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

Clinical study on the association between natural clinical course and inflammatory markers in retinitis pigmentosa

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1070210092

Enrollment

100

Registered

2021-11-09

Start date

2021-10-12

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinitis pigmentosa Inherited retinal dystrophy

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Proportion of the progression of retinal sensitivity loss in Humphrey 10-2 perimetry tests	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Contacts

Public ContactYusuke Murakami

Kyushu University Hospital

murakami.yusuke.407@m.kyushu-u.ac.jp+81-92-642-5648

Outcome results