Phase 3 Clinical Study of UF-021 for Retinitis Pigmentosa - Evaluation for a Comparative Double Masked Placebo Controlled Study Period and a Continuous Administration Period
R-Tech Ueno, Ltd.
info@rtueno.co.jp
Interventional
The comparative study period is placebo-controlled, double-masked study.
In the 52 weeks continuous administration period, all the patients are treated with UF-021 eye drops.
3
1)Medical examination classification: Outpatients
2)Observation, examination, and surveillance in accordance with the study protocol are judged to be feasible.
3)ETDRS visual acuity test is judged to be feasible at a distance of 4 meters.
4)HFA (10-2) test is judged to be feasible by investigator.
5)Goldmann perimetry shows concentric central visual field loss (including a ring scotoma) with the central 30 degrees or less.
6)The difference in the mean retinal sensitivity at four central points must be less than 3 dB between two measurements with HFA (10-2) conducted within 31 days and both values are worse than 30 dB.
(When this criterion is not met after two tests, a 3rd measurement will be implemented.)
1)Judged to have difficulty by investigator for visiting the hospital and returning home safely over the study period.
2)Planning to undergo an ophthalmic operation for eye for efficacy evaluation during study period.
3)Current treatment for glaucoma or ocular hypertension.
4)Prior ophthalmectomy or evisceration of an eye
5)Intraocular surgery within the past five months.
6)History of allergy to drugs (instillation narcotics, fluorescein, etc.) that will be used during the clinical study, and to drugs similar to the investigational product
7)Complications of diabetic retinopathy.
8)Complications of external eye inflammation, infectious diseases, or severe dry eye.
9)Use of isopropyl unoprostone in the past or present.
10)Use of the following drugs within 31 days before obtaining informed consent.
Calcium antagonists, Dark adaptation improvement drug (helenien)
11)Participation in UF-021 phase 2 trial (including subjectss assigned to the placebo group).
12)Participation in other clinical studies within the past 6 months (However, any subject who has not been administered an investigational product will be accepted)
13)Pregnancy or the possibility of becoming pregnant. Currently breastfeeding. Childbearing patients who wish to become pregnant during the clinical study period and are not using appropriate contraceptive measures.
14)Cone-rod dystrophy where cone function was primarily impaired
15)History of optic nerve disease in the eye for efficacy evaluation
16)Complications of a moderate or more severe central cataract, an anterior subcapsular cataract, a posterior subcapsular cataract, and posterior capsule opacification that may exert a major influence on visual acuity in the eye for efficacy evaluation
17)History of retinal detachment (including cases that have undergone surgery) or complications of retinal disease that may progress in the eye for efficacy evaluation
18)Complications of marked macular oedema (or a cyst), an epimacular membrane or macular traction on the optical coherence tomography (OCT) findings in the eye for efficacy evaluation
19)Severe renal disease (blood urea nitrogen: 25 mg/dL or more and/or serum creatinine: 1.5 mg/dL or more), hepatic disease (aspartate aminotransferase [glutamic-oxaloacetic transaminase]) and/or alanine aminotransferase [glutamic-pyruvic transaminase] is 100 U or more), diabetes mellitus with inadequate control, complications of unstable angina, or a history of myocardial infarction
20age old over
70age old under
Both
Retinitis Pigmentosa
investigational material(s)
Generic name etc : UF-021(isopropyl unoprostone)
INN of investigational material :
Therapeutic category code : 131 Agents for ophthalmic use
Dosage and Administration for Investigational material : Eye drop
- Efficacy : Retinal sensitivity
- Safety
Efficacy : Other retinal sensitivities, visual acuity, VFQ-25, visual field area, OCT test.
