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

NCT ID: NCT01786395

Last Updated: 2016-01-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31

Brief Summary

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.

Conditions

Retinitis Pigmentosa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

- UF-021

UF-021 is experimental code for isopropyl unoprostone

Group Type: EXPERIMENTAL

UF-021

Intervention Type: DRUG

- Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

UF-021

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

isopropyl unoprostone (JAN)

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

R-Tech Ueno, Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nagoya, Aichi-ken, Japan

Hirosaki, Aomori, Japan

Chiba, Chiba, Japan

Matsuyama, Ehime, Japan

Fukuoka, Fukuoka, Japan

Maebashi, Gunma, Japan

Kure, Hiroshima, Japan

Sapporo, Hokkaido, Japan

Kobe, Hyōgo, Japan

Mito, Ibaraki, Japan

Morioka, Iwate, Japan

Kumamoto, Kumamoto, Japan

Kyoto, Kyoto, Japan

Tsu, Mie-ken, Japan

Sendai, Miyagi, Japan

Miyakonojō, Miyazaki, Japan

Miyazaki, Miyazaki, Japan

Beppu, Oita Prefecture, Japan

Okayama, Okayama-ken, Japan

Tamano, Okayama-ken, Japan

Osaka, Osaka, Japan

Sayama, Osaka, Japan

Izumo, Shimane, Japan

Hamamatsu, Shizuoka, Japan

Ohtawara, Tochigi, Japan

Tokushima, Tokushima, Japan

Bunkyo-ku, Tokyo, Japan

Chiyoda-ku, Tokyo, Japan

Itabashi-ku, Tokyo, Japan

Minato-ku, Tokyo, Japan

Mitaka, Tokyo, Japan

Toyama, Toyama, Japan

Wakayama, Wakayama, Japan

Chūō, Yamanashi, Japan

Countries

Japan

Other Identifiers

UF-021-C003

Identifier Type: -

Identifier Source: org_study_id