retinitis pigmentosa
Conditions
Brief summary
Primary endpoints will be the assessment of safety parameters: routine ophthalmic examination, intraocular inflammation, chorioretinal tolerance, questionnaire, vital signs, laboratory measurements
Detailed description
Functional tests: •distance and near visual acuity and refraction (near visual acuity not applicable for Cohort #4 patients); •colour vision; •visual fields; •global or full-field ERG; multifocal ERG*; •pupillometry (not applicable for the Cohort #3 & Cohort #4 patients); •microperimetry; •mobility test; •dark adaptation test; •full-field sensitivity threshold for the Cohort #3 & Cohort #4 patients; •evaluation of quality of life in adult patients, Morphologic tests: •fundus autofluorescence; •spectral domain optical coherence tomography (SD-OCT), Exploratory assessment: functional magnetic resonance imaging (fMRI)* * Not to be performed in Cohort #4
Interventions
DRUGATROPINE 1 POUR CENT FAURE
DRUGCHIBRO CADRON
DRUGcollyre en flacon
DRUGINDOCOLLYRE 0
DRUG1 %
DRUGAdenovirus associated viral vector serotype 5 containing the human pde6b gene
DRUGMYDRIASERT
Sponsors
eyeDNA Therapeutics
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints will be the assessment of safety parameters: routine ophthalmic examination, intraocular inflammation, chorioretinal tolerance, questionnaire, vital signs, laboratory measurements | — |
Secondary
| Measure | Time frame |
|---|---|
| Functional tests: •distance and near visual acuity and refraction (near visual acuity not applicable for Cohort #4 patients); •colour vision; •visual fields; •global or full-field ERG; multifocal ERG*; •pupillometry (not applicable for the Cohort #3 & Cohort #4 patients); •microperimetry; •mobility test; •dark adaptation test; •full-field sensitivity threshold for the Cohort #3 & Cohort #4 patients; •evaluation of quality of life in adult patients, Morphologic tests: •fundus autofluorescence; •spectral domain optical coherence tomography (SD-OCT), Exploratory assessment: functional magnetic resonance imaging (fMRI)* * Not to be performed in Cohort #4 | — |
Countries
France
Outcome results
None listed