Phase III Efficacy and Safety Clinical Study of UF-021 for Treatment of Retinitis Pigmentosa

Phase III Clinical Study of UF-021 for Retinitis Pigmentosa - Evaluation for a Comparative Double Masked Placebo Controlled Study Period and a Continuous Administration Period

This study is a multicenter trial performed in Japan, consisting of a comparative study period and a continuous administration period.

Effect of 0.15% UF-021 eye drops on improvement in central retinal sensitivity with HFA will be verified in 52 weeks comparative study period by a placebo-controlled, double-masked study in patients with retinitis pigmentosa.

The safety of same eye drops will also be examined in 52 weeks continuous administration period, in all the patients who completed the comparative study period.

Study Overview

• Status: Terminated
• Conditions: Retinitis Pigmentosa
• Intervention / Treatment: Drug: Placebo; Drug: UF-021

• Study Type: Interventional
• Enrollment (Actual): 202
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Chiba, Japan
  • Fukuoka, Japan
  • Kumamoto, Japan
  • Kyoto, Japan
  • Miyazaki, Japan
  • Okayama, Japan
  • Osaka, Japan
  • Tokushima, Japan
  • Toyama, Japan
  • Wakayama, Japan
  • Aichi
    • Nagoya, Aichi, Japan
  • Aomori
    • Hirosaki, Aomori, Japan
  • Ehime
    • Matsuyama, Ehime, Japan
  • Gunma
    • Maebashi, Gunma, Japan
  • Hiroshima
    • Kure, Hiroshima, Japan
  • Hokkaido
    • Sapporo, Hokkaido, Japan
  • Hyogo
    • Kobe, Hyogo, Japan
  • Ibaraki
    • Mito, Ibaraki, Japan
  • Iwate
    • Morioka, Iwate, Japan
  • Mie
    • Tsu, Mie, Japan
  • Miyagi
    • Sendai, Miyagi, Japan
  • Miyazaki
    • Miyakonojo, Miyazaki, Japan
  • Oita
    • Beppu, Oita, Japan
  • Okayama
    • Tamano, Okayama, Japan
  • Osaka
    • Osakasayama, Osaka, Japan
  • Shimane
    • Izumo, Shimane, Japan
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan
  • Tochigi
    • Ohtawara, Tochigi, Japan
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan
    • Chiyoda-ku, Tokyo, Japan
    • Itabashi-ku, Tokyo, Japan
    • Minato-ku, Tokyo, Japan, Japan
    • Mitaka, Tokyo, Japan
  • Yamanashi
    • Chuo, Yamanashi, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age: 20 years or more, 70 years or less (at obtaining informed consent)
2. Medical examination classification: Outpatients
3. Observation, examination, and surveillance in accordance with the study protocol are judged to be feasible.
4. ETDRS visual acuity test is judged to be feasible at a distance of 4 meters.
5. HFA (10-2) test is judged to be feasible by investigator.
6. Goldmann perimetry shows concentric central visual field loss (including a ring scotoma) with the central 30 degrees or less.
7. The difference in the mean retinal sensitivity at four central points must be less than 3 dB between two reliable measurements with HFA (10-2) (SITA-Standard) 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 within 31 days from the 2nd test. The difference between the 3rd reliable measurement value and the 1st or 2nd measurements must be less than 3 dB, and both values are worse than 30 dB; the most recent data will be regarded as the data acquired before instillation.)

Exclusion Criteria:

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 Ⅱ trial (including subjects 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 (grade 3 of the Emery classification) 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: - UF-021; UF-021 is experimental code for isopropyl unoprostone	Drug: UF-021; Other Names: isopropyl unoprostone (JAN)
PLACEBO_COMPARATOR: - Placebo	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in the value of the mean retinal sensitivity at four central points through HFA (10-2)	baseline and 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
- Changes in the value of the retinal sensitivity through HFA (10-2) (MD value, mean retinal sensitivity at 12 central points /24 central points /68 central points)	baseline and 1 year
- Changes in the value of the ETDRS visual acuity	baseline and 1 year
- Changes in the VFQ-25 (composite 8) value	baseline and 1 year
- Changes in the Goldmann visual field area within V4e isopter	baseline and 1 year
- Changes in the value of retinal thickness through OCT	baseline and 1 year

Collaborators and Investigators

• Sponsor: R-Tech Ueno, Ltd.

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (ACTUAL): April 1, 2015

Study Registration Dates

• First Submitted: January 23, 2013
• First Submitted That Met QC Criteria: February 5, 2013
• First Posted (ESTIMATE): February 8, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): January 29, 2016
• Last Update Submitted That Met QC Criteria: January 27, 2016
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: UF-021; unoprostone; rp
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Retinal Dystrophies; Retinitis; Retinitis Pigmentosa; Antihypertensive Agents; Isopropyl unoprostone
• Other Study ID Numbers: UF-021-C003