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Retinitis PigmentosaPhase 3NCT01786395

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

A Phase 3 study testing UF-021 in people with Retinitis Pigmentosa, run by R-Tech Ueno, Ltd. at 34 sites in Japan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Retinitis Pigmentosa
What is being tested?
UF-021
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
202 participants
Where
34 sitesJapan
Study dates
Mar 2013to Apr 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: 20 years or more, 70 years or less (at obtaining informed consent)
  • Medical examination classification: Outpatients
  • Observation, examination, and surveillance in accordance with the study protocol are judged to be feasible.
  • ETDRS visual acuity test is judged to be feasible at a distance of 4 meters.
  • HFA (10-2) test is judged to be feasible by investigator.
  • Goldmann perimetry shows concentric central visual field loss (including a ring scotoma) with the central 30 degrees or less.
  • 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.)

Who cannot join

  • Judged to have difficulty by investigator for visiting the hospital and returning home safely over the study period.
  • Planning to undergo an ophthalmic operation for eye for efficacy evaluation during study period.
  • Current treatment for glaucoma or ocular hypertension.
  • Prior ophthalmectomy or evisceration of an eye
  • Intraocular surgery within the past five months.
  • 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
Show all 16Show fewer
  • Complications of diabetic retinopathy.
  • Complications of external eye inflammation, infectious diseases, or severe dry eye.
  • Use of isopropyl unoprostone in the past or present.
  • Use of the following drugs within 31 days before obtaining informed consent. Calcium antagonists, Dark adaptation improvement drug (helenien)
  • Participation in UF-021 phase Ⅱ trial (including subjects assigned to the placebo group).
  • Participation in other clinical studies within the past 6 months (However, any subject who has not been administered an investigational product will be accepted)
  • 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.
  • Cone-rod dystrophy where cone function was primarily impaired
  • History of optic nerve disease in the eye for efficacy evaluation
  • 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

Trial locations and contacts

34 sites in 1 country.

34 sites in 1 country

Japan34 sites

  • Study site

    Beppu, Oita Prefecture

  • Study site

    Bunkyo-ku, Tokyo

  • Study site

    Chiba, Chiba

  • Study site

    Chiyoda-ku, Tokyo

  • Study site

    Chūō, Yamanashi

  • Study site

    Fukuoka, Fukuoka

  • Study site

    Hamamatsu, Shizuoka

  • Study site

    Hirosaki, Aomori

  • Study site

    Izumo, Shimane

  • Study site

    Kobe, Hyōgo

  • Study site

    Kumamoto, Kumamoto

  • Study site

    Kure, Hiroshima

  • Study site

    Kyoto, Kyoto

  • Study site

    Maebashi, Gunma

  • Study site

    Matsuyama, Ehime

  • Study site

    Minato-ku, Tokyo, Japan

  • Study site

    Mitaka, Tokyo

  • Study site

    Mito, Ibaraki

  • Study site

    Miyakonojō, Miyazaki

  • Study site

    Miyazaki, Miyazaki

  • Study site

    Morioka, Iwate

  • Study site

    Nagoya, Aichi-ken

  • Study site

    Ohtawara, Tochigi

  • Study site

    Okayama, Okayama-ken

  • Study site

    Osaka, Osaka

  • Study site

    Sapporo, Hokkaido

  • Study site

    Sayama, Osaka

  • Study site

    Sendai, Miyagi

  • Study site

    tabashi City, Tokyo

  • Study site

    Tamano, Okayama-ken

  • Study site

    Tokushima, Tokushima

  • Study site

    Toyama, Toyama

  • Study site

    Tsu, Mie-ken

  • Study site

    Wakayama, Wakayama

Other trials in Japan

About this study

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

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.

Being tested
UF-021, Placebo
Keywords
UF-021, unoprostone, rp
Medical subject headings
Retinitis Pigmentosa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UF-021Drug

    Also called isopropyl unoprostone (JAN)

  • PlaceboDrug

Study groups in NCT01786395
Study groupRoleWhat they receive
- UF-021ExperimentalUF-021 is experimental code for isopropyl unoprostone
Receives: Drug: UF-021
- PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in the value of the mean retinal sensitivity at four central points through HFA (10-2)

    Measured: baseline and 1 year

Secondary outcomes (5)

  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)

    Measured: baseline and 1 year

  2. - Changes in the value of the ETDRS visual acuity

    Measured: baseline and 1 year

  3. - Changes in the VFQ-25 (composite 8) value

    Measured: baseline and 1 year

  4. - Changes in the Goldmann visual field area within V4e isopter

    Measured: baseline and 1 year

  5. - Changes in the value of retinal thickness through OCT

    Measured: baseline and 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
202 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01786395
Sponsor's protocol ID
UF-021-C003
Status last verified
Mar 2013
First submitted
23 Jan 2013
Last updated
29 Jan 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing UF-021 in people with Retinitis Pigmentosa, run by R-Tech Ueno, Ltd. at 34 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in the value of the mean retinal sensitivity at four central points through HFA (10-2) (time frame: baseline and 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01786395.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2016.

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