Clinical study on the relationships between disease progression and inflammation in retinitis pigmentosa

JRCT ID: jRCT1070210092

Registered date:09/11/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Retinitis pigmentosa
• Date of first enrollment: 12/10/2021
• Target sample size: 100
• Study type: Observational

Outcome(s)

• Primary Outcome: Proportion of the progression of retinal sensitivity loss in Humphrey 10-2 perimetry tests

Secondary Outcome

1. Change rate of ETDRS letter
2. Change rate of ellipsoid zone length (horizontal and vertical) in OCT
3. Change rate of autofluorescence ring area in fundus autofluorescence
4. Change rate of mean retinal sensitivity at the central 4 points in Humphrey 10-2 tests
5. Change rate of mean retinal sensitivity at the central 12 points in Humphrey 10-2 tests
6. Change rate of mean deviation in Humphrey 10-2 tests
7. Assoiation between progression profiles (primary outcome and secondary outocomes 1-6) and inflammatory markers

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 70age old
• Gender: Both

Include criteria

(1) Patients diagnosed as typical retinitis pigmentosa (genetic diagnosis is unnecessary)
(2) Patients who understand the design/purpose of the study and have the ability to declare consent by her/himself
(3) Patients whose age is 20-70 at the time of informed consent
(4) Patients whose mean retinal sensitivity within the central 4 degree area (central 12 points) is 10 dB or above in the Humphery 10-2 perimetry test
(5) Patients whose central foveal thickness is 250 micrometer or less in the OCT measurement

Exclude criteria

(1) Patients with anemia (Hb: 8g/dl or less)
(2) Patients who are in poor general condition (PS: 3 or above)
(3) Patietns with glaucoma or ocular hypertension (Intraocular pressure: 22 mmHg or above)
(4) Patients with uveitis or optic neuritis
(5) Patients with retinal disorders (e.g. retinal hemorrhage, retinal edema, proliferative tissue) that are not related with retinitis pigmentosa
(6) Patients with severe systemic complications
(7) Patients who are judged ineligible for the study by investigators

Related Information

• Primary Sponsor: Sonoda Koh-Hei
• Secondary Sponsor: Murakami Yusuke
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development