Retinitis pigmentosa
Conditions
Interventions
Subretinal injection of low-dose DCV1-0401 (Simian immunodeficiency virus vector expressing human pigment epithelium-derived factor (hPEDF))
Subretinal injection of medium-dose DCV1-0401
Subretinal in
Sponsors
Kyushu University Hospital
University of Miyazaki Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects with retinitis pigmentosa diagnosed by two or more ophthalmic specialists 2) 40 years and above, and 70 years or younger 3) The mean retinal sensitivity measured by Humphrey perimeter (10-2 program) is less than 30 dB (central 4 points) 4) Interocular difference in visual acuity is less than or equal to 0.21 (logMAR converted value) 5) Interocular difference in visual field is less than or equal to twofold (Goldmann perimeter V-4e) 6) Interocular difference in the MD value measured by Humphrey perimeter (10-2 program) is less than or equal to 5 dB 7) Interocular difference in central retinal thickness measured by optical coherence tomography is less than or equal to 50 um 8) No interocular difference in the structure of outer retinal layer (ellipsoid zone) observed by optical coherence tomography 9) In case of subjects who are followed up over three years, interocular difference in the rate of change of visual acuity (logMAR converted value) and the MD value measured by Humphrey perimeter (10-2 program) is less than or equal to twofold 10) Difference in the mean retinal sensitivity measured in repeating tests using Humphrey perimeter (10-2 program) within 60 days before administration is binocularly less than or equal to 3 dB. If results from first and second tests don't fulfill the above criteria, the result from third test performed within 7 days from the second test is acceptable. 11) No significant pigmentation in ophthalmoscopic examination 12) Subjects who can give consent in writing by oneself (If subjects can not read the document because of reduction in visual function, both oral consent of the subject and signature of witness are necessary.)
Exclusion criteria
Exclusion criteria: 1) HIV antibody-positive 2) Decimal visual acuities of both eyes are less than 0.1, or lateral or bilateral blindness 3) Cone-rod dystrophy 4) Interocular difference in the condition of lens 5) Co-existence of glaucoma or ocular hypertension (intraocular pressure is more than or equal to 22 mmHg) 6) Co-existence of uveitis or optic neuritis 7) Retinal or subretinal pathological change observed by fundus examination (including fluorescein fundus angiography, laser scanning fundus photography), that is independent of retinitis pigmentosa 8) Visual field measured by Goldmann perimeter V-4e is less than 10 degree at the center area of vision 9) Loss or massive structural irregularity of the layer of retinal pigment epithelium on OCT (optical coherence tomography) at the supposed site of administration 10) Having severe allergy or previous history 11) Receiving chronic hemodialysis therapy 12) Severe heart dysfunction or heart failure 13) Sever hepatic dysfunction or liver cirrhosis 14) Active inflammatory diseases 15) History of cerebral hemorrhage or infarction within 6 months before agreement 16) Hematopoietic disorders 17) Alcoholism and/or drug dependence 18) Female subjects with pregnant or doubt of pregnancy. Breast-feeding female. 19) Subjects who are diagnosed with cancer or suspected to have cancer. History of treatment of malignancies within 5 years. 20) Disapprove of birth control during at least 12 months after the administration 21) Administration of Helenien, Unoprostone, and/or Ca antagonist intended for treatment of eye disease within 30 days before agreement 22) Taking the antiviral drug at the registration 23) Plan of operation other than administration of the investigational drug during this clinical trial 24) Entry into other clinical trial and/or clinical study, or history of entry within 6 months before agreement 25) Others: Subjects who are judged to be inappropriate by principal investigator or subinvestigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Rate of change of the mean retinal sensitivity (central 12 points) : Primary outcome measure of efficiency 2) Rate of change of the mean retinal sensitivity (central 4 points) : Secondary outcome measure of efficiency-1 3) Rate of change of the visual acuity (logMAR converted value) : Secondary outcome measure of efficiency-2 4) Amount of hPEDF protein in the aqueous humor : Exploratory outcome measure | — |
Countries
Japan
Contacts
Public ContactYusuke Murakami
Kyushu University Hospital Department of Ophthalmology
Outcome results
None listed