGRAPHIC REGION 1 — USA AND LATIN AMERICAN COUNTRIES
• GEOGRAPHIC R
1, OR SUBJECTS WHO HAVE ACHIEVED A 2 UNIT REDUCTION (I.E., 4 TO 2, 3 TO 1, ETC.) FROM BASELINE IN THEIR VITREOUS HAZE SCORE AT ANY VISIT BETWEEN MONTH 6-12 AND HAVE NOT RECEIVED RESCUE THERAPY. SUBJEC
Sponsors
SANTEN INCORPORATED,
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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OF A PREVIOUS INFECTIOUS DISEASE, SUCH AS TUBERCULOSIS, THE PREVIOUS INFECTIOUS DISEASE MUST BE CONFIRMED AS NO LONGER ACTIVE. 2.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
Countries
Argentina, Austria, Brazil, Chile, Colombia, France, Germany, India, Israel, Italy, Japan, Netherlands, Peru, Poland, Spain, Turkey, United Kindgdom, United States
Contacts
Public ContactMAYTE MILAGROS DE LA CRUZ
PPD Peru S.A.C.
Outcome results
None listed