Phase I/IIa study of unoprostone release drug (URD) for safety and efficacy assessment on retinitis pigmentosa

JRCT ID: jRCT2021190021

Registered date:19/02/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: retinitis pigmentosa
• Date of first enrollment: 02/03/2020
• Target sample size: 3
• Study type: Interventional
• Intervention(s): Placement of URD on sclera at posterior segment for 12 months

Outcome(s)

Primary Outcome

1) Plasma concentration of unoprostone and M1
2) Blood test
3) Ophthalmic examination
4) Adverse event
5) Failure

Secondary Outcome

1) Visual field
2) Distant vision
3) Questionnaire about visual function
4) Multifocal electroretinogram
5) Local electroretinogram
6) Optical coherence tomography
7) Choroidal circulation by LSFG
8) Laser flare meter
9) Fundus autofluorescence

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Retinitis pigmentosa patients
2) Available for written informed consent
3) Patients older than 20 years old
4) Patients who agree to participate in this study
5) Decimal visual acuities of both eyes are more than 0.1, and interocular difference in visual acuity is less than or equal to 0.21 (logMAR converted value)
6) Ptients with no difficulty in evaluateing the thickness of IS/OS line in fovea by optical coherence tomography
7) Patients with no Interocular difference in the condition of lens
8) Visual field measured by Goldmann perimeter V-4e is more than 5 degree at the center area of vision, and interocular difference in visual field is less than 34%
9) Interocular difference in the MD value measured by Humphrey perimeter (10-2 program) is less than 12 dB, and difference in the mean retinal sensitivity measured in repeating tests of visit 1 and 2 or visit 2 and 3 using Humphrey perimeter (10-2 program) is less than 3 dB, and the mean retinal sensitivity measured by Humphrey perimeter (10-2 program) is less than 30 dB (central 4 points)

Exclude criteria

1) Length of eyeball is less than 21 mm or more than 27 mm
2) Difference in interocular length of eyeball is more than 2 mm
3) Patients who will have ophthalmic surgery except URD implantation/removal
4) Patients who had intraocular surgery within 24 weeks before URD implantation
5) Patients who had enucleated eye
6) Patients with galucoma and ocular hypertension
7) Patients with previous history of optic nerve disease and retinal detachment
8) Patients with complications of diabetic retinopathy, cone-rod dystrophy, and progressive retinal disease
9) Patients with complications of macular edema, cyst, epimacular membrane, and macular traction by OCT examination
10) Patients with intense choroid atrophy such as intense myopia and posterior staphyloma
11) Patients with complications of extraocular inflammation, infection, and severe dry eye
12) Patients with previous treatment history using isopropyl unoprostone and helenien within 12 weeks before informed consent
13) Patients with calcium antagonist and vitamin A within 12 weeks before informed consent
14) Patients who have drug allergies with ophthalmic anesthetic, fluorescein, and prostaglandin
15) Pregnant woman, maternal, lactating woman
16) Patients with complications of severe kidney disease, liver disease, cranial nerve disease, Heart disease, and malignant tumor
17) Patients with complications of autoimmune disease, diabetes, mental disorders, cognitive impairment, and hay fever
18) Patients who had other clinical trial and clinical research within 24 weeks before informed consent
19) Patients who have been considered inappropriate as study subjects by the investigator or sub-investigator

Related Information

• Primary Sponsor: Abe Toshiaki
• Source(s) of Monetary Support: AMED