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

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ClinicalTrials.gov Identifier: NCT01786395
Recruitment Status : Terminated
First Posted : February 8, 2013
Last Update Posted : January 29, 2016
Sponsor:
Information provided by (Responsible Party):
R-Tech Ueno, Ltd.

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.


Condition or disease Intervention/treatment Phase
Retinitis Pigmentosa Drug: UF-021 Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2013
Actual Primary Completion Date : April 2015


Arm Intervention/treatment
Experimental: - UF-021
UF-021 is experimental code for isopropyl unoprostone
Drug: UF-021
Other Name: isopropyl unoprostone (JAN)

Placebo Comparator: - Placebo Drug: Placebo



Primary Outcome Measures :
  1. Changes in the value of the mean retinal sensitivity at four central points through HFA (10-2) [ Time Frame: baseline and 1 year ]

Secondary Outcome Measures :
  1. - 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) [ Time Frame: baseline and 1 year ]
  2. - Changes in the value of the ETDRS visual acuity [ Time Frame: baseline and 1 year ]
  3. - Changes in the VFQ-25 (composite 8) value [ Time Frame: baseline and 1 year ]
  4. - Changes in the Goldmann visual field area within V4e isopter [ Time Frame: baseline and 1 year ]
  5. - Changes in the value of retinal thickness through OCT [ Time Frame: baseline and 1 year ]


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01786395


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

Responsible Party: R-Tech Ueno, Ltd.
ClinicalTrials.gov Identifier: NCT01786395     History of Changes
Other Study ID Numbers: UF-021-C003
First Posted: February 8, 2013    Key Record Dates
Last Update Posted: January 29, 2016
Last Verified: March 2013

Keywords provided by R-Tech Ueno, Ltd.:
UF-021
unoprostone
rp

Additional relevant MeSH terms:
Retinitis
Retinitis Pigmentosa
Cone-Rod Dystrophies
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn
Isopropyl unoprostone
Antihypertensive Agents